Trial Outcomes & Findings for Study of Durvalumab With Tremelimumab Versus SoC as 1st Line Therapy in Metastatic Non Small-Cell Lung Cancer (NSCLC) (NEPTUNE) (NCT NCT02542293)

Last Updated: 2026-02-12

Results Overview

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. Median OS was calculated using the Kaplan-Meier technique.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

953 participants

Primary outcome timeframe

From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).

Results posted on

2026-02-12

Participant Flow

A total of 192 centers across 29 countries in North America, Latin America, Asia, Europe and Gulf countries randomized adults with epidermal growth factor receptor and anaplastic lymphoma kinase wild-type advanced or metastatic non-small-cell lung cancer (NSCLC) in this study. First participant was enrolled on 03 November 2015 and final data cut-off (DCO) date was 24 June 2019 for Global cohort and 21 September 2020 for China cohort. SoC = standard of care

823 participants in Global cohort and 160 participants in China cohort were randomized in 1:1 ratio to receive durvalumab + tremelimumab or SoC chemotherapy. China cohort comprised participants from mainland China (30 from Global cohort and 130 randomized after end of Global cohort recruitment). Thus, 953 unique participants were randomized in the study overall. Participants included in both cohorts for Started, Completed and Reasons for Not Completed are not double-counted for participant flow.

Participant milestones

Participant milestones
Measure	All Participants: Durvalumab + Tremelimumab Participants received durvalumab 20 milligram per kilogram (mg/kg) and tremelimumab 1 mg/kg intravenous (IV) infusion every 4 weeks (Q4W) in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective disease progression (PD), initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	All Participants: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/square meter (m\^2) and carboplatin area under the plasma concentration curve (AUC) 5 or 6 mg\minute per milliliter (mg\min/mL). 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Overall Study STARTED	474	479
Overall Study Randomized in Global Cohort	410	413
Overall Study Received Treatment in Global Cohort	410	399
Overall Study Randomized in China Cohort	78	82
Overall Study Received Treatment in China Cohort	77	78
Overall Study Included in Both Cohorts (Global and China)	14	16
Overall Study Ongoing in Study at DCO for Final Analysis in Global Cohort	75	67
Overall Study Ongoing in Study at DCO for Final Analysis in China Cohort	27	18
Overall Study COMPLETED	99	83
Overall Study NOT COMPLETED	375	396

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants: Durvalumab + Tremelimumab Participants received durvalumab 20 milligram per kilogram (mg/kg) and tremelimumab 1 mg/kg intravenous (IV) infusion every 4 weeks (Q4W) in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective disease progression (PD), initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	All Participants: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/square meter (m\^2) and carboplatin area under the plasma concentration curve (AUC) 5 or 6 mg\minute per milliliter (mg\min/mL). 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Overall Study Death	367	377
Overall Study Withdrawal by Subject	8	19

Baseline Characteristics

Baseline data is presented for all participants, as well as separately for the Global and China cohorts.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).

Population: The bTMB ≥20 mut/Mb analysis set included the subset of participants in the FAS whose blood TMB status was ≥20 mut/Mb at baseline as defined by the GuardantOMNI CDx assay. Only participants randomized in Global cohort were analyzed as bTMB and tissue tumor mutational burden (tTMB) testing was not performed in China cohort.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=69 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=60 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Overall Survival (OS); Global Cohort: Blood Tumor Mutational Burden (bTMB) ≥20 Mutations Per Megabase (Mut/Mb) Analysis Set	11.7 months Interval 8.6 to 15.2	9.1 months Interval 7.8 to 12.6	—	—

PRIMARY outcome

Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the China cohort DCO date (a maximum of approximately 44 months).

Population: The China PD-L1-negative population analysis set included the subset of participants in the China FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Only participants randomized in China cohort were analyzed.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=26 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=29 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
OS; China Cohort: China Programmed Cell Death Ligand 1 (PD-L1) Negative NSCLC Analysis Set	15.0 months Interval 10.5 to 27.4	11.7 months Interval 8.6 to 20.5	—	—

SECONDARY outcome

Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global cohort DCO date (a maximum of approximately 44 months).

Population: Participants included in bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, PD-L1-Negative NSCLC, bTMB \<20 mut/Mb, bTMB non-evaluable population, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.

OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at time of analysis was censored based on last recorded date on which participant was known to be alive. bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb and bTMB \<20 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥16 mut/Mb, ≥12 mut/Mb and \<20 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). bTMB non-evaluable analysis set included the subset of participants in FAS whose bTMB status at baseline could not be determined by the GuardantOMNI CDx assay or whose sample was not available. tTMB analysis sets are defined same as the bTMB analysis sets.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥16 mut/Mb analysis set	12.1 months Interval 8.6 to 15.0	11.9 months Interval 8.5 to 15.9	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥12 mut/Mb analysis set	10.9 months Interval 8.6 to 12.6	10.3 months Interval 8.3 to 12.9	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets PD-L1 negative analysis set	11.1 months Interval 8.1 to 14.7	12.5 months Interval 9.9 to 16.2	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB <20 mut/Mb analysis set	9.9 months Interval 7.7 to 12.8	11.5 months Interval 8.8 to 13.7	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB non-evaluable analysis set	9.3 months Interval 7.2 to 15.5	10.4 months Interval 9.4 to 13.8	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥14 mut/Mb analysis set	17.5 months Interval 9.8 to Upper limit was not reached.	10.6 months Interval 7.0 to 20.9	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥12 mut/Mb analysis set	11.1 months Interval 7.0 to 17.5	13.9 months Interval 9.0 to 17.9	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥10 mut/Mb analysis set	11.1 months Interval 7.2 to 15.7	10.6 months Interval 9.0 to 15.7	—	—
OS; Global Cohort: bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, PD-L1-Negative NSCLC, bTMB <20 Mut/Mb, bTMB Non-Evaluable Population, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥8 mut/Mb analysis set	11.0 months Interval 7.8 to 15.7	10.2 months Interval 8.0 to 13.5	—	—

SECONDARY outcome

Timeframe: From baseline (Day 1, Week 0) until death due to any cause, assessed up to the Global or China cohort DCO dates, as applicable (a maximum of approximately 44 months) for each cohort.

Population: Participants included in FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets are reported in this outcome measure.

The OS was defined as time from date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). Any participant not known to have died at the time of analysis was censored based on last recorded date on which participant was known to be alive. Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses. PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab n=78 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy n=82 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets FAS	10.9 months Interval 9.3 to 12.6	12.1 months Interval 10.3 to 13.5	20.0 months Interval 15.0 to 28.7	14.1 months Interval 9.5 to 19.4
OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1 TC ≥25% analysis set	12.2 months Interval 9.7 to 15.2	10.4 months Interval 8.6 to 12.2	36.6 months Interval 15.5 to Upper limit was not reached.	15.8 months Interval 9.0 to 26.9
OS; Global and China Cohorts: FAS, PD-L1 Tumor Cell (TC) ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1 TC ≥50% analysis set	14.1 months Interval 10.0 to 19.3	10.5 months Interval 8.7 to 12.6	36.6 months Interval 16.9 to Upper limit was not reached.	15.8 months Interval 9.0 to 26.9

SECONDARY outcome

Timeframe: Tumour scans performed at baseline and every 6 weeks up to 48 weeks relative to date of randomization, then every 8 weeks thereafter until confirmed PD/death. Up to Global cohort DCO date (approximately 44 months).

Population: Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.

The PFS (per Response Evaluation Criteria in Solid Tumors, version 1.1 \[RECIST 1.1\] using Investigator assessments) was defined as the time from the date of randomization until the date of objective PD or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥10 mut/Mb analysis set	4.3 months Interval 2.8 to 5.5	5.1 months Interval 4.2 to 5.8	—	—
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥8 mut/Mb analysis set	4.4 months Interval 2.9 to 5.5	5.0 months Interval 4.2 to 5.6	—	—
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥20 mut/Mb analysis set	4.2 months Interval 2.7 to 5.6	5.1 months Interval 4.2 to 5.6	—	—
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥16 mut/Mb analysis set	4.2 months Interval 2.8 to 5.5	5.5 months Interval 4.4 to 5.8	—	—
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥12 mut/Mb analysis set	3.9 months Interval 2.8 to 4.8	5.1 months Interval 4.4 to 5.6	—	—
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥14 mut/Mb analysis set	8.7 months Interval 5.2 to 22.3	5.8 months Interval 4.4 to 7.9	—	—
Progression-Free Survival (PFS); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥12 mut/Mb analysis set	5.2 months Interval 3.8 to 6.9	5.8 months Interval 4.2 to 6.6	—	—

SECONDARY outcome

Population: Participants included in PD-L1-negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets are reported in this outcome measure.

PFS (per RECIST 1.1 using Investigator assessments) was defined as time from date of randomization until date of objective PD or death regardless of whether participant withdrew from randomized therapy or received another anticancer therapy prior to progression (ie, date of PFS event or censoring - date of randomization + 1). PD-L1-negative analysis set included subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: FAS included all randomized participants prior to end of global recruitment. China Cohort: China FAS included all randomized participants in China cohort and were used for all China only efficacy analyses. PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included subset of participants in FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab n=78 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy n=82 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1-negative NSCLC analysis set	4.1 months Interval 2.8 to 5.2	5.6 months Interval 4.6 to 6.0	5.1 months Interval 2.8 to 7.2	6.0 months Interval 4.0 to 7.5
PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets FAS	4.0 months Interval 2.9 to 4.2	5.6 months Interval 5.3 to 5.7	4.2 months Interval 2.8 to 7.2	6.0 months Interval 5.5 to 7.5
PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1 TC ≥25% analysis set	4.2 months Interval 3.2 to 5.7	5.4 months Interval 4.4 to 5.6	6.8 months Interval 4.1 to 8.4	5.7 months Interval 4.2 to 8.5
PFS; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1 TC ≥50% analysis set	4.6 months Interval 3.1 to 6.0	5.4 months Interval 4.3 to 5.6	6.8 months Interval 4.2 to 20.2	5.7 months Interval 4.2 to 8.5

SECONDARY outcome

Population: Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, bTMB ≥12 mut/Mb, tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb, and tTMB ≥8 mut/Mb analysis sets with measurable disease are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.

The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) prior to PD. bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay. tTMB ≥14 mut/Mb, tTMB ≥12 mut/Mb, tTMB ≥10 mut/Mb and tTMB ≥8 mut/Mb analysis sets included the subset of participants in FAS whose tTMB status was ≥14 mut/Mb, ≥12 mut/Mb, ≥10 mut/Mb and ≥8 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥12 mut/Mb analysis set	28.7 percentage of participants	42.0 percentage of participants	—	—
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥20 mut/Mb analysis set	27.5 percentage of participants	43.3 percentage of participants	—	—
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets bTMB ≥16 mut/Mb analysis set	31.2 percentage of participants	46.1 percentage of participants	—	—
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥14 mut/Mb analysis set	61.3 percentage of participants	44.7 percentage of participants	—	—
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥12 mut/Mb analysis set	42.6 percentage of participants	41.8 percentage of participants	—	—
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥10 mut/Mb analysis set	37.7 percentage of participants	42.5 percentage of participants	—	—
Objective Response Rate (ORR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, bTMB ≥12 Mut/Mb, tTMB ≥14 Mut/Mb, tTMB ≥12 Mut/Mb, tTMB ≥10 Mut/Mb, and tTMB ≥8 Mut/Mb Analysis Sets tTMB ≥8 mut/Mb analysis set	36.7 percentage of participants	41.2 percentage of participants	—	—

SECONDARY outcome

Population: Participants included in PD-L1-negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% analysis sets with measurable disease are reported in this outcome measure.

The ORR (per RECIST 1.1 using Investigator assessments) was defined as the percentage of participants with at least 1 visit response of CR or PR prior to PD. PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses. PD-L1 TC ≥25% and PD-L1 TC ≥50% analysis sets included the subset of participants in the FAS whose PD-L1 status was TC ≥25% and TC ≥50% membrane expression in tumoral tissue, respectively at baseline as defined by the Ventana SP263 PD-L1 Assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab n=78 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy n=82 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1-negative NSCLC analysis set	23.1 percentage of participants	38.8 percentage of participants	23.1 percentage of participants	41.4 percentage of participants
ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets FAS	25.9 percentage of participants	41.7 percentage of participants	35.9 percentage of participants	39.0 percentage of participants
ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1 TC ≥25% analysis set	35.2 percentage of participants	43.9 percentage of participants	54.8 percentage of participants	40.6 percentage of participants
ORR; Global and China Cohorts: PD-L1-Negative NSCLC, FAS, PD-L1 TC ≥25%, and PD-L1 TC ≥50% Analysis Sets PD-L1 TC ≥50% analysis set	37.4 percentage of participants	44.0 percentage of participants	60.0 percentage of participants	46.4 percentage of participants

SECONDARY outcome

Population: Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, and bTMB ≥12 mut/Mb analysis sets are reported in this outcome measure. Only participants with objective response and randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=106 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=172 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥12 mut/Mb analysis set	11.5 months Interval 6.7 to 18.8	4.3 months Interval 3.0 to 5.6	—	—
Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥20 mut/Mb analysis set	11.6 months Interval 6.7 to 21.5	4.2 months Interval 3.0 to 6.9	—	—
Duration of Response (DoR); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥16 mut/Mb analysis set	10.6 months Interval 4.2 to 21.5	4.3 months Interval 3.0 to 5.9	—	—

SECONDARY outcome

Population: Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure. Only participants with objective response were included in this analysis.

DoR (per RECIST 1.1 using Investigator assessments) was defined as the time from the date of first documented response (CR or PR) until the first date of documented progression or death in the absence of PD (ie, date of PFS event or censoring - date of first response + 1). PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=106 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=172 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab n=28 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy n=32 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets PD-L1-negative NSCLC analysis set	10.2 months Interval 2.8 to 18.8	4.9 months Interval 4.2 to 6.1	10.5 months Interval 1.4 to Upper limit was not reached.	6.1 months Interval 3.0 to 11.7
DoR; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets FAS	11.1 months Interval 6.9 to 15.2	4.9 months Interval 4.2 to 5.6	12.9 months Interval 5.4 to 33.6	6.1 months Interval 4.4 to 7.2

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Population: Participants included in bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb, and bTMB ≥12 mut/Mb analysis sets are reported in this outcome measure. Only participants randomized in Global cohort were analyzed as bTMB and tTMB testing was not performed in China cohort.

The APF12 was defined as the percentage of participants who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=143 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=138 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥16 mut/Mb analysis set	22.0 percentage of participants Interval 14.1 to 31.1	12.3 percentage of participants Interval 6.1 to 20.8	—	—
Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥20 mut/Mb analysis set	25.6 percentage of participants Interval 15.7 to 36.6	7.0 percentage of participants Interval 1.9 to 16.8	—	—
Alive and Progression-Free at 12 Months (APF12); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥12 mut/Mb analysis set	21.6 percentage of participants Interval 15.2 to 28.9	13.8 percentage of participants Interval 8.3 to 20.6	—	—

SECONDARY outcome

Timeframe: Tumour scans performed at baseline then every 6 weeks up to 12 months.

Population: Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure.

The APF12 was defined as the percentage of patients who were alive and progression free at 12 months from randomization (ie, PFS rate at 12 months). PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab n=78 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy n=82 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets PD-L1-negative NSCLC analysis set	18.2 percentage of participants Interval 10.9 to 26.9	12.1 percentage of participants Interval 6.3 to 19.9	15.6 percentage of participants Interval 4.0 to 34.4	11.3 percentage of participants Interval 2.3 to 28.5
APF12; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets FAS	20.2 percentage of participants Interval 16.4 to 24.3	14.9 percentage of participants Interval 11.4 to 18.9	23.9 percentage of participants Interval 14.8 to 34.2	16.6 percentage of participants Interval 8.5 to 27.0

SECONDARY outcome

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=143 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=138 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥20 mut/Mb analysis set	10.6 months Interval 8.5 to 14.4	8.6 months Interval 7.3 to 12.6	—	—
Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥16 mut/Mb analysis set	10.9 months Interval 8.5 to 14.1	10.5 months Interval 8.0 to 13.2	—	—
Time From Randomization to Second Progression or Death (PFS2); Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets bTMB ≥12 mut/Mb analysis set	9.9 months Interval 8.2 to 11.7	9.0 months Interval 7.8 to 10.8	—	—

SECONDARY outcome

Population: Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure.

The PFS2 was defined as the time from the date of randomization to the earliest of the progression events subsequent to that used for the primary variable PFS, or death (ie, date of PFS2 event or censoring - date of randomization + 1). PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab n=78 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy n=82 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets PD-L1-negative NSCLC analysis set	9.1 months Interval 6.9 to 12.8	12.4 months Interval 8.8 to 14.9	13.8 months Interval 10.1 to 27.4	10.3 months Interval 6.5 to 14.1
PFS2; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets FAS	9.4 months Interval 8.2 to 10.9	10.4 months Interval 9.1 to 11.5	15.5 months Interval 12.5 to 24.5	12.9 months Interval 9.2 to 15.4

SECONDARY outcome

Timeframe: Months 12, 18 and 24

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). bTMB ≥20 mut/Mb, bTMB ≥16 mut/Mb and bTMB ≥12 mut/Mb analysis sets included the subset of participants in FAS whose bTMB status was ≥20 mut/Mb, ≥16 mut/Mb and ≥12 mut/Mb, respectively at baseline as defined by the GuardantOMNI CDx assay.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=143 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=138 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 12: bTMB ≥20 mut/Mb analysis set	49.3 percentage of participants Interval 37.1 to 60.4	40.8 percentage of participants Interval 28.3 to 52.9	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 12: bTMB ≥16 mut/Mb analysis set	50.5 percentage of participants Interval 40.0 to 60.2	48.9 percentage of participants Interval 38.2 to 58.8	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 12: bTMB ≥12 mut/Mb analysis set	46.9 percentage of participants Interval 38.5 to 54.8	44.6 percentage of participants Interval 36.1 to 52.7	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 18: bTMB ≥20 mut/Mb analysis set	36.2 percentage of participants Interval 25.1 to 47.4	20.4 percentage of participants Interval 11.3 to 31.4	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 18: bTMB ≥16 mut/Mb analysis set	35.5 percentage of participants Interval 25.9 to 45.1	28.5 percentage of participants Interval 19.5 to 38.1	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 18: bTMB ≥12 mut/Mb analysis set	29.4 percentage of participants Interval 22.1 to 36.9	27.8 percentage of participants Interval 20.6 to 35.4	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 24: bTMB ≥20 mut/Mb analysis set	26.1 percentage of participants Interval 16.4 to 36.8	13.6 percentage of participants Interval 6.4 to 23.6	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 24: bTMB ≥16 mut/Mb analysis set	24.0 percentage of participants Interval 15.8 to 33.2	18.2 percentage of participants Interval 11.0 to 26.9	—	—
OS at Months 12, 18 and 24; Global Cohort: bTMB ≥20 Mut/Mb, bTMB ≥16 Mut/Mb, and bTMB ≥12 Mut/Mb Analysis Sets Month 24: bTMB ≥12 mut/Mb analysis set	21.3 percentage of participants Interval 15.0 to 28.4	19.0 percentage of participants Interval 12.9 to 26.0	—	—

SECONDARY outcome

Timeframe: Months 12, 18 and 24

Population: Participants included in PD-L1-negative NSCLC and FAS analysis sets are reported in this outcome measure.

The OS was defined as the time from the date of randomization until death due to any cause (ie, date of death or censoring - date of randomization + 1). PD-L1-negative analysis set included the subset of participants in FAS whose PD-L1 status was PD-L1-negative at baseline as defined by the Ventana SP263 PD-L1 Assay (ie, \<1% PD-L1-membrane expression in tumoral tissue). Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=413 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab n=78 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy n=82 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets Month 12: PD-L1-negative NSCLC analysis set	47.8 percentage of participants Interval 37.2 to 57.6	52.8 percentage of participants Interval 42.6 to 61.9	68.0 percentage of participants Interval 46.1 to 82.5	46.4 percentage of participants Interval 27.6 to 63.3
OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets Month 12: FAS	47.7 percentage of participants Interval 42.8 to 52.5	50.0 percentage of participants Interval 45.0 to 54.8	72.8 percentage of participants Interval 61.3 to 81.3	53.1 percentage of participants Interval 41.7 to 63.2
OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets Month 18: PD-L1-negative NSCLC analysis set	34.1 percentage of participants Interval 24.5 to 43.9	34.5 percentage of participants Interval 25.4 to 43.8	44.0 percentage of participants Interval 24.5 to 61.9	39.3 percentage of participants Interval 21.7 to 56.5
OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets Month 18: FAS	34.8 percentage of participants Interval 30.2 to 39.5	34.6 percentage of participants Interval 30.0 to 39.3	54.6 percentage of participants Interval 42.8 to 64.9	41.8 percentage of participants Interval 31.0 to 52.3
OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets Month 24: PD-L1-negative NSCLC analysis set	22.1 percentage of participants Interval 14.0 to 31.3	22.3 percentage of participants Interval 14.7 to 30.9	36.0 percentage of participants Interval 18.2 to 54.2	17.9 percentage of participants Interval 6.5 to 33.7
OS at Months 12, 18 and 24; Global and China Cohorts: PD-L1-Negative NSCLC and FAS Analysis Sets Month 24: FAS	25.7 percentage of participants Interval 21.6 to 30.1	23.4 percentage of participants Interval 19.4 to 27.7	44.2 percentage of participants Interval 32.9 to 54.8	30.4 percentage of participants Interval 20.7 to 40.6

SECONDARY outcome

Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12; pre-dose on Week 24 and at follow-up Month 3

Population: Global Cohort: The FAS included all randomized participants prior to the end of global recruitment. Any participants recruited in China, after global recruitment had ended, were not included in the FAS. China Cohort: The China FAS included all randomized participants in the China cohort and were used for all China only efficacy analyses.

Blood samples were collected to determine the serum concentration of durvalumab.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=78 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Serum Concentrations of Durvalumab Week 0: Pre-infusion	NA microgram per milliliter (µg/mL) Geometric Coefficient of Variation NA NA = Below LLOQ. The LLOQ = 0.05 µg/mL.	NA microgram per milliliter (µg/mL) Geometric Coefficient of Variation NA NA = Below lower limit of quantification (LLOQ). The LLOQ = 0.05 µg/mL.	—	—
Serum Concentrations of Durvalumab Week 0: End of infusion	418.6 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 74.8	392.7 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 48.9	—	—
Serum Concentrations of Durvalumab Week 12: Pre-infusion	77.5 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 138.1	72.4 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 55.0	—	—
Serum Concentrations of Durvalumab Week 12: End of infusion	434.3 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 105.6	448.9 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 40.0	—	—
Serum Concentrations of Durvalumab Week 24: Pre-infusion	108.8 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 95.7	85.6 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 93.9	—	—
Serum Concentrations of Durvalumab Follow-up Month 3	8.8 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 253.9	5.4 microgram per milliliter (µg/mL) Geometric Coefficient of Variation 351.7	—	—

SECONDARY outcome

Timeframe: Pre-dose and within 1 hour after end of infusion at Week 0 and 12, and at follow-up Month 3

Blood samples were collected to determine the serum concentration of tremelimumab.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=410 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=78 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Serum Concentrations of Tremelimumab Week 12: Pre-infusion	3.4 µg/mL Geometric Coefficient of Variation 99.6	3.3 µg/mL Geometric Coefficient of Variation 64.6	—	—
Serum Concentrations of Tremelimumab Week 12: End of infusion	20.8 µg/mL Geometric Coefficient of Variation 67.4	23.2 µg/mL Geometric Coefficient of Variation 43.4	—	—
Serum Concentrations of Tremelimumab Week 0: Pre-infusion	NA µg/mL Geometric Coefficient of Variation NA NA = Below LLOQ. The LLOQ = 0.05 µg/mL.	NA µg/mL Geometric Coefficient of Variation NA NA = Below LLOQ. The LLOQ = 0.05 µg/mL.	—	—
Serum Concentrations of Tremelimumab Week 0: End of infusion	20.3 µg/mL Geometric Coefficient of Variation 38.7	18.4 µg/mL Geometric Coefficient of Variation 43.3	—	—
Serum Concentrations of Tremelimumab Follow-up Month 3	NA µg/mL Geometric Coefficient of Variation NA NA = Below LLOQ. The LLOQ = 0.05 µg/mL.	NA µg/mL Geometric Coefficient of Variation NA NA = Below LLOQ. The LLOQ = 0.05 µg/mL.	—	—

SECONDARY outcome

Timeframe: At Weeks 0, 12, and 24; 3 and 6 months after last dose of study treatment.

Blood samples were measured for the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to \>=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=266 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=61 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at any visit (ADA prevalence)	26 Participants	1 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-emergent ADA positive (ADA incidence)	12 Participants	1 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-boosted ADA	0 Participants	0 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-induced ADA (positive post-baseline only)	12 Participants	1 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive post-baseline and positive at baseline	1 Participants	0 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Persistent positive	11 Participants	1 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Transient positive	2 Participants	0 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab nAb positive at any visit	3 Participants	0 Participants	—	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at baseline and not detected post-baseline	13 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: At Weeks 0 and 12; 3 and 6 months after last dose of study treatment.

Blood samples were measured for the presence of ADAs and ADA-nAb for tremelimumab using validated assays. ADA prevalence is defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Treatment-emergent ADA is defined as the sum of treatment-induced ADA and treatment-boosted ADA. ADA incidence is the percentage of participants who were treatment-emergent ADA-positive. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to \>=4 fold during the study period. Persistently positive is defined as having at least 2 post baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive is defined as having at least 1 post baseline ADA positive measurement and not fulfilling the conditions for persistently positive.

Outcome measures

Outcome measures
Measure	Global: Durvalumab + Tremelimumab n=265 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	Global: SoC Chemotherapy n=61 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	China: Durvalumab + Tremelimumab Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	China: SoC Chemotherapy Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).
Number of Participants With ADA Response to Tremelimumab ADA positive at any visit (ADA prevalence)	49 Participants	2 Participants	—	—
Number of Participants With ADA Response to Tremelimumab Treatment-emergent ADA positive (ADA incidence)	37 Participants	1 Participants	—	—
Number of Participants With ADA Response to Tremelimumab Treatment-boosted ADA	1 Participants	0 Participants	—	—
Number of Participants With ADA Response to Tremelimumab Treatment-induced ADA (positive post-baseline only)	36 Participants	1 Participants	—	—
Number of Participants With ADA Response to Tremelimumab ADA positive post-baseline and positive at baseline	4 Participants	1 Participants	—	—
Number of Participants With ADA Response to Tremelimumab Persistent positive	29 Participants	0 Participants	—	—
Number of Participants With ADA Response to Tremelimumab Transient positive	11 Participants	2 Participants	—	—
Number of Participants With ADA Response to Tremelimumab nAb positive at any visit	33 Participants	0 Participants	—	—
Number of Participants With ADA Response to Tremelimumab ADA positive at baseline and not detected post-baseline	9 Participants	0 Participants	—	—

Adverse Events

Global: Durvalumab + Tremelimumab

Serious events: 193 serious events

Other events: 310 other events

Deaths: 328 deaths

Global: SoC Chemotherapy

Serious events: 112 serious events

Other events: 349 other events

Deaths: 329 deaths

China: Durvalumab + Tremelimumab

Serious events: 32 serious events

Other events: 73 other events

Deaths: 50 deaths

China: SoC Chemotherapy

Serious events: 22 serious events

Other events: 77 other events

Deaths: 62 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	All Participants: Durvalumab + Tremelimumab n=474 Participants Participants received durvalumab 20 mg/kg and tremelimumab 1 mg/kg IV infusion Q4W in combination for up to 4 doses/cycles. Participants then continued to receive durvalumab 20 mg/kg Q4W, starting on Week 16 until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met.	All Participants: SoC Chemotherapy n=479 Participants Participants received 1 of the following IV infusion treatment combinations on Day 1 of each 21-day cycle for 4 to 6 cycles or until objective PD, initiation of alternative anticancer therapy, unacceptable toxicity, withdrawal of consent, or specific treatment discontinuation criteria were met. 1. Paclitaxel 200 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. 2. Gemcitabine 1000 or 1250 mg/m\^2 and cisplatin 75 or 80 mg/m\^2. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 3. Gemcitabine 1000 or 1250 mg/m\^2 and carboplatin AUC 5 or 6 mg\min/mL. Additional dose of gemcitabine 1000 or 1250 mg/m\^2 on Day 8 of each cycle (For squamous participants only). 4. Pemetrexed 500 mg/m\^2 and cisplatin 75 mg/m\^2 (For non-squamous participants only; pemetrexed maintenance dose was permitted). 5. Pemetrexed 500 mg/m\^2 and carboplatin AUC 5 or 6 mg\*min/mL (For non-squamous participants only; pemetrexed maintenance dose was permitted).	Total n=953 Participants Total of all reporting groups
Age, Customized All participants · <=18 years	0 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized All participants · Between 18 and 65 years	278 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	244 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	522 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized All participants · >=65 years	196 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	235 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	431 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized Global cohort · <=18 years	0 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized Global cohort · Between 18 and 65 years	233 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	203 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	436 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized Global cohort · >=65 years	177 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	210 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	387 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized China cohort · <=18 years	0 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized China cohort · Between 18 and 65 years	53 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	51 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	104 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Age, Customized China cohort · >=65 years	25 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	31 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	56 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Sex: Female, Male All participants · Female	127 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	129 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	256 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Sex: Female, Male All participants · Male	347 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	350 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	697 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Sex: Female, Male Global cohort · Female	113 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	108 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	221 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Sex: Female, Male Global cohort · Male	297 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	305 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	602 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Sex: Female, Male China cohort · Female	18 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	25 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	43 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Sex: Female, Male China cohort · Male	60 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	57 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	117 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · White	307 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	289 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	596 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · Black or African American	3 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	7 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	10 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · Asian	150 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	165 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	315 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · Hispanic or Latino	0 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · American Indian or Alaska Native	10 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	12 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	22 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · Other	3 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	4 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	7 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · Missing	1 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	2 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	3 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · White	307 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	289 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	596 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · Black or African American	3 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	7 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	10 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · Asian	86 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	99 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	185 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · American Indian or Alaska Native	10 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	12 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	22 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · Other	3 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	4 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	7 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · Missing	1 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	2 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	3 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · White	0 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · Black or African American	0 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · Asian	78 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	82 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	160 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · American Indian or Alaska Native	0 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · Other	0 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · Missing	0 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	0 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · Hispanic or Latino	50 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	48 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	98 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized All participants · Not Hispanic or Latino	423 Participants n=474 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	429 Participants n=479 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	852 Participants n=953 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · Hispanic or Latino	50 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	48 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	98 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized Global cohort · Not Hispanic or Latino	359 Participants n=410 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	363 Participants n=413 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	722 Participants n=823 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.
Race/Ethnicity, Customized China cohort · Not Hispanic or Latino	78 Participants n=78 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	82 Participants n=82 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.	160 Participants n=160 Participants • Baseline data is presented for all participants, as well as separately for the Global and China cohorts.