Trial Outcomes & Findings for Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer (NCT NCT03519971)

NCT ID: NCT03519971

Last Updated: 2025-10-28

Results Overview

The PFS per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) using blinded independent central review (BICR) 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 therapy or received another anti-cancer therapy prior to progression. The PD was defined as at least a 20% increase in the sum of diameters of target lesions. Median PFS was calculated using the Kaplan-Meier technique.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

328 participants

Primary outcome timeframe

Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).

Results posted on

2025-10-28

Participant Flow

This Phase III double-blind, placebo-controlled study was conducted in participants with locally advanced, unresectable Stage III non-small cell lung cancer (NSCLC) at 87 study centers in North and South America, Europe, and Asia Pacific. The results are reported for analysis with assessment until data cut-off (DCO) date of 07 September 2023.

The study had a screening period (up to 28 days), followed by a treatment and follow-up period (up to 1960 days). A total of 328 participants were randomized in a 2:1 ratio to receive durvalumab + standard of care (SoC) concurrent chemoradiotherapy (cCRT) group or placebo + SoC cCRT group.

Participant milestones

Participant milestones
Measure	Durvalumab + SoC CRT Participants received durvalumab 1500 milligram (mg) intravenous (IV) infusion every 4 weeks (Q4W) until progressive disease (PD) or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/square meter (m\^2) on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin area under the plasma drug concentration-time curve (AUC) 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 every 3 weeks (Q3W) given either as 1 induction cycle prior to initiation of radiation therapy (RT) or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT) was delivered using external beam radiation therapy (EBRT) of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Overall Study STARTED	219	109
Overall Study Received Treatment	218	109
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	219	109

Reasons for withdrawal

Reasons for withdrawal
Measure	Durvalumab + SoC CRT Participants received durvalumab 1500 milligram (mg) intravenous (IV) infusion every 4 weeks (Q4W) until progressive disease (PD) or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/square meter (m\^2) on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin area under the plasma drug concentration-time curve (AUC) 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 every 3 weeks (Q3W) given either as 1 induction cycle prior to initiation of radiation therapy (RT) or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3-dimensional conformal radiotherapy (3DCRT) or intensity-modulated radiation therapy (IMRT) was delivered using external beam radiation therapy (EBRT) of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Overall Study Death	142	69
Overall Study Lost to Follow-up	0	1
Overall Study Ongoing treatment and in follow-up at data cut off	73	37
Overall Study Withdrawal by Subject	3	2
Overall Study Other	1	0

Baseline Characteristics

Study of Durvalumab Given With Chemoradiation Therapy in Patients With Unresectable Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Total n=328 Participants Total of all reporting groups
Age, Continuous	62.8 years STANDARD_DEVIATION 8.96 • n=5 Participants	62.4 years STANDARD_DEVIATION 9.50 • n=7 Participants	62.6 years STANDARD_DEVIATION 9.13 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants	29 Participants n=7 Participants	82 Participants n=5 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	80 Participants n=7 Participants	246 Participants n=5 Participants
Race/Ethnicity, Customized White	141 Participants n=5 Participants	62 Participants n=7 Participants	203 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	65 Participants n=5 Participants	39 Participants n=7 Participants	104 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	33 Participants n=5 Participants	21 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	186 Participants n=5 Participants	88 Participants n=7 Participants	274 Participants n=5 Participants

PRIMARY outcome

Timeframe: Tumour scans performed at screening, 16 weeks ±1 week after randomization, then every 8 weeks ±1 week up to 48 weeks, and then every 12 weeks ±1 week thereafter until confirmed PD. Assessed up to the DCO date (a maximum of approximately 1988 days).

Population: The FAS included all randomized participants.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Progression-Free Survival (PFS)	13.8 months Interval 9.5 to 16.9	9.4 months Interval 7.5 to 16.6

SECONDARY outcome

Population: The FAS included all randomized participants.

The ORR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of complete response (CR) or partial response (PR) based on all participants in the FAS. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Objective Response Rate (ORR)	60.7 percentage of participants Interval 53.9 to 67.2	60.6 percentage of participants Interval 50.7 to 69.8

SECONDARY outcome

Timeframe: From screening until confirmed PD, assessed up to the DCO date (a maximum of approximately 1988 days).

Population: The FAS included all randomized participants.

The OS was defined as the time from the date of randomization until death due to any cause regardless of whether the participant withdrew from randomized therapy or received another anti-cancer therapy. Median OS was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Overall Survival (OS)	36.4 months Interval 26.2 to 45.6	29.5 months Interval 23.2 to 45.1

SECONDARY outcome

Timeframe: Month 24

Population: The FAS included all randomized participants.

The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months. Median OS24 was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Percentage of Participants Alive at 24 Months From Randomization (OS24)	58.4 percentage of participants Interval 51.6 to 64.7	59.5 percentage of participants Interval 49.6 to 68.2

SECONDARY outcome

Population: The FAS included all randomized participants.

The CRR per RECIST 1.1 using BICR was defined as the percentage of participants with a confirmed response of CR. The CR was defined as disappearance of all target lesions since baseline.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Complete Response Rate (CRR)	1.8 percentage of participants Interval 0.5 to 4.6	1.8 percentage of participants Interval 0.2 to 6.5

SECONDARY outcome

Population: The FAS included all randomized participants. Only participants with objective response are analyzed.

The DoR per RECIST 1.1 using BICR was defined as the time from the date of first documented response (which was subsequently confirmed) until the first date of documented progression or death in the absence of PD. The CR was defined as disappearance of all target lesions since baseline. The PR was defined as at least a 30% decrease in the sum of the diameters of target lesions. The DoR was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=133 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=66 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Duration of Response (DoR)	30.7 months Interval 8.8 to Upper limit of inter-quartile range could not be calculated as it was not reached as there were an insufficient number of participants with events.	18.6 months Interval 7.4 to 56.5

SECONDARY outcome

Timeframe: Week 24

Population: The FAS included all randomized participants.

The DCR at 24 weeks per RECIST 1.1 using BICR was defined as the percentage of participants who had a best objective response of CR or PR in the first 25 weeks (to allow for late assessment within the assessment window) or who had stable disease for \>= 23 weeks after randomization (to allow for an early assessment within the ± 1 week assessment window).

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Disease Control Rate (DCR)	65.8 percentage of participants	65.1 percentage of participants

SECONDARY outcome

Population: The FAS included all randomized participants.

The TTDM per RECIST 1.1 using BICR was defined as the time from the date of randomization until the first date of distant metastasis or death in the absence of distant metastasis. Distant metastasis was defined as any new lesion that was outside the radiation field according to RECIST 1.1 or proven by biopsy.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Time to Death or Distant Metastasis (TTDM)	51.0 months Interval 25.0 to Upper limit of inter-quartile range could not be calculated as it was not reached as there were an insufficient number of participants with events.	46.3 months Interval 16.6 to Upper limit of inter-quartile range could not be calculated as it was not reached as there were an insufficient number of participants with events.

SECONDARY outcome

Population: The FAS included all randomized participants.

The PFS2 was defined as the time from the date of randomization to the earliest of the progression event (subsequent to that used for the primary variable PFS per Investigator assessment) or death. The date of the second progression was recorded by the Investigator and defined according to local standard clinical practice and could have involved any of objective radiological, symptomatic progression, or death. Median PFS2 was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=109 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Time From Randomization to Second Progression (PFS2)	27.8 months Interval 21.8 to 35.8	22.0 months Interval 16.2 to 28.0

SECONDARY outcome

Timeframe: End of infusion on Week 0, pre-infusion on Weeks 4 and 12, and Month 3 follow-up

Population: The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of durvalumab or matching placebo per protocol, for whom any post-dose data were available and did not violate or deviate from the protocol in ways that would significantly affect the PK analyses. Only participants analyzed at specific timepoint are reported.

Blood samples were collected to determine the concentration of durvalumab.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=190 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Serum Concentration of Durvalumab Week 0: End of infusion	452.21 microgram per milliliter Geometric Coefficient of Variation 78.94	—
Serum Concentration of Durvalumab Week 4: Pre-infusion	82.02 microgram per milliliter Geometric Coefficient of Variation 80.85	—
Serum Concentration of Durvalumab Week 12: Pre-infusion	123.39 microgram per milliliter Geometric Coefficient of Variation 163.20	—
Serum Concentration of Durvalumab Month 3 Follow-up	15.79 microgram per milliliter Geometric Coefficient of Variation 243.41	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1, 2 and 4

Population: The ADA analysis set included all participants who had non-missing baseline ADA and at least 1 non-missing post-baseline ADA result.

Blood samples were collected to determine the presence of ADAs and ADA-neutralizing antibodies (nAb) for durvalumab using validated assays. ADA prevalence was defined as the number of participants with positive ADA result at any time, baseline or post-baseline. ADA incidence was defined as either treatment-induced (post-baseline ADA positive only) or treatment-boosted ADA (baseline positive ADA titer that was boosted to \>= 4-fold during the study period). Treatment-induced ADA was defined as ADA positive only post-baseline and not detected at baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive assessments with at least 16 weeks between the first and last positive assessment, or ADA positive at the last post-baseline assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive assessment without fulfilling the conditions for persistently positive.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=199 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at any visit (ADA prevalence)	20 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-emergent ADA positive (ADA incidence)	8 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at both baseline and post-baseline	2 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-induced ADA	8 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at baseline only	10 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-boosted ADA	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Persistent positive	6 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Transient positive	4 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab nAb positive at any visit	1 Participants	—

SECONDARY outcome

Timeframe: At screening, 2, 4, 6, 8, 12, 16, and 20 weeks after randomization, then every 8 weeks ±1 week up to 52 weeks, and then every 12 weeks ±1 week thereafter until PFS2. Assessed up to 12 months.

Population: The FAS included all randomized participants. Only participants analyzed at baseline through Month 12 are reported.

Patient reported outcomes for 5 disease related symptoms was assessed using the EORTC QLQ-Core 30 (C30) items questionnaire (fatigue and appetite loss) and the EORTC QLQ-Lung Cancer module 13 (LC13) (dysponea, cough and chest pain). An outcome variable consisting of a total score from 0 to 100 was derived for each of the symptom scales/symptom items, the functional scales, and the global health status scale with higher scores on the global health status/quality of life (QoL) and functioning scales representing better health status/function, but higher scores on symptom scales/items representing greater symptom severity. An improvement in symptoms were indicated by a negative change in score from baseline. A positive change in score from baseline indicated a deterioration of symptoms. A minimum clinically meaningful change was defined as a change from baseline of \>=10.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=196 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=95 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months EORTC QLQ-C30: Global health status/QoL	-0.5 units on a scale Interval -2.3 to 1.4	0.2 units on a scale Interval -2.4 to 2.8
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months EORTC QLQ-C30: Fatigue symptoms	1.3 units on a scale Interval -0.9 to 3.4	0.3 units on a scale Interval -2.8 to 3.3
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months EORTC QLQ-C30: Physical functioning	-1.4 units on a scale Interval -3.0 to 0.2	-0.8 units on a scale Interval -3.1 to 1.4
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months EORTC QLQ-C30: Appetite loss symptoms	3.0 units on a scale Interval 0.9 to 5.2	0.3 units on a scale Interval -2.7 to 3.3
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months EORTC QLQ-LC13: Dyspnoea symptoms	1.1 units on a scale Interval -1.0 to 3.1	-1.3 units on a scale Interval -4.2 to 1.6
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months EORTC QLQ-LC13: Cough symptoms	-6.1 units on a scale Interval -8.6 to -3.6	-6.5 units on a scale Interval -10.0 to -2.9
Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Average Over 12 Months EORTC QLQ-LC13: Pain in chest symptoms	-1.9 units on a scale Interval -4.2 to 0.4	-0.8 units on a scale Interval -3.9 to 2.4

SECONDARY outcome

Timeframe: From time of signature of informed consent up to 90 days after last dose of study treatment or up to the date of initiation of the first subsequent therapy, whichever occurs first, approximately 1988 days.

Population: The Safety analysis set included all participants who received at least 1 dose of randomized treatment.

An AE is the development of any untoward medical occurrence in a participant or clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A SAE is an AE occurring during any study phase, that fulfils 1 or more of the following criteria: death, life-threatening, in-participant hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital abnormality or birth defect, and an important medical event that may jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AEs leading to discontinuation of study treatment were those with action taken was 'Drug Permanently Discontinued' for any study treatment.

Outcome measures

Outcome measures
Measure	Durvalumab + SoC CRT n=219 Participants Participants received durvalumab 1500 mg IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).	Placebo + SoC CRT n=108 Participants Participants received placebo matching with durvalumab IV infusion Q4W until PD or specific treatment discontinuation criteria were met. Participants received SOC CRT, consisting of concurrent radiotherapy and IV infusion of 1 of the following chemotherapy regimens. 1. Cisplatin + Etoposide: Cisplatin 50 mg/m\^2 on Days 1 and 8 and etoposide 50 mg/m\^2 on Days 1 to 5 Q4W of each 28-day cycle for 2 cycles plus 1 additional optional induction cycle. 2. Carboplatin + Paclitaxel: Carboplatin AUC 2 and paclitaxel 40-50 mg/m\^2 on Day 1 weekly basis for 6 weeks. Optional: Carboplatin AUC 5-6 and paclitaxel 175-200 mg/m\^2 Q3W given either as 1 induction cycle prior to initiation of RT or as 1-2 consolidation cycles after completion of RT. 3. Cisplatin + Pemetrexed: Cisplatin 75 mg/m\^2 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 3 cycles plus 1 additional optional induction cycle. 4. Carboplatin + Pemetrexed: Carboplatin AUC 5 and pemetrexed 500 mg/m\^2 on Day 1 of each 21-day cycle for 4 cycles. Radiation: Either standard 3DCRT or IMRT was delivered using EBRT of 5 fractions per week for \~6 weeks (± 3 days).
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AE	98.6 percentage of participants	100.0 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any SAE	47.0 percentage of participants	51.9 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any AE leading to discontinuation of treatment	34.7 percentage of participants	19.4 percentage of participants
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Any immune-mediated AE	48.9 percentage of participants	28.7 percentage of participants

Adverse Events

Durvalumab + SoC CRT

Serious events: 103 serious events

Other events: 209 other events

Deaths: 142 deaths

Placebo + SoC CRT

Serious events: 56 serious events

Other events: 106 other events

Deaths: 69 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