Trial Outcomes & Findings for A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients (NCT NCT03706690)

Last Updated: 2025-11-10

Results Overview

The PFS per Response Evaluation Criteria in Solid Tumors 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 disease progression (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 (TLs) and an absolute increase of \>=5 millimeters (mm), taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

407 participants

Primary outcome timeframe

Tumor scans performed at screening, 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 23-Jun-2024 (a maximum of approximately 2035 days)

Results posted on

2025-11-10

Participant Flow

This Phase III double-blind, placebo-controlled study was conducted at 82 investigational sites across 10 countries in participants with locally advanced, unresectable, non-small cell lung cancer (Stage III), who had not progressed following definitive, platinum-based, chemoradiation therapy (CRT).

The study consisted of a screening period (Day -84 to Day -1), randomization (Day 1), treatment period commencing on Day 1 and a survival follow-up period until protocol-specified discontinuation criteria were met. A total of 407 participants were randomized in a 2:1 ratio to receive either durvalumab or placebo in this study. Results are presented up to data cut-off (DCO) date of 23-Jun-2024.

Participant milestones

Participant milestones
Measure	Durvalumab Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion on Day 1 and every 4 weeks (Q4W) thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Study STARTED	272	135
Overall Study Participants Who Received Treatment	271	134
Overall Study Intent-to-treat (ITT) Set	272	135
Overall Study Modified Intent-to-treat (mITT) Set	252	129
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	272	135

Reasons for withdrawal

Reasons for withdrawal
Measure	Durvalumab Participants received durvalumab 1500 milligram (mg) via intravenous (IV) infusion on Day 1 and every 4 weeks (Q4W) thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Study Withdrawal by Subject	8	8
Overall Study Death	143	75
Overall Study Ongoing at DCO	121	52

Baseline Characteristics

A Study of Durvalumab as Consolidation Therapy in Non-Small Cell Lung Cancer Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab n=272 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=135 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Total n=407 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 8.33 • n=5 Participants	61.9 years STANDARD_DEVIATION 7.96 • n=20 Participants	61.7 years STANDARD_DEVIATION 8.20 • n=40 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	18 Participants n=20 Participants	43 Participants n=40 Participants
Sex: Female, Male Male	247 Participants n=5 Participants	117 Participants n=20 Participants	364 Participants n=40 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	0 Participants n=20 Participants	5 Participants n=40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	267 Participants n=5 Participants	135 Participants n=20 Participants	402 Participants n=40 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Asian	197 Participants n=5 Participants	97 Participants n=20 Participants	294 Participants n=40 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) White	75 Participants n=5 Participants	38 Participants n=20 Participants	113 Participants n=40 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants

PRIMARY outcome

Timeframe: Tumor scans performed at screening, 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 23-Jun-2024 (a maximum of approximately 2035 days)

Population: The mITT set included all randomized participants who were without sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Outcome measures

Outcome measures
Measure	Durvalumab n=252 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=129 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Progression-Free Survival (PFS) (Modified Intent-to-Treat [mITT] Set)	14.0 months Interval 10.9 to 18.0	6.5 months Interval 5.4 to 13.8

SECONDARY outcome

Timeframe: Assessed up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days)

Population: Analysis was performed on the mITT and ITT set. The mITT set included all randomized participants who were without sensitizing EGFR mutations or ALK rearrangements. The ITT set 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 n=272 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=135 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Overall Survival (OS) mITT set	38.3 months Interval 28.9 to 42.8	32.5 months Interval 20.6 to 40.4
Overall Survival (OS) ITT set	38.4 months Interval 29.0 to 42.9	32.5 months Interval 20.6 to 40.4

SECONDARY outcome

Population: The ITT set included all randomized participants.

The PFS per RECIST 1.1 using 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 and an absolute increase of \>=5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. Median PFS was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab n=272 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=135 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Progression-Free Survival (PFS) (Intent-to-Treat [ITT] Set)	14.1 months Interval 10.9 to 18.2	7.4 months Interval 5.5 to 13.8

SECONDARY outcome

Timeframe: Month 24

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. The OS24 was defined as the Kaplan-Meier estimate of OS at 24 months after randomization.

Outcome measures

Outcome measures
Measure	Durvalumab n=272 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=135 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Percentage of Participants Alive at 24 Months (OS24) mITT set	60.7 percentage of participants Interval 54.2 to 66.5	54.4 percentage of participants Interval 45.2 to 62.7
Percentage of Participants Alive at 24 Months (OS24) ITT set	60.8 percentage of participants Interval 54.7 to 66.5	54.6 percentage of participants Interval 45.6 to 62.8

SECONDARY outcome

The ORR per RECIST 1.1 using BICR was defined as the percentage of participants with at least 1 visit response of complete response (CR) or partial response (PR) based on all participants in the subset of the analysis population including only those participants with measurable disease at baseline per BICR. The CR was defined as disappearance of all TLs since baseline. Any pathological lymph nodes selected as TLs must have a reduction in short axis to \<10 mm. The PR was defined as at least a 30% decrease in the sum of the diameters of TLs, taking as reference the baseline sum of diameters as long as criteria for PD are not met.

Outcome measures

Outcome measures
Measure	Durvalumab n=240 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=127 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Objective Response Rate (ORR) mITT set	27.6 percentage of participants	20.7 percentage of participants
Objective Response Rate (ORR) ITT set	27.1 percentage of participants	19.7 percentage of participants

SECONDARY outcome

The DoR per RECIST 1.1 using BICR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of PD. PD was defined as at least a 20% increase in the sum of diameters of target lesions and an absolute increase of \>=5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. The DoR was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab n=65 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=25 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Duration of Response (DoR) mITT set	NA months Interval 16.6 to NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at DCO date.	37.6 months Interval 5.4 to NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.
Duration of Response (DoR) ITT set	NA months Interval 20.7 to NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at DCO date.	37.6 months Interval 5.4 to NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.

SECONDARY outcome

Timeframe: Months 12 and 18

The PFS per RECIST 1.1 using 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 and an absolute increase of \>=5 mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters. The PFS12 and PFS18 were defined as the Kaplan-Meier estimate of PFS per RECIST 1.1 as assessed by the Investigator at 12 and 18 months, respectively and both were obtained using the algorithm for the RECIST 1.1 site Investigator tumor data.

Outcome measures

Outcome measures
Measure	Durvalumab n=272 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=135 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Percentage of Participants Alive and Progression-Free at 12 and 18 Months (PFS12 and PFS18) PFS12, mITT set	53.6 percentage of participants Interval 47.0 to 59.7	42.7 percentage of participants Interval 33.8 to 51.4
Percentage of Participants Alive and Progression-Free at 12 and 18 Months (PFS12 and PFS18) PFS18, mITT set	43.4 percentage of participants Interval 36.9 to 49.7	34.1 percentage of participants Interval 25.6 to 42.8
Percentage of Participants Alive and Progression-Free at 12 and 18 Months (PFS12 and PFS18) PFS12, ITT set	54.2 percentage of participants Interval 47.9 to 60.1	42.5 percentage of participants Interval 33.8 to 51.0
Percentage of Participants Alive and Progression-Free at 12 and 18 Months (PFS12 and PFS18) PFS18, ITT set	44.2 percentage of participants Interval 37.9 to 50.3	33.4 percentage of participants Interval 25.1 to 41.9

SECONDARY outcome

PFS2 was defined as the time from the date of randomization to the earliest of the progression event subsequent to first subsequent therapy, 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 imaging, symptomatic progression, or death. Median time to PFS2 was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab n=272 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=135 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Time From Randomization to Second Progression (PFS2) mITT set	26.4 months Interval 22.1 to 36.0	19.5 months Interval 14.7 to 28.9
Time From Randomization to Second Progression (PFS2) ITT set	26.2 months Interval 22.0 to 34.8	19.5 months Interval 14.3 to 28.9

SECONDARY outcome

TTDM as 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 of the radiation field according to RECIST 1.1. Median TTDM was calculated using the Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Durvalumab n=272 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=135 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Time to Death or Distant Metastases (TTDM) mITT set	42.6 months Interval 33.2 to NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.	NA months Interval 20.3 to NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at DCO date.
Time to Death or Distant Metastases (TTDM) ITT set	42.6 months Interval 33.2 to NA indicates that upper limit of CI was not estimable due to insufficient number of participants with events at DCO date.	NA months Interval 20.3 to NA indicates that median and upper limit of CI were not estimable due to insufficient number of participants with events at DCO date.

SECONDARY outcome

Timeframe: End of infusion on Cycle 1 Day 1, pre-infusion on Cycles 2 and 4 Day 1 and Month 3 follow-up (each cycle=28 days)

Population: The Pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of durvalumab as per protocol for whom any post-dose data were available and who did not violate/deviate from protocol in ways that would significantly have affected the PK analyses. Only those participants with data collected at specified timepoints are reported.

Blood samples were collected to determine the concentration of durvalumab.

Outcome measures

Outcome measures
Measure	Durvalumab n=249 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Serum Concentration of Durvalumab Cycle 2 Day 1	93929.182 nanogram/milliliter Standard Deviation 86188.4708	—
Serum Concentration of Durvalumab Cycle 4 Day 1	138752.016 nanogram/milliliter Standard Deviation 73792.7522	—
Serum Concentration of Durvalumab Month 3 follow-up	40303.562 nanogram/milliliter Standard Deviation 47725.6327	—
Serum Concentration of Durvalumab Cycle 1 Day 1	511415.541 nanogram/milliliter Standard Deviation 222137.0134	—

SECONDARY outcome

Timeframe: Pre-dose on Day 1 of Cycles 1, 2 and 4 (each cycle=28 days)

Population: 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 n=255 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at any visit (ADA prevalence)	9 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-emergent ADA positive (ADA incidence)	3 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at both baseline and post-baseline	1 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Treatment-induced ADA	3 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab ADA positive at baseline only	5 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 Persistently positive	0 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab Transiently positive	4 Participants	—
Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab nAb positive	2 Participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 132

Patient reported outcomes for 5 disease related symptoms was assessed using EORTC QLQ-Core 30 (C30) items questionnaire (fatigue, appetite loss) and EORTC QLQ-Lung Cancer module 13 (LC13) (dyspnoea, cough and pain in chest).An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales/symptom items, functional scales, and global health status scale with higher scores on global health status/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 change from baseline of \>=10. Change from baseline in C30: global health status/QoL, physical functioning, fatigue, appetite loss and LC13: dyspnoea, cough and pain in chest are presented.

Outcome measures

Outcome measures
Measure	Durvalumab n=63 Participants Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=22 Participants Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 mITT set: EORTC QLQ-C30: Global health status/QoL	78.95 units on a scale Standard Deviation 13.918	74.21 units on a scale Standard Deviation 17.261
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 mITT set: EORTC QLQ-C30: Physical functioning	90.76 units on a scale Standard Deviation 10.216	92.38 units on a scale Standard Deviation 11.012
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 mITT set: EORTC QLQ-C30: Fatigue symptom	10.14 units on a scale Standard Deviation 13.814	13.76 units on a scale Standard Deviation 18.225
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 mITT set: EORTC QLQ-C30: Appetite loss symptom	5.85 units on a scale Standard Deviation 12.791	3.17 units on a scale Standard Deviation 10.026
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 mITT set: EORTC QLQ-LC13: Dyspnoea symptom	15.98 units on a scale Standard Deviation 14.998	11.11 units on a scale Standard Deviation 12.172
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 mITT set: EORTC QLQ-LC13: Cough symptom	16.37 units on a scale Standard Deviation 21.009	22.22 units on a scale Standard Deviation 21.943
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 mITT set: EORTC QLQ-LC13: Pain in chest symptom	9.94 units on a scale Standard Deviation 16.625	6.35 units on a scale Standard Deviation 13.412
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 ITT set: EORTC QLQ-C30: Global health status/QoL	78.70 units on a scale Standard Deviation 13.943	74.24 units on a scale Standard Deviation 16.846
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 ITT set: EORTC QLQ-C30: Physical functioning	90.79 units on a scale Standard Deviation 10.120	92.73 units on a scale Standard Deviation 10.869
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 ITT set: EORTC QLQ-C30: Fatigue symptom	10.93 units on a scale Standard Deviation 14.866	13.13 units on a scale Standard Deviation 18.026
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 ITT set: EORTC QLQ-C30: Appetite loss symptom	5.29 units on a scale Standard Deviation 12.279	3.03 units on a scale Standard Deviation 9.808
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 ITT set: EORTC QLQ-LC13: Dyspnoea symptom	15.17 units on a scale Standard Deviation 14.974	10.61 units on a scale Standard Deviation 12.112
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 ITT set: EORTC QLQ-LC13: Cough symptom	15.87 units on a scale Standard Deviation 21.467	21.21 units on a scale Standard Deviation 21.932
Change From Baseline in Patient-Reported Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at Week 132 ITT set: EORTC QLQ-LC13: Pain in chest symptom	10.05 units on a scale Standard Deviation 17.592	7.58 units on a scale Standard Deviation 14.298

SECONDARY outcome

Timeframe: Up to 9 years

Blood samples will be collected for clinical biomarker testing and a tumor specimen will be collected as per tumor specimen collection requirements. The specimen will be evaluated by immunohistochemistry to determine the expression of tumor specific antigens and immune markers. The PD-L1 is a biomarker and data for number of participants with its positive status will be presented.

Outcome measures

Outcome data not reported

Adverse Events

Durvalumab

Serious events: 104 serious events

Other events: 223 other events

Deaths: 143 deaths

Placebo

Serious events: 45 serious events

Other events: 94 other events

Deaths: 75 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	Durvalumab n=271 participants at risk Participants received durvalumab 1500 mg via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.	Placebo n=134 participants at risk Participants received placebo matched to durvalumab via IV infusion on Day 1 and Q4W thereafter until confirmed radiological progression, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.
General disorders Fatigue	6.6% 18/271 • Number of events 20 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	3.0% 4/134 • Number of events 4 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
General disorders Pyrexia	5.2% 14/271 • Number of events 19 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	3.7% 5/134 • Number of events 7 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Hepatobiliary disorders Hepatic function abnormal	5.2% 14/271 • Number of events 15 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	1.5% 2/134 • Number of events 2 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Infections and infestations COVID-19	11.1% 30/271 • Number of events 31 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	9.7% 13/134 • Number of events 13 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Infections and infestations Herpes zoster	2.6% 7/271 • Number of events 8 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	6.7% 9/134 • Number of events 9 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Infections and infestations Pneumonia	12.9% 35/271 • Number of events 37 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	8.2% 11/134 • Number of events 11 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Blood and lymphatic system disorders Anaemia	15.1% 41/271 • Number of events 57 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	14.9% 20/134 • Number of events 27 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Infections and infestations Upper respiratory tract infection	11.1% 30/271 • Number of events 40 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	11.2% 15/134 • Number of events 20 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Injury, poisoning and procedural complications Radiation pneumonitis	19.2% 52/271 • Number of events 53 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	20.1% 27/134 • Number of events 27 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Investigations Alanine aminotransferase increased	10.0% 27/271 • Number of events 43 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	4.5% 6/134 • Number of events 8 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Investigations Amylase increased	8.1% 22/271 • Number of events 44 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	3.0% 4/134 • Number of events 5 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Investigations Aspartate aminotransferase increased	9.2% 25/271 • Number of events 48 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	3.7% 5/134 • Number of events 6 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Metabolism and nutrition disorders Decreased appetite	5.9% 16/271 • Number of events 17 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	8.2% 11/134 • Number of events 15 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Metabolism and nutrition disorders Hyperglycaemia	5.2% 14/271 • Number of events 28 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	3.7% 5/134 • Number of events 7 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Metabolism and nutrition disorders Hyperuricaemia	5.9% 16/271 • Number of events 32 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	3.0% 4/134 • Number of events 12 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Metabolism and nutrition disorders Hypokalaemia	3.3% 9/271 • Number of events 9 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	7.5% 10/134 • Number of events 11 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Musculoskeletal and connective tissue disorders Arthralgia	8.5% 23/271 • Number of events 23 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	4.5% 6/134 • Number of events 6 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Musculoskeletal and connective tissue disorders Back pain	7.0% 19/271 • Number of events 20 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	4.5% 6/134 • Number of events 6 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Psychiatric disorders Insomnia	5.2% 14/271 • Number of events 15 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	3.7% 5/134 • Number of events 6 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Respiratory, thoracic and mediastinal disorders Cough	11.8% 32/271 • Number of events 37 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	11.2% 15/134 • Number of events 17 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.7% 10/271 • Number of events 10 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	5.2% 7/134 • Number of events 11 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Respiratory, thoracic and mediastinal disorders Pneumonitis	7.0% 19/271 • Number of events 20 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	4.5% 6/134 • Number of events 6 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Respiratory, thoracic and mediastinal disorders Productive cough	5.2% 14/271 • Number of events 16 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	5.2% 7/134 • Number of events 8 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Skin and subcutaneous tissue disorders Pruritus	6.3% 17/271 • Number of events 22 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	4.5% 6/134 • Number of events 6 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Endocrine disorders Hyperthyroidism	12.2% 33/271 • Number of events 41 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	6.0% 8/134 • Number of events 8 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Skin and subcutaneous tissue disorders Rash	7.7% 21/271 • Number of events 27 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	6.7% 9/134 • Number of events 11 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Endocrine disorders Hypothyroidism	18.8% 51/271 • Number of events 67 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	7.5% 10/134 • Number of events 13 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Gastrointestinal disorders Constipation	5.9% 16/271 • Number of events 17 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	7.5% 10/134 • Number of events 11 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.
Gastrointestinal disorders Diarrhoea	5.2% 14/271 • Number of events 16 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.	5.2% 7/134 • Number of events 10 • From time of signature of informed consent up to the DCO date 23-Jun-2024 (a maximum of approximately 2035 days) The Safety analysis set included all participants who received at least 1 dose of study treatment. All-cause mortality was determined for all randomized participants.