Trial Outcomes & Findings for Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION) (NCT NCT03775486)

Last Updated: 2026-02-10

Results Overview

Progression-free survival (PFS) based on investigator assessments according to Response Evaluation Criteria in Solid Tumours version 1.1. PFS is defined as time from date of randomization until the date of objective radiological disease progression using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

401 participants

Primary outcome timeframe

From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Results posted on

2026-02-10

Participant Flow

Initial therapy phase included participants who received durvalumab in combination with platinum based doublet chemotherapy.

Participant milestones

Participant milestones
Measure	Durvalumab/Olaparib Combination Therapy Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Initial Therapy Phase STARTED	0	401
Initial Therapy Phase COMPLETED	0	269
Initial Therapy Phase NOT COMPLETED	0	132
Maintenance Phase STARTED	134	135
Maintenance Phase Participants Who Received Durvalumab	134	134
Maintenance Phase Participants Who Received Olaparib/Placebo	128	128
Maintenance Phase Participants Who Terminated the Study	57	57
Maintenance Phase COMPLETED	77	78
Maintenance Phase NOT COMPLETED	57	57

Reasons for withdrawal

Reasons for withdrawal
Measure	Durvalumab/Olaparib Combination Therapy Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Initial Therapy Phase Other reason provided	0	15
Initial Therapy Phase Condition under investigation worsened	0	67
Initial Therapy Phase Protocol Violation	0	2
Initial Therapy Phase Adverse Event	0	34
Initial Therapy Phase Withdrawal by Subject	0	14
Maintenance Phase Withdrawal by Subject	13	12
Maintenance Phase Death	44	45

Baseline Characteristics

Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=135 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily	Total n=269 Participants Total of all reporting groups
Age, Continuous Mean age (years)	65.9 Years STANDARD_DEVIATION 9.59 • n=4 Participants	63.0 Years STANDARD_DEVIATION 9.50 • n=4 Participants	64.5 Years STANDARD_DEVIATION 9.64 • n=8 Participants
Age, Customized Less than 50 years	7 participants n=4 Participants	14 participants n=4 Participants	21 participants n=8 Participants
Age, Customized Equal to or greater than 50 years to less than 65 years	49 participants n=4 Participants	55 participants n=4 Participants	104 participants n=8 Participants
Age, Customized Equal to or greater than 65 years to less than 75 years	54 participants n=4 Participants	54 participants n=4 Participants	108 participants n=8 Participants
Age, Customized Equal to or greater than 75 years	24 participants n=4 Participants	12 participants n=4 Participants	36 participants n=8 Participants
Sex: Female, Male Female	36 Participants n=4 Participants	38 Participants n=4 Participants	74 Participants n=8 Participants
Sex: Female, Male Male	98 Participants n=4 Participants	97 Participants n=4 Participants	195 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=4 Participants	3 Participants n=4 Participants	5 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	132 Participants n=4 Participants	132 Participants n=4 Participants	264 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	37 Participants n=4 Participants	45 Participants n=4 Participants	82 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=4 Participants	1 Participants n=4 Participants	2 Participants n=8 Participants
Race (NIH/OMB) White	96 Participants n=4 Participants	89 Participants n=4 Participants	185 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=4 Participants	0 Participants n=4 Participants	0 Participants n=8 Participants
Smoking Status Current	35 Participants n=4 Participants	31 Participants n=4 Participants	66 Participants n=8 Participants
Smoking Status Former	74 Participants n=4 Participants	72 Participants n=4 Participants	146 Participants n=8 Participants
Smoking Status Never	25 Participants n=4 Participants	32 Participants n=4 Participants	57 Participants n=8 Participants
Histology Type Squamous Cell Carcinoma	58 participants n=4 Participants	59 participants n=4 Participants	117 participants n=8 Participants
Histology Type Nonsquamous Cell Carcinoma	76 participants n=4 Participants	76 participants n=4 Participants	152 participants n=8 Participants
World Health Organization/Eastern Cooperative Oncology Group Normal Activity	52 participants n=4 Participants	54 participants n=4 Participants	106 participants n=8 Participants
World Health Organization/Eastern Cooperative Oncology Group Restricted Activity	81 participants n=4 Participants	80 participants n=4 Participants	161 participants n=8 Participants
World Health Organization/Eastern Cooperative Oncology Group In Bed Less Than or Equal to 50 percent of the Time	1 participants n=4 Participants	1 participants n=4 Participants	2 participants n=8 Participants

PRIMARY outcome

Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Population: Full analysis set (maintenance phase)

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=135 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Progression-free Survival RECIST progression: Target Lesions	40 Participants	63 Participants
Progression-free Survival RECIST progression: Non Target Lesions	28 Participants	30 Participants
Progression-free Survival RECIST progression: New Lesions	44 Participants	39 Participants
Progression-free Survival Death in the absence of progression	8 Participants	9 Participants
Progression-free Survival Censored subjects: Censored RECIST progression	0 Participants	0 Participants
Progression-free Survival Censored subjects: Censored death	1 Participants	0 Participants
Progression-free Survival Censored subjects: Progression-free at time of analysis	44 Participants	34 Participants
Progression-free Survival Censored subjects: Progression-free prior to lost to follow-up	0 Participants	0 Participants
Progression-free Survival Censored subjects: Progression-free prior to withdrawal of consent	3 Participants	2 Participants
Progression-free Survival Censored subjects: Progression-free prior to discontinuation due to other reason	0 Participants	0 Participants
Progression-free Survival Censored subjects: No post-baseline evaluable tumor assessment	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From randomization until the date of death due to any cause, up to 18 months.

Population: Full analysis set (maintenance phase)

Overall survival (OS) across the maintenance phase. OS is defined as time from date of randomization until the date of death by any cause

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=135 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Overall Survival Censored participants (still in survival at follow up or terminated study prior to death)	90 Participants	90 Participants
Overall Survival Death	44 Participants	45 Participants

SECONDARY outcome

Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Population: Full analysis set for maintenance phase, participants with measurable disease at baseline

Objective response rate (ORR) defined as number of participants with complete response (CR) or partial response (PR) after randomization

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=129 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=131 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Objective Response Rate Response	22 Participants	18 Participants
Objective Response Rate No Response	107 Participants	113 Participants

SECONDARY outcome

Timeframe: From date of first documented response until objective radiological disease progression or death, up to 18 months.

Population: Participants with a response and with measurable disease at baseline from the full analysis set (maintenance phase)

Duration of response (DoR) defined as time from the date of first documented response following randomization until the first date of documented progression or death in the absence of disease progression. Percentage of participants remaining in response at 3, 6, 9 and 12 months estimated using the Kaplan-Meier method.

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=22 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=18 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Duration of Response Percentage of participants remaining in response at 3 months	90.5 percent	85.1 percent
Duration of Response Percentage of participants remaining in response at 6 months	79.1 percent	65.7 percent
Duration of Response Percentage of participants remaining in response at 9 months	69.2 percent	65.7 percent
Duration of Response Percentage of participants remaining in response at 12 months	69.2 percent	65.7 percent

SECONDARY outcome

Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Population: Full analysis set (maintenance phase); HRRm subgroup

Progression-free survival in homologous recombination repair related gene mutation (HRRm) population defined as time from date of randomization until the date of objective radiological disease progression in HRRm population using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1) or death (by any cause in the absence of progression).

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=5 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=9 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population RECIST progression: Target Lesions	1 Participants	5 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population RECIST progression: Non Target Lesions	2 Participants	2 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population RECIST progression: New Lesions	3 Participants	3 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Death in the absence of progression	0 Participants	0 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Censored subjects: Censored RECIST progression	0 Participants	0 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Censored subjects: Censored death	0 Participants	0 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Censored subjects: Progression-free at time of analysis	2 Participants	2 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Censored subjects: Progression-free prior to lost to follow-up	0 Participants	0 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Censored subjects: Progression-free prior to withdrawal of consent	0 Participants	0 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Censored subjects: Progression-free prior to discontinuation due to other reason	0 Participants	0 Participants
Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population Censored subjects: No post-baseline evaluable tumor assessment	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Assessed from start of initial therapy up to 2 years.

Population: Pharmacokinetic analysis set

Concentration (pharmacokinetics) of durvalumab

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Concentration of Durvalumab Cycle 14 (Maintenance Phase) Pre dose	276.612 μg/mL Geometric Coefficient of Variation 50.137	182.042 μg/mL Geometric Coefficient of Variation 39.341
Concentration of Durvalumab Cycle 17 (Maintenance Phase) Pre dose	264.096 μg/mL Geometric Coefficient of Variation 55.519	217.137 μg/mL Geometric Coefficient of Variation 92.229
Concentration of Durvalumab Cycle 20 (Maintenance Phase) Pre dose	528.046 μg/mL	112.276 μg/mL
Concentration of Durvalumab Month 03 (Maintenance Phase) Pre dose	12.289 μg/mL Geometric Coefficient of Variation 450.125	12.769 μg/mL Geometric Coefficient of Variation 225.898
Concentration of Durvalumab Cycle 11 (Maintenance Phase) Pre dose	210.794 μg/mL Geometric Coefficient of Variation 42.117	186.092 μg/mL Geometric Coefficient of Variation 39.823
Concentration of Durvalumab Cycle 01 Day 01 (Initial Therapy Phase) Post dose	417.152 μg/mL Geometric Coefficient of Variation 62.694	453.724 μg/mL Geometric Coefficient of Variation 43.258
Concentration of Durvalumab Cycle 02 Day 01 (Initial Therapy Phase) Pre dose	76.812 μg/mL Geometric Coefficient of Variation 84.586	76.959 μg/mL Geometric Coefficient of Variation 71.104
Concentration of Durvalumab Cycle 04 Day 01 (Initial Therapy Phase) Pre dose	155.461 μg/mL Geometric Coefficient of Variation 58.251	154.947 μg/mL Geometric Coefficient of Variation 50.102
Concentration of Durvalumab Cycle 01 (Maintenance Phase) Post dose	535.078 μg/mL Geometric Coefficient of Variation 40.119	524.306 μg/mL Geometric Coefficient of Variation 56.458
Concentration of Durvalumab Cycle 02 (Maintenance Phase) Pre dose	159.157 μg/mL Geometric Coefficient of Variation 53.813	160.315 μg/mL Geometric Coefficient of Variation 54.409
Concentration of Durvalumab Cycle 05 (Maintenance Phase) Pre dose	166.644 μg/mL Geometric Coefficient of Variation 54.948	147.848 μg/mL Geometric Coefficient of Variation 56.204
Concentration of Durvalumab Cycle 08 (Maintenance Phase) Pre dose	198.932 μg/mL Geometric Coefficient of Variation 47.024	154.057 μg/mL Geometric Coefficient of Variation 54.911

SECONDARY outcome

Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Population: Full analysis set (maintenance phase)

Disease-related symptoms assessed by change from baseline (for maintenance phase) in EORTC QLQ-LC13. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-LC13 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales in the EORTC QLQ-LC13. Higher scores on symptom scales represent greater symptom severity.

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=135 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Coughing	-2.14 change from baseline score Standard Error 1.980	-3.09 change from baseline score Standard Error 2.172
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Dyspnoea	-1.27 change from baseline score Standard Error 1.373	-0.76 change from baseline score Standard Error 1.500
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Pain in chest	1.31 change from baseline score Standard Error 1.410	3.57 change from baseline score Standard Error 1.575

SECONDARY outcome

Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Population: Full analysis set (maintenance phase)

Disease-related symptoms assessed by time to deterioration (for maintenance phase) in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13. Symptom deterioration is defined as an increase in the score from baseline of less than or equal to 10) that is confirmed at a subsequent assessment, or death (by any cause) in the absence of a clinically meaningful symptom deterioration. NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=135 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Dyspnoea	10.0 months Interval 5.6 to 12.2	9.7 months Interval 6.9 to 12.0
Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Coughing	11.7 months Interval 9.3 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	10.6 months Interval 7.7 to 12.6
Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Haemoptysis	15.0 months Interval 11.7 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	12.6 months Interval 10.9 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Pain In Chest	13.8 months Interval 10.8 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	11.5 months Interval 9.5 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Pain In Arm Or Shoulder	15.0 months Interval 10.2 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	9.7 months Interval 7.4 to 12.6
Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13 EORTC QLQ-LC13: Pain In Other Parts	10.3 months Interval 8.8 to 12.2	10.6 months Interval 8.6 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.

SECONDARY outcome

Timeframe: Includes all assessments occurring within the first 12 months of randomization or until disease progression, up to 18 months.

Population: Full analysis set (maintenance phase)

Disease-related symptoms and health-related quality of life (HRQoL) assessed by change from baseline (for maintenance phase) in EORTC QLQ-C30. Average adjusted mean over first 11 cycles is presented. The EORTC QLQ-C30 was scored according to the published scoring manual. An outcome variable consisting of a score from 0 to 100 was derived for each of the symptom scales, each of the function scales, and the global health status/QoL scale in the EORTC QLQ-C30. Higher scores on the global health status and function scales indicate better health status/function. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / quality of life (QoL) represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems.

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=135 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Fatigue	0.15 change from baseline score Standard Error 1.327	-1.49 change from baseline score Standard Error 1.456
Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Appetite loss	-0.13 change from baseline score Standard Error 1.613	-3.35 change from baseline score Standard Error 1.779

SECONDARY outcome

Timeframe: From randomization until date of first symptom deterioration that is confirmed, up to 18 months.

Population: Full analysis set (maintenance phase)

Disease-related symptoms and health-related quality of life (HRQoL) assessed by time to deterioration (for maintenance phase) in EORTC QLQ-C30. NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=135 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Dyspnoea	12.2 time to deterioration (months) Interval 10.0 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	11.0 time to deterioration (months) Interval 8.8 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Fatigue	8.8 time to deterioration (months) Interval 5.6 to 10.8	10 time to deterioration (months) Interval 8.0 to 12.6
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Nausea And Vomiting	12.2 time to deterioration (months) Interval 10.2 to 15.0	12.6 time to deterioration (months) Interval 9.7 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Pain	10.2 time to deterioration (months) Interval 7.4 to 12.2	9.7 time to deterioration (months) Interval 6.6 to 12.6
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Insomnia	13.8 time to deterioration (months) Interval 10.0 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	10.6 time to deterioration (months) Interval 8.6 to 12.6
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Appetite Loss	11.7 time to deterioration (months) Interval 10.1 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	11.5 time to deterioration (months) Interval 10.0 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Constipation	12.2 time to deterioration (months) Interval 10.0 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	12.0 time to deterioration (months) Interval 10.0 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 EORTC QLQ-C30: Diarrhoea	13.8 time to deterioration (months) Interval 10.2 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	11.5 time to deterioration (months) Interval 9.7 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 Physical Functioning	12.0 time to deterioration (months) Interval 9.3 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	12.0 time to deterioration (months) Interval 9.0 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 Role Functioning	10.0 time to deterioration (months) Interval 5.6 to 12.2	10.6 time to deterioration (months) Interval 8.8 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 Emotional Functioning	12.2 time to deterioration (months) Interval 9.3 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	11.0 time to deterioration (months) Interval 8.8 to 12.6
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 Cognitive Functioning	10.2 time to deterioration (months) Interval 6.9 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.	10.6 time to deterioration (months) Interval 8.6 to 12.6
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 Social Functioning	9.3 time to deterioration (months) Interval 7.4 to 12.2	10.0 time to deterioration (months) Interval 7.7 to NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.
Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30 Global Health Status/Quality of Life	10.2 time to deterioration (months) Interval 6.5 to 12.2	9.7 time to deterioration (months) Interval 7.4 to 12.0

SECONDARY outcome

Timeframe: Assessed from start of initial therapy up to 2 years.

Population: Anti-drug antibody (ADA) evaluable set

Presence of anti-drug antibodies (ADAs) for durvalumab, as assessed at 3, 6, 12, 16 and 20 weeks after start of treatment and every 12 weeks thereafter until 3 and 6 months after last dose of durvalumab

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=132 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=130 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Presence of Anti-drug Antibodies (ADAs) for Durvalumab ADA positive post-baseline and not detected at baseline (treatment-induced)	5 Participants	4 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab ADA not detected at post-baseline and positive at baseline	6 Participants	4 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab Treatment-boosted ADA	0 Participants	0 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab Persistent positive	0 Participants	3 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab Transient positive	5 Participants	2 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab Neutralizing anti-drug antibody positive at any visit	1 Participants	1 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab ADA prevalence (any ADA positive, baseline or post-baseline)	11 Participants	9 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab ADA incidence (treatment-induced or treatment-boosted)	5 Participants	4 Participants
Presence of Anti-drug Antibodies (ADAs) for Durvalumab ADA positive post-baseline and positive at baseline	0 Participants	1 Participants

SECONDARY outcome

Timeframe: From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Population: Safety analysis set. One participant randomized to the durvalumab/placebo group did not receive any durvalumab or placebo and was excluded from the safety analysis set.

Number of Participants with Treatment-Related Adverse Events as Assessed by Common Terminology Criteria for Adverse Events (CTCAE)

Outcome measures

Outcome measures
Measure	Durvalumab/Olaparib Combination Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/Olaparib 2 × 150-mg tablets for 300-mg dose twice daily	Durvalumab/Placebo Therapy n=134 Participants Initial Therapy Phase (up to 4 cycles): Durvalumab 50 mg/mL intravenous (IV) at a dose of 1500 mg every 3 weeks, and Standard of Care chemotherapy as follows: * Nab-paclitaxel: 100 mg/m2 IV on Days 1, 8, and 15 of each 3-week cycle * Carboplatin: Area under the concentration-time curve (AUC) 5 or 6 on Day 1 of each 3-week cycle * Cisplatin: 75 mg/m2 IV on Day 1 of each 3-week cycle * Gemcitabine: 1000 or 1250 mg/m2 IV on Days 1 and 8 of each 3-week cycle * Pemetrexed: 500 mg/m2 IV on Day 1 of each 3-week cycle Followed by Maintenance Phase: Durvalumab 50 mg/mL IV at a dose of 1500 mg every 4 weeks/matching placebo for oral tablet twice daily
Number of Participants With Treatment-Related Adverse Events	83 Participants	54 Participants

Adverse Events

Initial Therapy Phase

Serious events: 104 serious events

Other events: 368 other events

Deaths: 89 deaths

Durvalumab/Olaparib Combination Therapy

Serious events: 25 serious events

Other events: 116 other events

Deaths: 44 deaths

Durvalumab/Placebo Therapy

Serious events: 19 serious events

Other events: 104 other events

Deaths: 45 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 The Investigator shall be entitled to publish the results of, or make presentations related to, the Study, provided that any publications or presentations to be made within 2 years of completion of the Study shall require the Sponsor's prior written consent.
Publication restrictions are in place

Restriction type: OTHER