Study of Durvalumab+Olaparib or Durvalumab After Treatmen... | NCT03775486

NCT03775486

ID	Type	Description	Link
2018-003460-30	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Durvalumab/Olaparib Combination Therapy	Experimental	Durvalumab/Olaparib Combination Therapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/Olaparib (maintenance phase)	Drug: Durvalumab Drug: Olaparib Drug: Nab-paclitaxel+carboplatin Drug: Gemcitabine+carboplatin Drug: Pemetrexed+carboplatin Drug: Gemcitabine+cisplatin Drug: Pemetrexed+cisplatin
Durvalumab Monotherapy	Experimental	Durvalumab Monotherapy: Durvalumab/SoC chemotherapy (initial therapy phase) followed by Durvalumab/placebo (maintenance phase)	Drug: Durvalumab Drug: Placebo for Olaparib Drug: Nab-paclitaxel+carboplatin Drug: Gemcitabine+carboplatin Drug: Pemetrexed+carboplatin Drug: Gemcitabine+cisplatin Drug: Pemetrexed+cisplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Durvalumab	Drug	Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.	Durvalumab Monotherapy Durvalumab/Olaparib Combination Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival	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).	From randomization until date of objective radiological disease progression or death, or last evaluable assessment in the absence of progression, up to 18 months

Secondary Outcomes

Measure	Description	Time Frame
Overall Survival	Overall survival (OS) across the maintenance phase. OS is defined as time from date of randomization until the date of death by any cause	From randomization until the date of death due to any cause, up to 18 months.
Objective Response Rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Histologically or cytologically documented Stage IV NSCLC not amenable to curative surgery or radiation.

Patients must have tumors that lack activating EGFR mutations and ALK fusions.

(WHO)/(ECOG) performance status of 0 or 1
No prior chemotherapy or any other systemic therapy for Stage IV NSCLC
Adequate organ and marrow function without blood transfusions in the past 28 days,
At least 1 tumor lesion, not previously irradiated, that can be accurately measured as per RECIST 1.1.

Key Inclusion criteria for randomization to maintenance treatment:

Documented radiographic evidence of CR, PR, or Stable Disease (SD) as per Investigator-assessed RECIST 1.1 following 4 cycles of platinum-based chemotherapy.
Creatinine Clearance (CrCl) ≥51 mL/min calculated by the investigator or designee using the Cockcroft-Gault equation or measured by 24-hour urine collection.
Ability to swallow whole oral medications.
All patients must provide a formalin-fixed, paraffin embedded tumor sample for tissue-based immunohistochemistry staining and DNA sequencing to determine PD-L1 expression, HRRm status, and other correlatives: either newly acquired or archival tumor samples (<3 years old) are acceptable. If available, a newly acquired tumor biopsy, collected as part of routine clinical practice, is preferred. If not available, an archival sample taken <3 years prior to screening is acceptable. If both an archival sample and a fresh tumor biopsy sample are available, both samples should be submitted for analysis and must be submitted as different samples using different accession numbers. Slides from different blocks cannot be mixed and submitted with the same kit.

Exclusion criteria

Mixed small-cell lung cancer and sarcomatoid variant NSCLC histology.
Prior exposure to any chemotherapy agents (except chemotherapy or chemoradiation for non-metastatic disease), polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerase (PARP) therapy, or immunomediated therapy
Active or prior documented autoimmune or inflammatory disorders.
Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.
Current or prior use of immunosuppressive medication within 14 days before the first dose of Investigational Product (IP)
untreated (CNS) metastases and/or carcinomatous meningitis
Active infection.

Exclusion criteria to be randomized to maintenance treatment:

• Inability to complete 4 cycles of platinum-based chemotherapy for any reason or discontinuation of Durvalumab during initial therapy.

Contacts/Locations Module

Name	Affiliation	Role
Myung-Ju Ahn, MD	Sungkyunkwan University School of Medicine, 135-710, Seoul, Korea	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Bonita Springs	Florida	34135	United States
Research Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37390980	Derived	Ahn MJ, Bondarenko I, Kalinka E, Cho BC, Sugawara S, Galffy G, Shim BY, Kislov N, Nagarkar R, Demedts I, Gans SJM, Mendoza Oliva D, Stewart R, Lai Z, Mann H, Shi X, Hussein M. Durvalumab in Combination With Olaparib Versus Durvalumab Alone as Maintenance Therapy in Metastatic NSCLC: The Phase 2 ORION Study. J Thorac Oncol. 2023 Nov;18(11):1594-1606. doi: 10.1016/j.jtho.2023.06.013. Epub 2023 Jun 29.

Label	URL
Related Info	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 14, 2020	Jul 4, 2022

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

FG0000 subjectsAll 401 participants received the same initial therapy prior to randomization. As such, the subjects listed under the placebo arm for this period are representative of all subjects in the initial therapy phase.

FG001401 subjectsAll 401 participants received the same initial therapy prior to randomization. As such, the subjects listed under the placebo arm for this period are representative of all subjects in the initial therapy phase.

The full analysis set for the maintenance phase is presented

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Age at screening

Mean

Standard Deviation

Years

Title

Denominators

Categories

Mean age (years)

Title	Measurements
	BG00065.9± 9.59 BG00163.0± 9.50 BG00264.5± 9.64

Age, Customized

Age at screening

Number

participants

Title

Denominators

Categories

Less than 50 years

Title	Measurements
	BG0007 BG00114 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00036 BG00138 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0013 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Smoking Status

Smoking status at screening

Count of Participants

Participants

Title

Denominators

Categories

Current

Title	Measurements
	BG00035 BG00131 BG002

Histology Type

Histology type at screening

Number

participants

Title

Denominators

Categories

Squamous Cell Carcinoma

Title	Measurements
	BG00058 BG00159 BG002

World Health Organization/Eastern Cooperative Oncology Group

World Health Organization/Eastern Cooperative Oncology Group measurements at baseline were collected prior to start of maintenance phase.

Number

participants

Title

Denominators

Categories

Normal Activity

Title	Measurements
	BG00052 BG00154

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Progression-free Survival

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).

Full analysis set (maintenance phase)

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Units	Counts
Participants	OG000134 OG001135

Title

Denominators

Categories

RECIST progression: Target Lesions

Title	Measurements
	OG00040 OG00163

RECIST progression: Non Target Lesions

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Log Rank		0.074		Hazard Ratio (HR)	0.76			2-Sided	95	0.57	1.02					Other
OG000	Median progression-free survival (months)

Secondary

Overall Survival

Overall survival (OS) across the maintenance phase.

OS is defined as time from date of randomization until the date of death by any cause

Full analysis set (maintenance phase)

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Objective Response Rate

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

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

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Duration of Response

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.

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

Posted

Number

percent

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Progression-free Survival in Homologous Recombination Repair Related Gene Mutation (HRRm) Population

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).

Full analysis set (maintenance phase); HRRm subgroup

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	Durvalumab/Placebo Therapy

Secondary

Concentration of Durvalumab

Concentration (pharmacokinetics) of durvalumab

Pharmacokinetic analysis set

Posted

Geometric Mean

Geometric Coefficient of Variation

μg/mL

Assessed from start of initial therapy up to 2 years.

ID	Title	Description
OG000	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
OG001	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

Secondary

Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

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.

Full analysis set (maintenance phase)

Posted

Mean

Standard Error

change from baseline score

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

ID	Title	Description
OG000	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
OG001

Secondary

Time to Deterioration in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Lung Cancer (LC)13

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.

Full analysis set (maintenance phase)

Posted

Median

95% Confidence Interval

months

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

ID	Title	Description
OG000	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

Secondary

Change From Baseline in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

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.

Full analysis set (maintenance phase)

Posted

Mean

Standard Error

change from baseline score

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

ID	Title	Description
OG000	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

Secondary

Time to Deterioration in EORTC Quality of Life Questionnaire (QLQ) QLQ-C30

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.

Full analysis set (maintenance phase)

Posted

Median

95% Confidence Interval

time to deterioration (months)

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

ID	Title	Description
OG000	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
OG001	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

Secondary

Presence of Anti-drug Antibodies (ADAs) for Durvalumab

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

Anti-drug antibody (ADA) evaluable set

Posted

Count of Participants

Participants

Assessed from start of initial therapy up to 2 years.

ID	Title	Description
OG000	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
OG001	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

Secondary

Number of Participants With Treatment-Related Adverse Events

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

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.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	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
OG001	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

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Initial Therapy Phase	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	89	401	104	401	368	401
EG001	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	44	134	25	134	116	134
EG002	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	45	135	19	134	104	134

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal abscess	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Endocarditis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Pneumonia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG00016 affected401 at risk EG0013 affected134 at risk EG0022 affected134 at risk
Respiratory tract infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Sepsis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Sialoadenitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Cancer pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Tumour pain	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG00013 affected401 at risk EG0015 affected134 at risk EG0020 affected134 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0006 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Hypothyroidism	Endocrine disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Secondary adrenocortical insufficiency	Endocrine disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Depression	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Mental status changes	Psychiatric disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Ataxia	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Depressed level of consciousness	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Epilepsy	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Seizure	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0012 affected134 at risk EG0020 affected134 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Superior vena cava syndrome	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0011 affected134 at risk EG0021 affected134 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0011 affected134 at risk EG0022 affected134 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0022 affected134 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Urinary retention	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Asthenia	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Chills	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Death	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Disease progression	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0022 affected134 at risk
Fatigue	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
General physical health deterioration	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Pain	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Pyrexia	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0011 affected134 at risk EG0021 affected134 at risk
Alanine aminotransferase increased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Creatinine renal clearance decreased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Influenza A virus test positive	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Influenza B virus test positive	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0011 affected134 at risk EG0020 affected134 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0000 affected401 at risk EG0010 affected134 at risk EG0021 affected134 at risk
Abscess oral	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Bronchitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Cellulitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Gastrointestinal bacterial infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Influenza	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Lung abscess	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Meningoencephalitis herpetic	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Pneumonia necrotising	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Septic shock	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Staphylococcal infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Urinary tract infection	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Viral diarrhoea	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0006 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Diplopia	Eye disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Cardiac failure	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Myocardial infarction	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Arteriosclerosis	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Hypertension	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Hypotension	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Jugular vein thrombosis	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Constipation	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Faecaloma	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0004 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Vomiting	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Renal failure	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Renal infarct	Renal and urinary disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Catheter site haematoma	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Malaise	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Non-cardiac chest pain	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0003 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Sudden death	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Neutrophil count decreased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Platelet count decreased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG0002 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG000188 affected401 at risk EG00135 affected134 at risk EG00211 affected134 at risk
Nausea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG000118 affected401 at risk EG00119 affected134 at risk EG00210 affected134 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (23.1)	Non-systematic Assessment	EG0001 affected401 at risk EG00116 affected134 at risk EG0029 affected134 at risk
Fatigue	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG00068 affected401 at risk EG00115 affected134 at risk EG0029 affected134 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG00019 affected401 at risk EG00113 affected134 at risk EG0028 affected134 at risk
Hypothyroidism	Endocrine disorders	MedDRA (23.1)	Non-systematic Assessment	EG00011 affected401 at risk EG0018 affected134 at risk EG00213 affected134 at risk
Asthenia	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG00035 affected401 at risk EG0018 affected134 at risk EG00210 affected134 at risk
Vomiting	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG00037 affected401 at risk EG00115 affected134 at risk EG0023 affected134 at risk
Weight decreased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG00033 affected401 at risk EG00112 affected134 at risk EG0026 affected134 at risk
Alanine aminotransferase increased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG00029 affected401 at risk EG0016 affected134 at risk EG00211 affected134 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG00053 affected401 at risk EG00111 affected134 at risk EG0026 affected134 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG00026 affected401 at risk EG00110 affected134 at risk EG0024 affected134 at risk
Pneumonia	Infections and infestations	MedDRA (23.1)	Non-systematic Assessment	EG00020 affected401 at risk EG0018 affected134 at risk EG0026 affected134 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG00049 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG00092 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (23.1)	Non-systematic Assessment	EG00060 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Constipation	Gastrointestinal disorders	MedDRA (23.1)	Non-systematic Assessment	EG00070 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG00042 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (23.1)	Non-systematic Assessment	EG00031 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Pyrexia	General disorders	MedDRA (23.1)	Non-systematic Assessment	EG00022 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG00023 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Neutrophil count decreased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG00046 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
Platelet count decreased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG00021 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk
White blood cell count decreased	Investigations	MedDRA (23.1)	Non-systematic Assessment	EG00025 affected401 at risk EG0010 affected134 at risk EG0020 affected134 at risk

First MCP Posted Date

ID	Term
C000613593	durvalumab
C531550	olaparib

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

NA is "not applicable". The upper confidence limit was not calculable because of an insufficient number of participants with events.