Placebo-controlled Study Comparing Niraparib Plus Pembrol... | NCT04475939

NCT04475939

ID	Type	Description	Link
2023-508443-40	Registry Identifier	CTIS
2020-002202-20	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
Participants receiving niraparib plus pembrolizumab	Experimental	Eligible participants will receive niraparib along with pembrolizumab.	Drug: Niraparib Biological: Pembrolizumab
Participants receiving placebo plus pembrolizumab	Placebo Comparator	Eligible participants will receive matching placebo along with pembrolizumab.	Biological: Pembrolizumab Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Niraparib	Drug	Niraparib will be administered.	Participants receiving niraparib plus pembrolizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) - Complete and Partial Response (CR/PR) Population	PFS is defined as the time from the date of randomization to the date of first objectively documented disease progression (PD) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).	Up to 52 months

Secondary Outcomes

Measure	Description	Time Frame
Progression-free Survival (PFS) Assessed by BICR - Intent-to-Treat (ITT) Population	PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Participant must be >=18 years of age.
Has a histologically or cytologically confirmed diagnosis of NSCLC without known targetable driver alteration (either non-squamous or squamous histology; mixed histology is allowed for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting).
Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy) or metastatic (Stage IV) or metastatic (Stage IV) NSCLC.
Has completed at least 4 but no more than 6 cycles of SoC 1L platinum-based induction chemotherapy with pembrolizumab.
Has SD, PR, or CR of the NSCLC per Investigator's assessment after completion of 4 to 6 cycles of SoC 1L platinum-based induction chemotherapy with pembrolizumab.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Has a life expectancy of at least 12 weeks.
Has adequate organ and bone marrow function.
Must submit tumor specimens.
Must be able to swallow and retain orally administered study treatment.
A female is eligible to participate if she is not pregnant or breastfeeding and must follow contraceptive guidance during the treatment period and 180 days afterwards.
A male is eligible to participate if he agrees to contraceptive guidance and refrains from sperm donation during the intervention period and for at least 90 days after the last dose of study treatment.
Is able to understand the study procedures and agrees to participate in the study by providing written informed consent. Participants must be informed that their participation is voluntary. Participants will be required to sign a statement of informed consent to participate in the study.

Exclusion criteria:

Has mixed small cell lung cancer or sarcomatoid variant NSCLC.
Has received prior Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.
Has systolic blood pressure (BP) >140 millimeters of mercury (mmHg) or diastolic BP >90 mmHg.
Has any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage.
Has received colony-stimulating factors (granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment.
Has an active or previously documented autoimmune or inflammatory disorder.
Is receiving chronic systemic steroids (prednisone >20 mg per day) other than intermittent use of bronchodilators, inhaled steroids, or local steroid.
Has other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
Is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment.
Has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
Has a known history of active tuberculosis.
Has current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.

Contacts/Locations Module

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Fullerton	California	92835	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34478166	Derived	Ramalingam SS, Thara E, Awad MM, Dowlati A, Haque B, Stinchcombe TE, Dy GK, Spigel DR, Lu S, Iyer Singh N, Tang Y, Teslenko I, Iannotti N. JASPER: Phase 2 trial of first-line niraparib plus pembrolizumab in patients with advanced non-small cell lung cancer. Cancer. 2022 Jan 1;128(1):65-74. doi: 10.1002/cncr.33885. Epub 2021 Sep 3.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED	Intent-to-Treat (ITT) Population included all randomized participants whether or not randomized treatment was administered

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	Nov 6, 2024	Feb 25, 2026

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
BG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
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

Mean

Standard Deviation

YEARS

Title

Denominators

Categories

Title	Measurements
	BG00065.1± 8.75 BG00165.4± 9.08 BG00265.2± 8.91

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000106 BG001112 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

White

Title	Measurements
	BG000317 BG001322 BG002

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 (PFS) Assessed by Blinded Independent Central Review (BICR) - Complete and Partial Response (CR/PR) Population

PFS is defined as the time from the date of randomization to the date of first objectively documented disease progression (PD) as determined by blinded independent central review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Complete and Partial Response (CR/PR) Population included participants with best response to standard of care (SoC) induction chemotherapy with CR/PR in the intent-to-treat (ITT) Population (all randomized participants whether or not randomized treatment was administered).

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Units	Counts
Participants	OG000200 OG001201

Title

Denominators

Categories

Title	Measurements
	OG0005.55(4.14 to 8.28) OG0015.55(4.21 to 7.16)

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		Cox proportional hazard	Stratified log-rank with stratification factors: Histology (Squamous vs. Non-squamous) and PD-L1 status (TCs<1% / Not Evaluable versus>=1%) was used.	0.502		Hazard Ratio (HR)	1.00			2-Sided	95	0.79	1.27			Stratified Cox proportional hazards model with randomization stratification factors: Histology (Squamous versus Non-squamous) and PD-L1 status (TCs < 1% / Not Evaluable versus >= 1%) was used.		Superiority

Secondary

Progression-free Survival (PFS) Assessed by BICR - Intent-to-Treat (ITT) Population

PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

ITT Population included all randomized participants whether or not randomized treatment was administered.

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Overall Survival (OS) - CR/PR Population

OS is defined as the interval of time from the date of randomization to the date of death due to any cause.

Complete and partial response (CR/PR) Population

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Overall Survival (OS) - ITT Population

OS is defined as the interval of time from the date of randomization to the date of death due to any cause.

Intent-to-Treat Population

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Time to Progression (TTP) in the Central Nervous System (CNS) Assessed by BICR Using RANO-BM Criteria

TTP in the CNS is defined as the time from the date of randomization until the earliest date of documented PD in the CNS as assessed by BICR using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. This endpoint was analysed using a cumulative incidence competing-risk analysis, and the cumulative incidence rate was reported.

Intent-to-Treat Population

Posted

Number

95% Confidence Interval

Proportion of participants

At Month 6, 12, 18, 24, 30, 36, 42 and 48

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Progression-free Survival (PFS) as Assessed by the Investigator Using RECIST v1.1

PFS is defined as the time from the date of randomization to the date of first objectively documented PD as determined by investigators using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study).

Intent-to-Treat Population

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

CNS-PFS as Assessed by BICR Using RANO-BM Criteria

PFS is defined as the time from the date of randomization to the date of first radiographic progression in the CNS as determined by BICR using RANO-BM criteria or until death due to any cause (whichever occurs first). This endpoint was analysed using a cumulative incidence competing-risk analysis, and the cumulative incidence rate was reported.

Intent-to-Treat Population

Posted

Number

95% Confidence Interval

Proportion of participants

At Month 6, 12, 18, 24, 30, 36, 42 and 48

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Progression-free Survival (PFS) by Programmed Cell Death-ligand 1 (PD-L1) Status

Intent-to-Treat Population

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Overall Survival by Programmed Cell Death-ligand 1 (PD-L1) Status

OS is defined as the interval of time from the date of randomization to the date of death due to any cause. Participants were evaluated by PD-L1 status: Tumor Cells (TCs) ≥1% and TCs <1%/Not Evaluable.

Intent-to-Treat Population were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified category.

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Number of Participants With Minimally Clinically Important Difference (MCID) Status in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30)

The EORTC QLQ-C30 includes 30-items with single and multi-item scales. These included five functional scales (physical functioning [PF], role functioning [RF], cognitive functioning [CF], emotional functioning [EF] and social functioning [SF]), three symptom scales (fatigue, pain and nausea/vomiting [N/V]), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhoea, insomnia, dyspnoea, appetite loss [AL] and financial difficulties [FD]). Response options are 1 to 4. Scores were averaged and transformed to 0 to 100, a high score for functional scales/ GHS/QoL represent better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represent significant symptomatology. MCID status: Functional scales & GHS/QoL (Improved: ≥ +10; Stable: > -10 and < +10; Worsened: ≤ -10) and Symptom scales (Improved: ≤ -10; Stable: > -10 and < +10; Worsened: ≥ +10)

ITT Population included the Overall Number of Participants Analyzed. 'Number Analyzed' signifies participants evaluable for the specified time points. The "0 participants" analyzed represents that data was not collected at that particular time point for the respective Arms/Groups

Posted

Count of Participants

Participants

Baseline (Predose); Day (D) 1 of Cycle (C)2, C3, C4, C5-C67 (odd cycles only); End of Treatment (EoT, up to approx 49 months); Safety follow-up (SFU) 1 & 2 (up to approx 50 & 52 months)

ID	Title	Description
OG000	Niraparib + Pembrolizumab

Secondary

Changes From Baseline (CFB) in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 13-item Lung Cancer-specific Module (EORTC QLQ-LC13)

EORTC QLQ-LC13 is a 13-items questionnaire used in clinical research to assess health-related quality of life in lung cancer patients. The QLQ-LC13 includes questions assessing lung cancer-associated symptoms (Coughing, hemoptysis, dyspnea and site specific pain), treatment-related side effects (sore mouth, dysphagia, peripheral neuropathy and alopecia) and pain medication. Scores are calculated and transformed to range from 0 to 100. For the disease symptoms and side-effects of treatment scales a higher score represents a higher level of symptoms/problems and a negative change from baseline value indicates reduction (i.e. improvement) in symptoms.

Posted

Count of Participants

Participants

Baseline (Predose); Day (D) 1 of Cycle (C)2, C3, C4, C5-C67 (odd cycles only); EoT (up to approx 49 months); Safety follow-up (SFU) 1 & 2 (up to approx 50 & 52 months)

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Time to Deterioration (TTD) in EORTC Cancer Quality of Life Questionnaire LC13 (EORTC QLQ-LC13)

TTD in lung symptoms is defined as the time from randomization to first onset of ≥10 point increase from baseline with confirmation by a second adjacent ≥10 point increase in the same symptom domain for any of the three symptoms: dyspnea, chest pain, and cough, on the EORTC QLQ-LC13 were scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0-100. A lower score indicates a better outcome. A longer TTD indicates a better outcome.

Intent-to-Treat Population

Posted

Median

95% Confidence Interval

Months

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up
OG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Number of Participants With Treatment Emergent (TE) Adverse Events (AEs), Serious TEAEs and Adverse Events of Special Interest (AESIs)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose resulted in death, is life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, is a congenital anomaly/birth defect, other situations and is associated with liver injury or impaired liver function. SAEs are subsets of AEs. TEAE is an event that emerged during treatment having been absent pretreatment or worsened relative to the pretreatment state. AESI is any AE (serious or nonserious) that is of scientific and medical concern specific to niraparib for which ongoing monitoring and rapid communication by the Investigator to the Sponsor is warranted. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system.

Safety Population

Posted

Count of Participants

Participants

Up to 52 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Secondary

Plasma Concentrations of Niraparib

Blood samples were collected for plasma concentrations of niraparib.

Pharmacokinetics (PK) Population included all participants in the Safety Population from whom at least 1 PK sample was obtained and analyzed.

Posted

Mean

Standard Deviation

Nanogram/ millilitre (ng/mL)

Cycle 1 Day 1 (pre-dose, 3 h), Cycle 1 Day 15 (pre-dose, 3 h), Cycle 2 Day 1 (pre-dose, 3 h), Cycle 4 Day 1 (pre-dose), Cycle 7 Day 1 (pre-dose), and End of Treatment (pre-dose); up to approximately 49 months

ID	Title	Description
OG000	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up

Units	Counts
Participants	OG000

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	Niraparib + Pembrolizumab	Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up	196	329	97	329	293	329
EG001	Placebo + Pembrolizumab	Participants with NSCLC received Placebo tablet (two or three tablets) orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up	177	329	81	329	261	329

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00013 events13 affected329 at risk EG0018 events8 affected329 at risk
COVID-19	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0014 events4 affected329 at risk
Respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0004 events3 affected329 at risk EG0010 events0 affected329 at risk
Sepsis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0013 events3 affected329 at risk
Bronchitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Herpes zoster	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
Pneumonia aspiration	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
Urinary tract infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
Appendicitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Bacterial infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Bursitis infective	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Cellulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Diverticulitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Hepatitis B	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Pneumonia bacterial	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Prostate infection	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Pyelonephritis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Septic shock	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0005 events4 affected329 at risk EG0014 events4 affected329 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected329 at risk EG0013 events3 affected329 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0016 events5 affected329 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0013 events3 affected329 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0003 events1 affected329 at risk EG0014 events2 affected329 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0012 events2 affected329 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0013 events3 affected329 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Immune-mediated lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Epilepsy	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected329 at risk EG0011 events1 affected329 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Seizure	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
Syncope	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Brain oedema	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Cerebral infarction	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Dizziness	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Dysarthria	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Extrapyramidal disorder	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Myasthenia gravis	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Neuralgia	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Post herpetic neuralgia	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Vasogenic cerebral oedema	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG00013 events13 affected329 at risk EG0010 events0 affected329 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0005 events4 affected329 at risk EG0010 events0 affected329 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events1 affected329 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0004 events3 affected329 at risk EG0011 events1 affected329 at risk
Nausea	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected329 at risk EG0010 events0 affected329 at risk
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0004 events3 affected329 at risk EG0010 events0 affected329 at risk
Colitis	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Ileus	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Colonic fistula	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Constipation	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Duodenal obstruction	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected329 at risk EG0010 events0 affected329 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected329 at risk EG0010 events0 affected329 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events1 affected329 at risk
Myocardial infarction	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0012 events2 affected329 at risk
Arrhythmia	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Cardiac arrest	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Pericardial effusion	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Tachycardia	Cardiac disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Fatigue	General disorders	MedDRA v27.1	Systematic Assessment	EG0007 events5 affected329 at risk EG0010 events0 affected329 at risk
General physical health deterioration	General disorders	MedDRA v27.1	Systematic Assessment	EG0003 events3 affected329 at risk EG0012 events2 affected329 at risk
Pyrexia	General disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0012 events2 affected329 at risk
Sudden death	General disorders	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Chest pain	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Malaise	General disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Gastrointestinal procedural complication	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Injury	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0004 events4 affected329 at risk EG0010 events0 affected329 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events1 affected329 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0013 events3 affected329 at risk
Renal failure	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0006 events2 affected329 at risk EG0010 events0 affected329 at risk
Nephritis	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Blood creatinine increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0002 events1 affected329 at risk EG0011 events1 affected329 at risk
Platelet count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0002 events2 affected329 at risk EG0010 events0 affected329 at risk
Amylase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Weight decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0012 events2 affected329 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Feeding disorder	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Hepatitis	Hepatobiliary disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Immune-mediated hepatitis	Hepatobiliary disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Rash maculo-papular	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events2 affected329 at risk
Acute febrile neutrophilic dermatosis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Aortic aneurysm	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Hypertensive urgency	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Hypotension	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Hypophysitis	Endocrine disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0011 events1 affected329 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Adrenocortical insufficiency acute	Endocrine disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0012 events1 affected329 at risk
Uveitis	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Visual impairment	Eye disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk
Hypersensitivity	Immune system disorders	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v27.1	Systematic Assessment	EG0001 events1 affected329 at risk EG0010 events0 affected329 at risk
Disorientation	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG0000 events0 affected329 at risk EG0011 events1 affected329 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG000125 events87 affected329 at risk EG00157 events42 affected329 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00076 events45 affected329 at risk EG00179 events50 affected329 at risk
Constipation	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00059 events50 affected329 at risk EG00121 events18 affected329 at risk
Vomiting	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00044 events30 affected329 at risk EG00118 events16 affected329 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v27.1	Systematic Assessment	EG00023 events19 affected329 at risk EG0018 events8 affected329 at risk
Fatigue	General disorders	MedDRA v27.1	Systematic Assessment	EG00098 events57 affected329 at risk EG00181 events51 affected329 at risk
Asthenia	General disorders	MedDRA v27.1	Systematic Assessment	EG00070 events44 affected329 at risk EG00158 events40 affected329 at risk
Pyrexia	General disorders	MedDRA v27.1	Systematic Assessment	EG00031 events19 affected329 at risk EG00134 events27 affected329 at risk
Chest pain	General disorders	MedDRA v27.1	Systematic Assessment	EG00020 events17 affected329 at risk EG0018 events8 affected329 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG000256 events109 affected329 at risk EG00170 events46 affected329 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG000106 events55 affected329 at risk EG00120 events13 affected329 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA v27.1	Systematic Assessment	EG00040 events27 affected329 at risk EG00129 events14 affected329 at risk
Blood creatinine increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00071 events36 affected329 at risk EG00143 events30 affected329 at risk
Alanine aminotransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00039 events27 affected329 at risk EG00124 events17 affected329 at risk
Amylase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00044 events19 affected329 at risk EG00138 events23 affected329 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00040 events28 affected329 at risk EG00118 events12 affected329 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v27.1	Systematic Assessment	EG00049 events29 affected329 at risk EG00116 events10 affected329 at risk
Platelet count decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG00052 events25 affected329 at risk EG00111 events5 affected329 at risk
Weight decreased	Investigations	MedDRA v27.1	Systematic Assessment	EG00019 events18 affected329 at risk EG00114 events11 affected329 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00076 events51 affected329 at risk EG00165 events48 affected329 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v27.1	Systematic Assessment	EG00050 events44 affected329 at risk EG00146 events35 affected329 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG00051 events33 affected329 at risk EG00179 events46 affected329 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v27.1	Systematic Assessment	EG00052 events31 affected329 at risk EG00158 events38 affected329 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG00055 events45 affected329 at risk EG00162 events43 affected329 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v27.1	Systematic Assessment	EG00031 events24 affected329 at risk EG00131 events24 affected329 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG00064 events54 affected329 at risk EG00128 events26 affected329 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v27.1	Systematic Assessment	EG00032 events19 affected329 at risk EG00121 events11 affected329 at risk
COVID-19	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00045 events41 affected329 at risk EG00134 events32 affected329 at risk
Nasopharyngitis	Infections and infestations	MedDRA v27.1	Systematic Assessment	EG00028 events17 affected329 at risk EG00124 events20 affected329 at risk
Headache	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG00044 events32 affected329 at risk EG00124 events19 affected329 at risk
Dizziness	Nervous system disorders	MedDRA v27.1	Systematic Assessment	EG00025 events20 affected329 at risk EG00128 events21 affected329 at risk
Hypothyroidism	Endocrine disorders	MedDRA v27.1	Systematic Assessment	EG00019 events15 affected329 at risk EG00125 events23 affected329 at risk
Hyperthyroidism	Endocrine disorders	MedDRA v27.1	Systematic Assessment	EG0009 events9 affected329 at risk EG00122 events18 affected329 at risk
Hypertension	Vascular disorders	MedDRA v27.1	Systematic Assessment	EG00038 events33 affected329 at risk EG00125 events13 affected329 at risk
Insomnia	Psychiatric disorders	MedDRA v27.1	Systematic Assessment	EG00018 events17 affected329 at risk EG00111 events11 affected329 at risk

First MCP Posted Date

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
C545685	niraparib
C582435	pembrolizumab

Units	Counts
Participants	OG000200 OG001201

Units	Counts
Participants	OG000331 OG001335

Participants with Non-Small Cell Lung Cancer (NSCLC) received 200mg (two 100mg tablets) or 300 mg (three 100mg tablets) Niraparib tablet orally once daily from days 1 to 21, depending on their body weight and platelet count, in combination with 200 mg of Pembrolizumab as IV infusion on Day 1 of every 21-day cycle (Q3W). Treatment was continued for a maximum duration of up to 35 cycles, or until radiographic progressive disease (PD), unacceptable toxicity, death, withdrawal of consent, or becoming lost to follow-up