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| ID | Type | Description | Link |
|---|---|---|---|
| 3000-02-001 | Other Identifier | Tesaro |
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This is a multicenter, open-label, phase 2 study to evaluate the efficacy and safety of niraparib alone and in combination with PD-1 inhibitors in participants with locally advanced and metastatic non-small cell lung cancer (NSCLC). The study will consist of 2 stages. In stage 1, participants from Cohorts 1 and 2 will receive niraparib plus PD-1 inhibitor; pembrolizumab and participants from Cohort 3 will receive niraparib alone. In Stage 2, participants from Cohorts 1A and 2A will receive niraparib plus the PD-1 inhibitor, TSR-042 (Dostarlimab).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 1 (Cohort 1): Niraparib plus Pembrolizumab | Experimental | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors have high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) will receive combination of niraparib and a PD-1 inhibitor; pembrolizumab. |
|
| Stage 1 (Cohort 2): Niraparib plus Pembrolizumab | Experimental | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) will receive combination of niraparib and a PD-1 inhibitor; pembrolizumab. |
|
| Stage 1 (Cohort 3): Niraparib | Experimental | Participants with locally advanced and metastatic squamous NSCLC who have been previously treated with both platinum and either PD-1 or PD-L1 inhibitor will receive single agent niraparib. |
|
| Stage 2 (Cohort 1A): Niraparib plus TSR-042 (Dostarlimab) | Experimental | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) will receive combination of niraparib and a PD-1 inhibitor; TSR-042 (Dostarlimab). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib is an orally available, potent, highly selective poly adenosine diphosphate- ribose (poly ADP-ribose) polymerase-1 (PARP-1) and PARP-2 inhibitor. It will be available as 100 milligrams (mg) capsules and will be administered as 2 X 100 mg capsules (200 mg per day) orally once daily (QD). |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Cohort 1: Objective Response Rate (ORR) | ORR is the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Data has been presented for participants with NSCLC whose tumors have high PD-L1 expression (TPS>=50%). Confidence interval was calculated using binomial exact method. | Up to a maximum of 29 months |
| Stage 1: Cohort 2: Objective Response Rate | ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per RECIST v1.1. Data has been presented for participants with NSCLC having PD-L1 expression in tumors (TPS: 1 to 49%). Confidence interval was calculated using binomial exact method. | Up to a maximum of 17 months |
| Stage 1: Cohort 3: Objective Response Rate | ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per RECIST v1.1. Data is presented for participants with locally advanced and metastatic squamous NSCLC. Confidence interval was calculated using binomial exact method. | Up to a maximum of 6 months |
| Stage 2: Cohort 1A and Cohort 2A: Objective Response Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Cohort 1: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Stage 1: Cohort 1: Overall Survival (OS) | Overall survival was defined as the time from date of first dose to the date of death due to any cause. | Up to a maximum of 45 months |
| Stage 1: Cohort 2: Overall Survival |
General Inclusion Criteria:
Male or female participants at least 18 years of age.
Histological or cytological proven advanced (unresectable) or metastatic NSCLC as defined as stage IIIB (positive supraclavicular lymph nodes) not amenable to definitive chemoradiotherapy or stage IV NSCLC.
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate organ function, defined as:
Participant must have recovered to Grade 1 toxicity from prior cancer therapy (a participant with Grade 2 neuropathy or Grade 2 alopecia is an exception to this criterion and may qualify for this study).
Participant agrees to submit formalin fixed paraffin embedded (FFPE) tumor tissue specimen, which may have been collected at any time prior to screening. If no archival FFPE tumor tissue is available, participant agrees to undergo a tumor tissue biopsy before Cycle 1/Day 1. (For Cohort 3 only: if diagnosis was made by cytology and archival tissue is not available, participant will not need to provide tumor tissue).
Participants is able to take oral medications.
Female participant meets the following criteria:
a) Female participant (of childbearing potential) is not breastfeeding, has a negative serum pregnancy test within 72 hours prior to taking study drug, and agrees to abstain from activities that could result in pregnancy from enrollment through 180 days after the last dose of study treatment or is of nonchildbearing potential; or b) Female participant is of nonchildbearing potential, other than medical reasons, defined as follows: i) >=45 years of age and has not had menses for > 1 year. ii) Amenorrheic for < 2 years without a hysterectomy and oophorectomy and a follicle-stimulating hormone (FSH) value in the postmenopausal range upon screening evaluation.
iii) Post hysterectomy, bilateral oophorectomy, or tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the participant must be willing to use 2 highly effective contraception methods throughout the study, starting with the screening visit through 180 days after the last dose of study therapy.
Cohort Specific Inclusion Criteria:
Exclusion Criteria for Cohorts 1, 1A , 2 and 2A:
Exclusion criteria for Cohort 3:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Whittier | Alaska | 90603 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34478166 | Background | 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. |
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Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
A total of 69 participants were screened, of which 16 failed screening and 53 participants (41 in Stage 1 and 12 in Stage 2) were enrolled into the study. Data was not collected for Cohort 2A of Stage 2 as the Sponsor decided not to open this Cohort to enrollment.
This study consisted of two stages; Stage 1 (Cohorts 1, 2, 3) and Stage 2 (Cohorts 1A, 2A).
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 1 (Cohort 1): Niraparib + Pembrolizumab | Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Stage 1 (Up to a Maximum of 45 Months) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 12, 2021 | Aug 29, 2022 |
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Participants will receive niraparib either as monotherapy or in combination with pembrolizumab during Stage 1 of the study. Participants will receive niraparib in combination with TSR-042 (dostarlimab) during Stage 2 of the study.
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This will be an open-label study.
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|
| Stage 2 (Cohort 2A): Niraparib plus TSR-042 (Dostarlimab) | Experimental | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) will receive combination of niraparib and a PD-1 inhibitor; TSR-042 (Dostarlimab). |
|
|
| Pembrolizumab | Biological | Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G-4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands (PD-L1 and PD-L2). It will be available as 50 mg lyophilized powder single-use vials or 100 mg/4 milliliters (mL) (25 mg/mL) solution in a single-dose vial. It will be administered at a dose of 200 mg intravenous (IV) using a 30-minute IV infusion |
|
| TSR-042 (Dostarlimab) | Biological | TSR-042 (Dostarlimab) is a humanized mAb of the IgG4/kappa isotype that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2. It will be administered at a dose of 500 mg for every 3 weeks (Q3W) for first 4 cycles followed by 1000 mg for every 6 weeks (Q6W) for all subsequent cycles using a 30-minute IV infusion. TSR-042 (dostarlimab) will be supplied as a solution of 160 mg (20 mg/mL) or 500 mg (50 mg/mL) in a single-dose vial. |
|
ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per RECIST v1.1. Confidence interval was calculated using binomial exact method. |
| Up to a maximum of 17 months |
| Up to a maximum of 45 months |
| Stage 1: Cohort 2: Number of Participants With Non-SAEs and SAEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events | Up to a maximum of 17 months |
| Stage 1: Cohort 3: Number of Participants With Non-SAEs and SAEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events | Up to a maximum of 6 months |
| Stage 2: Cohorts 1A and 2A: Number of Participants With Non-SAEs and SAEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events. | Up to a maximum of 29 months |
| Stage 1: Cohort 1: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Up to a maximum of 45 months |
| Stage 1: Cohort 2: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Up to a maximum of 17 months |
| Stage 1: Cohort 3: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Up to a maximum of 6 months |
| Stage 2: Cohorts 1A and 2A: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Up to maximum 29 months |
| Stage 1: Cohort 1: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | Up to a maximum of 45 months |
| Stage 1: Cohort 2: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | Up to a maximum of 17 months |
| Stage 1 : Cohort 3: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | Up to a maximum of 6 months |
| Stage 2: Cohorts 1A and 2A: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | Up to a maximum of 29 months |
| Stage 1 : Cohort 1: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | Up to a maximum of 45 months |
| Stage 1 : Cohort 2: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | Up to a maximum of 17 months |
| Stage 1 : Cohort 3: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | Up to a maximum of 6 months |
| Stage 2: Cohorts 1A and 2A: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | Up to a maximum of 29 months |
| Stage 1 : Cohort 1: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | Up to a maximum of 45 months |
| Stage 1 : Cohort 2: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | Up to a maximum of 17 months |
| Stage 1 : Cohort 3: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | Up to a maximum of 6 months |
| Stage 2: Cohorts 1A and 2A: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | Up to a maximum of 29 months |
| Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab | Blood samples were collected at indicated time points. | Cycle 1 Day 1(Pre-dose and 30 Minutes, 1 Hour, 2 Hours, 4 Hours, 8 Hours, 96 Hours, 168 Hours Post-dose); Cycles 2, 4, 8 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days) |
| Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab | Blood samples were collected at indicated time points. | Cycle 1 Day 1 (Pre-dose and 30 Minutes, 1, 2, 4, 8, 24, 168, 336 Hours Post-dose), Cycles 2, 8 (Pre-dose and 4 Hours Post-dose), Cycle 4 (Pre-dose and 30 Minutes, 1, 2, 4, 8, 24, 96, 168, 336 Hours Post-dose) (each cycle of 21 days) |
| Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy | Blood samples were collected at indicated time points. | Cycle 1 Day 1 (Pre-dose and 4 Hours Post-dose), Cycles 2, 4 and 8 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days) |
| Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) | Blood samples were collected at indicated time points. | Cycle 1 Day 1 (Pre-dose and 4 Hours Post-dose), Cycles 2, 4 and 9 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days) |
Overall survival was defined as the time from date of first dose to the date of death due to any cause.
| Up to a maximum of 17 months |
| Stage 1: Cohort 3: Overall Survival | Overall survival was defined as the time from date of first dose to the date of death due to any cause. | Up to a maximum of 6 months |
| Stage 2: Cohorts 1A and 2A: Overall Survival | Overall survival was defined as the time from date of first dose to the date of death due to any cause. | Up to a maximum of 29 months |
| Port Saint Lucie |
| Florida |
| 34952 |
| United States |
| GSK Investigational Site | Atlanta | Georgia | 30322 | United States |
| GSK Investigational Site | Harvey | Illinois | 60426 | United States |
| GSK Investigational Site | Tinley Park | Illinois | 60487 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02215 | United States |
| GSK Investigational Site | Florham Park | New Jersey | 07932 | United States |
| GSK Investigational Site | Buffalo | New York | 14263 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Cleveland | Ohio | 44106 | United States |
| GSK Investigational Site | Columbus | Ohio | 31904 | United States |
| GSK Investigational Site | Toledo | Ohio | 43623 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Kennewick | Washington | 99336 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| FG001 | Stage 1 (Cohort 2): Niraparib + Pembrolizumab | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle. |
| FG002 | Stage 1 (Cohort 3): Niraparib | Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle. |
| FG003 | Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days). |
| FG004 | Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planned to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days). |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Stage 2 (Up to a Maximum of 29 Months) |
|
|
Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. Safety Population comprised of participants who received at least one dose of either study medications.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 1 (Cohort 1): Niraparib + Pembrolizumab | Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle. |
| BG001 | Stage 1 (Cohort 2): Niraparib + Pembrolizumab | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle. |
| BG002 | Stage 1 (Cohort 3): Niraparib | Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle. |
| BG003 | Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days). |
| BG004 | Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planned to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days). |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||
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| Primary | Stage 1: Cohort 1: Objective Response Rate (ORR) | ORR is the percentage of participants with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Data has been presented for participants with NSCLC whose tumors have high PD-L1 expression (TPS>=50%). Confidence interval was calculated using binomial exact method. | Modified intent-to-treat (mITT) Population comprised of all participants who received any study drug and did not withdraw consent prior to having at least one post-Baseline tumor assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 29 months |
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| Primary | Stage 1: Cohort 2: Objective Response Rate | ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per RECIST v1.1. Data has been presented for participants with NSCLC having PD-L1 expression in tumors (TPS: 1 to 49%). Confidence interval was calculated using binomial exact method. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 17 months |
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| Primary | Stage 1: Cohort 3: Objective Response Rate | ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per RECIST v1.1. Data is presented for participants with locally advanced and metastatic squamous NSCLC. Confidence interval was calculated using binomial exact method. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 6 months |
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| Primary | Stage 2: Cohort 1A and Cohort 2A: Objective Response Rate | ORR is the percentage of participants with a confirmed BOR of CR or PR in the analysis population where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Tumor assessment was done by the Investigator per RECIST v1.1. Confidence interval was calculated using binomial exact method. | mITT Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 17 months |
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| Secondary | Stage 1: Cohort 1: Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events | Safety Population comprised of participants who received at least one dose of either study medications. | Posted | Count of Participants | Participants | Up to a maximum of 45 months |
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| Secondary | Stage 1: Cohort 2: Number of Participants With Non-SAEs and SAEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events | Safety Population | Posted | Count of Participants | Participants | Up to a maximum of 17 months |
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| Secondary | Stage 1: Cohort 3: Number of Participants With Non-SAEs and SAEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events | Safety Population | Posted | Count of Participants | Participants | Up to a maximum of 6 months |
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| Secondary | Stage 2: Cohorts 1A and 2A: Number of Participants With Non-SAEs and SAEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. A SAE is defined as any untoward medical occurrence that, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an important medical event(s) as per medical and scientific judgment. Adverse events which were not Serious Adverse Events were considered as Non-Serious adverse events. | Safety Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. | Posted | Count of Participants | Participants | Up to a maximum of 29 months |
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| Secondary | Stage 1: Cohort 1: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Safety population | Posted | Count of Participants | Participants | Up to a maximum of 45 months |
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| Secondary | Stage 1: Cohort 2: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Safety population | Posted | Count of Participants | Participants | Up to a maximum of 17 months |
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| Secondary | Stage 1: Cohort 3: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Safety Population | Posted | Count of Participants | Participants | Up to a maximum of 6 months |
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| Secondary | Stage 2: Cohorts 1A and 2A: Number of Participants Discontinuing the Study Due to AEs | An AE is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. Number of participants discontinuing the study due to AEs have been summarized. | Safety Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. | Posted | Count of Participants | Participants | Up to maximum 29 months |
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| Secondary | Stage 1: Cohort 1: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 millimeter (mm) in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | mITT Population. Only those participants with confirmed response were analyzed. | Posted | Median | Inter-Quartile Range | Months | Up to a maximum of 45 months |
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| Secondary | Stage 1: Cohort 2: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | mITT Population. Only those participants with confirmed response were analyzed. | Posted | Median | Inter-Quartile Range | Months | Up to a maximum of 17 months |
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| Secondary | Stage 1 : Cohort 3: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | mITT Population. No participant had confirmed response. Hence, data for duration of response was not collected. | Posted | Up to a maximum of 6 months |
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| Secondary | Stage 2: Cohorts 1A and 2A: Duration of Response | Duration of Response was defined as the time from first documented CR or PR until the subsequently documented disease progression by RECIST v1.1 or death, whichever occurs earlier; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. | mITT Population. Only those participants with confirmed response were analyzed. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. | Posted | Median | Inter-Quartile Range | Months | Up to a maximum of 29 months |
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| Secondary | Stage 1 : Cohort 1: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 45 months |
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| Secondary | Stage 1 : Cohort 2: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 17 months |
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| Secondary | Stage 1 : Cohort 3: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 6 months |
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| Secondary | Stage 2: Cohorts 1A and 2A: Disease Control Rate | Disease Control Rate was defined as the percentage of participants with a best overall response of CR, PR or SD per RECIST v1.1; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be <10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. Confidence interval was calculated using binomial exact method. | mITT Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to a maximum of 29 months |
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| Secondary | Stage 1 : Cohort 1: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | mITT Population | Posted | Median | Inter-Quartile Range | Months | Up to a maximum of 45 months |
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| Secondary | Stage 1 : Cohort 2: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | mITT Population | Posted | Median | Inter-Quartile Range | Months | Up to a maximum of 17 months |
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| Secondary | Stage 1 : Cohort 3: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | mITT Population | Posted | Median | Inter-Quartile Range | Months | Up to a maximum of 6 months |
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| Secondary | Stage 2: Cohorts 1A and 2A: Progression-free Survival | Progression-free survival was defined as the time from the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progression was defined using RECIST v1.1 as a 20% increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions or the appearance of one or more new lesions. | mITT Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. | Posted | Median | Inter-Quartile Range | Months | Up to a maximum of 29 months |
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| Secondary | Stage 1: Cohort 1: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab | Blood samples were collected at indicated time points. | Pharmacokinetic Population comprised of participants who had at least one of measurable niraparib concentration. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Cycle 1 Day 1(Pre-dose and 30 Minutes, 1 Hour, 2 Hours, 4 Hours, 8 Hours, 96 Hours, 168 Hours Post-dose); Cycles 2, 4, 8 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days) |
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| Secondary | Stage 1: Cohort 2: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and Pembrolizumab | Blood samples were collected at indicated time points. | Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Cycle 1 Day 1 (Pre-dose and 30 Minutes, 1, 2, 4, 8, 24, 168, 336 Hours Post-dose), Cycles 2, 8 (Pre-dose and 4 Hours Post-dose), Cycle 4 (Pre-dose and 30 Minutes, 1, 2, 4, 8, 24, 96, 168, 336 Hours Post-dose) (each cycle of 21 days) |
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| Secondary | Stage 1: Cohort 3: Plasma Concentration of Niraparib Following Niraparib Monotherapy | Blood samples were collected at indicated time points. | Pharmacokinetic Population. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Cycle 1 Day 1 (Pre-dose and 4 Hours Post-dose), Cycles 2, 4 and 8 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days) |
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| Secondary | Stage 2: Cohorts 1A and 2A: Plasma Concentration of Niraparib Following Combination Therapy of Niraparib and TSR-042 (Dostarlimab) | Blood samples were collected at indicated time points. | Pharmacokinetic Population. Data was not collected for Cohort 2A of Stage 2 as no participant was enrolled into this Cohort of the study. Only those participants with data available at specified time points were analyzed. | Posted | Mean | Standard Deviation | Nanograms per milliliter | Cycle 1 Day 1 (Pre-dose and 4 Hours Post-dose), Cycles 2, 4 and 9 (Pre-dose and 4 Hours Post-dose) (each cycle of 21 days) |
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| Other Pre-specified | Stage 1: Cohort 1: Overall Survival (OS) | Overall survival was defined as the time from date of first dose to the date of death due to any cause. | mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study. | Posted | Up to a maximum of 45 months |
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| Other Pre-specified | Stage 1: Cohort 2: Overall Survival | Overall survival was defined as the time from date of first dose to the date of death due to any cause. | mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study. | Posted | Up to a maximum of 17 months |
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| Other Pre-specified | Stage 1: Cohort 3: Overall Survival | Overall survival was defined as the time from date of first dose to the date of death due to any cause. | mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study. | Posted | Up to a maximum of 6 months |
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| Other Pre-specified | Stage 2: Cohorts 1A and 2A: Overall Survival | Overall survival was defined as the time from date of first dose to the date of death due to any cause. | mITT Population. OS was removed as a secondary endpoint through a protocol amendment, following completion of the primary endpoint. OS will not be analyzed and reported for this study. | Posted | Up to a maximum of 29 months |
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All-cause mortality serious adverse events (SAE) and non-SAE were collected up to a maximum of 45 months in Cohort 1-Stage 1,up to a maximum of 17 months in Cohort 2-Stage 1,up to a maximum of 6 months in Cohort 3-Stage 1 and up to a maximum of 29 months in Cohort 1A-Stage 2.
Safety Population comprised of participants who received at least one dose of either study medication. Data was not collected for Cohort 2A-Stage 2 as no participant was enrolled in this Cohort.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stage 1 (Cohort 1): Niraparib + Pembrolizumab | Participants with locally advanced and metastatic non-small cell lung cancer (NSCLC) (all histologies) with no prior systemic chemotherapy or programmed cell death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitor treatment and whose tumors had high PD-L1 expression (tumor proportion score [TPS]: >= 50 percent [%]) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 milligrams (mg) orally once daily during each 21-day cycle. Pembrolizumab was administered as an intravenous (IV) infusion at a dose of 200 mg on Day 1 of each 21-day cycle. | 11 | 17 | 11 | 17 | 17 | 17 |
| EG001 | Stage 1 (Cohort 2): Niraparib + Pembrolizumab | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors had PD-L1 expression (TPS: 1% to 49%) received a combination of niraparib and pembrolizumab. Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. Pembrolizumab was administered as an IV infusion at a dose of 200 on Day 1 of each 21-day cycle. | 16 | 21 | 14 | 21 | 20 | 21 |
| EG002 | Stage 1 (Cohort 3): Niraparib | Participants with locally advanced and metastatic squamous NSCLC who were previously treated with both platinum and either PD-1 or PD-L1 inhibitor received single agent niraparib at a dose of 200 mg orally once daily during each 21-day cycle. | 1 | 3 | 1 | 3 | 3 | 3 |
| EG003 | Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab) | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have high PD-L1 expression (TPS: >= 50%) received a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was given at a dose of 200 mg orally once daily during each 21-day cycle. TSR-042 (Dostarlimab) was administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for subsequent cycles (each cycle of 21 days). | 6 | 12 | 7 | 12 | 12 | 12 |
| EG004 | Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) | Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days). | 0 | 0 | 0 | 0 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Pericardial effusion | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
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| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Facial paralysis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Mental status changes | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Psychotic disorder | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
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| Failure to thrive | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Lipase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pleural infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
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| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Candida infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site irritation | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Catheter site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Physical deconditioning | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hyperamylasaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Taste disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Levator syndrome | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Lip disorder | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachypnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Mucosal infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Blood magnesium decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Vitamin D decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Horner's syndrome | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Peroneal nerve palsy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Bladder spasm | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Hepatobiliary disease | Hepatobiliary disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Calculus prostatic | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Penile pain | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Prostatic pain | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Immobile | Social circumstances | MedDRA 23.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 27, 2019 | Aug 29, 2022 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C545685 | niraparib |
| C582435 | pembrolizumab |
| C000719628 | dostarlimab |
Not provided
Not provided
Not provided
| Death |
|
| Sponsor Decision |
|
| Male |
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| Asian |
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| Black or African American |
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| White |
|
| Unknown |
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| Participants |
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| OG001 |
| Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab) |
Participants with locally advanced and metastatic NSCLC (all histologies) with no prior systemic chemotherapy or PD-1/PD-L1 inhibitor treatment and whose tumors have PD-L1 expression (TPS: 1% to 49%) were planned to receive a combination of niraparib and TSR-042 (Dostarlimab). Niraparib was planned to be given at a dose of 200 mg orally once daily. TSR-042 (Dostarlimab) was planed to be administered as an IV infusion at a dose of 500 mg once every 3 weeks for first 4 cycles followed by 1000 mg dose once every 6 weeks for all subsequent cycles (each cycle of 21 days). |
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