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Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants

Phase 2, Multi-Arm Study of Niraparib Administered Alone and in Combination With a PD-1 Inhibitor in Patients With Non-Small Cell Lung Cancer

NCT03308942•Tesaro, Inc.

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
•1. Absolute neutrophil count (ANC) \>= 1500 per microliter (/µL).
•2. Platelets \>= 100,000/µL.
•3. Hemoglobin \>= 9 grams per deciliter (g/dL) or \>= 5.6 millimoles per liter (mmol/L).
•4. Serum creatinine \<= 1.5 times upper limit of normal (ULN) or creatinine clearance \>= 50 milliliters per minute (mL/min) (as calculated using the Cockcroft Gault equation or measured using 24-hour urine creatinine clearance) for participants with creatinine levels \> 1.5 times institutional ULN.
•5. Total bilirubin \<= 1.5 times ULN except in participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll if direct bilirubin \<= 1.5 times ULN of the direct bilirubin.
+12 more criteria

Exclusion Criteria

•Participant has received systemic therapy for the treatment of advanced stage NSCLC. Completion of treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic disease.
•Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
•Known hypersensitivity to the components of niraparib, pembrolizumab, TSR-042 (Dostarlimab), or their excipients.
•Known EGFR (exon 19 and 21) mutations, ALK translocations, and/or ROS-1 translocations.
•Participant has a history or current condition (such as transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the participant's participation for the full duration of the study treatment.
•Known diagnosis of immunodeficiency or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
•Participant is immunocompromised, in the opinion of the Investigator.
•Current participation in a treatment study or past participation in a study of an investigational agent within 4 weeks before the first dose of study treatment.
•Symptomatic uncontrolled brain or leptomeningeal metastases. (To be considered "controlled," central nervous system \[CNS\] disease must have undergone treatment \[example, radiation or chemotherapy\] at least 1 month prior to study entry. The participant must not have any new or progressive signs or symptoms related to the CNS disease and must be taking \<= 10 mg of prednisone or equivalent per day or no steroids.) Participants who have untreated brain metastases and who are not symptomatic may enroll if the Investigator feels that treatment of these metastases is not indicated. A scan to confirm the absence of brain metastases is not required. Participants with spinal cord compression may be considered if they have received definitive treatment for this and evidence of clinically SD for 28 days.
•Active autoimmune disease that required systemic treatment in the past 2 years (with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (examples, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
+26 more criteria

Locations (16)

GSK Investigational Site

Whittier, Alaska, United States

GSK Investigational Site

Port Saint Lucie, Florida, United States

GSK Investigational Site

Atlanta, Georgia, United States

GSK Investigational Site

Harvey, Illinois, United States

GSK Investigational Site

Tinley Park, Illinois, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Florham Park, New Jersey, United States

GSK Investigational Site

Buffalo, New York, United States

GSK Investigational Site

Durham, North Carolina, United States

GSK Investigational Site

Canton, Ohio, United States

Key Dates

Start Date

September 29, 2017

Primary Completion Date

May 4, 2020

Completion Date

August 31, 2021

Last Updated

October 16, 2023

Enrollment

ACTUAL participants

Conditions

Neoplasms

Interventions

Niraparib

DRUG

Pembrolizumab

BIOLOGICAL

TSR-042 (Dostarlimab)

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effects of Single Agent Niraparib and Niraparib Plus Programmed Cell Death-1 (PD-1) Inhibitors in Non-Small Cell Lung Cancer Participants

Inclusion Criteria

Exclusion Criteria

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