Ended Therapeutic confirmatory (Phase III) Lung Cancer, Non-Small Cell

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants with Advanced/Metastatic Non-Small Cell Lung Cancer

EU CTIS ID: 2023-508443-40-00

What this study is testing

Dual Primary Objectives: To compare progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in the overall population To compare overall survival (OS) of niraparib plus pe mbrolizumab versus placebo plus pembrolizumab as maintenance therapy in the overall population

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

Participants must be ≥18 years of age. Note: Participants in Korea are eligible if they are ≥19 years of age at the time informed consent is obtained.
Participants with toxicity from standard of care (SoC) 1L induction therapy must have recovered to a level of organ and bone marrow function as defined by Inclusion Criterion #8 and there is no ongoing toxicity of CTCAE Grade >=3.
Participants must be able to swallow and retain orally administered study treatment.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP. OR • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in Appendix 3, during the intervention period and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. • A WOCBP must have a negative pregnancy test (either a highly sensitive urine or a serum pregnancy test as required by local regulations) within 72 hours before the first dose of study treatment. • If a highly sensitive urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study treatment are described in Section 6.6.2. • The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. See Appendix 3 for a list of acceptable birth control methods. Information must be captured appropriately within the site’s source documents.
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: • Refrain from donating sperm plus, either: • Be abstinent from sexual activity as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or • Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak; See Appendix 3)
Participants must be able to understand the study procedures and agree 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.

You likely can't join if

Participants have mixed small cell lung cancer or sarcomatoid variant NSCLC.
Participants have received prior systemic cytotoxic chemotherapy (IV or intraperitoneal), biological therapy (including checkpoint inhibitor), or hormonal therapy for cancer, or received thoracic radiation therapy of >30 Gy within 6 months of the first dose of the start of standard of care first-line induction therapy.
Participants have received live vaccine within 30 days of planned start of study randomization.
Participants have known hypersensitivity to the components of niraparib, placebo, or pembrolizumab or their formulation excipients.
Participants have undergone major surgery within 4 weeks of starting the first dose of study treatment or have not recovered from any effects of any major surgery.
Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.

See the full eligibility criteria

Who can join

Participants must be ≥18 years of age. Note: Participants in Korea are eligible if they are ≥19 years of age at the time informed consent is obtained.
Participants with toxicity from standard of care (SoC) 1L induction therapy must have recovered to a level of organ and bone marrow function as defined by Inclusion Criterion #8 and there is no ongoing toxicity of CTCAE Grade >=3.
Participants must be able to swallow and retain orally administered study treatment.
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: • Is not a WOCBP. OR • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in Appendix 3, during the intervention period and for at least 180 days after the last dose of study treatment and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study treatment. • A WOCBP must have a negative pregnancy test (either a highly sensitive urine or a serum pregnancy test as required by local regulations) within 72 hours before the first dose of study treatment. • If a highly sensitive urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study treatment are described in Section 6.6.2. • The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. See Appendix 3 for a list of acceptable birth control methods. Information must be captured appropriately within the site’s source documents.
Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study treatment: • Refrain from donating sperm plus, either: • Be abstinent from sexual activity as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent or • Must agree to use a male condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak; See Appendix 3)
Participants must be able to understand the study procedures and agree 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.
Participants must have 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.
Participants must have advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy [CRT]) or metastatic (Stage IV) NSCLC as defined by the AJCC 8th Edition Staging Manual.
Participants must have completed at least 4 but no more than 6 cycles of standard of care first line platinum-based induction chemotherapy with pembrolizumab (according to standard of care defined by NCCN and/or ESMO Clinical Practice Guidelines for NSCLC).
Participants must have SD, PR, or CR of their NSCLC per Investigator’s assessment after completion of 4 to 6 cycles of standard of care first-line platinum-based induction chemotherapy with pembrolizumab.
Participants must have an ECOG performance status of 0 or 1.
Participants must have a life expectancy of at least 12 weeks.
Participants must have adequate organ and bone marrow function defined as: Absolute neutrophil count: ≥1,500/μL Platelets: ≥100,000/μL Hemoglobin: ≥9 g/dL or 5.6 mmol/L CLCr: >30 mL/min as estimated by the Cockcroft Gault equation (Appendix 11) Total bilirubin: ≤1.5×ULN (except in participants with Gilbert’s syndrome. Participants with Gilbert’s syndrome: isolated bilirubin >1.5×ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%) AST and ALT: ≤2.5×ULN (unless liver metastases are present, in which case they must be ≤5×ULN) Note: CBC test should be obtained without transfusion or receipt of colony stimulating factors within 4 weeks prior to obtaining sample. Participants with current active liver or biliary disease are excluded (with the exception of Gilbert’s syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per Investigator assessment).
Participants must submit FFPE tumor specimens preferably collected after being diagnosed with metastatic disease and prior to initiating standard of care induction therapy (chemotherapy or radiation) (ie, collected at time of diagnosis of advanced [Stage IIIB/IIIC] or metastatic [Stage 4] NSCLC), from location(s) not irradiated prior to biopsy. If available, a FFPE tissue block should be provided; if not available, freshly cut, unstained slides (<30 days from the date of sectioning) are acceptable.

What rules you out

Participants have mixed small cell lung cancer or sarcomatoid variant NSCLC.
Participants have received prior systemic cytotoxic chemotherapy (IV or intraperitoneal), biological therapy (including checkpoint inhibitor), or hormonal therapy for cancer, or received thoracic radiation therapy of >30 Gy within 6 months of the first dose of the start of standard of care first-line induction therapy.
Participants have received live vaccine within 30 days of planned start of study randomization.
Participants have known hypersensitivity to the components of niraparib, placebo, or pembrolizumab or their formulation excipients.
Participants have undergone major surgery within 4 weeks of starting the first dose of study treatment or have not recovered from any effects of any major surgery.
Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
Participants have any clinically significant concomitant disease or condition (such as transfusion-dependent anemia or thrombocytopenia) that could interfere with, or for which the treatment might interfere with, the conduct of the study or that would, in the opinion of the Investigator, pose an unacceptable risk to the participants in this study.
Participants have any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study requirements and/or follow up procedures. Those conditions should be discussed with the participants before study entry.
Participants have high medical risk due to a serious, uncontrolled medical disorder; non malignant systemic disease; or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, active uncontrolled coagulopathy, bleeding disorder, or any psychiatric disorder that prohibits obtaining informed consent.
Participant 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.
Participants have presence of hepatitis B surface antigen or a positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, participants with presence of hepatitis B core antibody should also be excluded.
Participants have received prior PARP inhibitor(s) in prior lines of treatment.
Participants have a known history of MDS or AML
Participants have a known history of active tuberculosis [Lewinsohn, 2017].
Participants have 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.
Participants have systolic BP >140 mmHg or diastolic BP >90 mmHg
Participants have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
Participants have leptomeningeal disease, carcinomatous meningitis, symptomatic BM, or radiographic signs of CNS hemorrhage. Note: Participants with asymptomatic BM (ie, off corticosteroids and anticonvulsants for at least 7 days) are permitted.
Participants have received colony-stimulating factors (eg, granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment.
Participants have active or previously documented autoimmune or inflammatory disorder, including: a. Active infection b. Known diagnosis of immunodeficiency (including known history of human immunodeficiency, HIV, or infection) or is receiving chronic systemic steroid therapy (eg, >30 days) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment c. Active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. d. History of organ transplant
Participants are receiving chronic systemic steroids (prednisone >20 mg per day). Participants with asthma who require intermittent use of bronchodilators, inhaled steroids, or local steroid injections would not be excluded from the study.
Participants have previously or are currently participating in a treatment study of an investigational agent within 4 weeks of the first dose of standard of care first-line induction therapy preceding the study.

The study team makes the final eligibility decision.

Where it's taking place

Peru
Russian Federation
Australia
United States
Turkey
Argentina
Mexico
Colombia
Korea, Republic of
Switzerland
United Kingdom
Brazil

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Peru; Russian Federation; Australia; United States; Turkey; Argentina and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.