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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

Description

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to determine:

  • Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1
  • Overall survival (OS)

Core eligibility

Note: This is only a partial list of eligibility criteria.

Accepting patients who meet the following criteria:

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

Excluding patients who meet these criteria:

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

Accepting new patients

 

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