Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer
Summary
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 (SoC 1L) 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).
Timeline
- Start
- 2020-10-26
- Primary completion
- 2025-02-26
- Completion
- 2026-03-23
Outcome
Missed primary endpoint
registry analysis (superiority test); Niraparib + Pembrolizumab vs Placebo + Pembrolizumab; p = 0.502; Hazard Ratio (HR) 1.00 (95% CI 0.79 to 1.27); NCT04475939 ↗
paper The addition of niraparib to pembrolizumab for maintenance therapy in patients with advanced/metastatic NSCLC did not result in improved efficacy PMID 42431263 ↗
Publications
- Ramalingam SS, Velcheti V, Altan M, de Castro G Jr, Thomas M, Sanborn RE, Mazieres J, Schuler M, Isaksson J, Schenker M, Poddubskaya E, Kim YJ, Parakh S, Liu W, Neibauer MW, Aghera V, Chiu G, Peters S. Phase 3 Study of Niraparib-Plus-Pembrolizumab as Maintenance Therapy for Advanced/Metastatic Non-Small Cell Lung Cancer (ZEAL-1L). J Thorac Oncol. 2026 Jul 10:104087. doi: 10.1016/j.jtho.2026.104087. Online ahead of print.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Niraparib | Small molecule | 300 mg | Oral |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |