Niraparib + Pembrolizumab for Lung Cancer

(ZEAL-1L Trial)

Recruiting at191 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Adults with advanced or metastatic non-small cell lung cancer (NSCLC) who've had some success with first-line platinum-based chemotherapy and pembrolizumab. They should be in stable condition, have good organ function, not be pregnant or breastfeeding, agree to use contraception, and have a life expectancy of at least 12 weeks.

Inclusion Criteria

I am 18 years old or older.

My lung cancer responded to initial chemotherapy and pembrolizumab treatment.

My organs and bone marrow are working well.

Exclusion Criteria

I haven't had severe lung inflammation or known lung disease needing steroids in the last 3 months.

I have not received any colony-stimulating factors in the last 4 weeks.

I have a history of MDS or AML.

Treatment Details

Interventions

• Niraparib (PARP Inhibitor)
• Pembrolizumab (PD-1 Inhibitor)
• Placebo (Other)

Trial Overview The trial is testing if adding Niraparib to Pembrolizumab maintenance therapy is better than using a placebo with Pembrolizumab after initial successful chemotherapy for NSCLC. The main goal is to see if this combination improves survival without the disease getting worse.

Participant Groups

Group I: Participants receiving niraparib plus pembrolizumab Experimental Treatment 2 Interventions

Eligible participants will receive niraparib along with pembrolizumab.

Group II: Participants receiving placebo plus pembrolizumab Placebo Group 2 Interventions

Eligible participants will receive matching placebo along with pembrolizumab.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School