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Niraparib + Pembrolizumab for Lung Cancer (ZEAL-1L Trial)

Phase 3

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant must be >=18 years of age

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

ZEAL-1L Trial Summary

This trial is testing if adding niraparib to pembrolizumab maintenance therapy could improve progression-free survival and overall survival in participants with advanced or metastatic non-small cell lung cancer who have achieved stable disease, partial response, or complete response following completion of standard of care first-line platinum-based induction chemotherapy with pembrolizumab.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include fatigue, digestive issues like nausea and constipation from Niraparib; immune-related reactions such as skin rash or thyroid problems from Pembrolizumab; blood pressure changes; and potential bone marrow problems.

ZEAL-1L Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My lung cancer responded to initial chemotherapy and pembrolizumab treatment.

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I've completed 4-6 cycles of chemotherapy with pembrolizumab.

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My lung cancer diagnosis is confirmed and lacks specific genetic changes treatable with targeted therapy.

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I've completed 4-6 cycles of chemotherapy with pembrolizumab for my cancer.

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My lung cancer diagnosis is confirmed and lacks specific genetic changes treatable with targeted therapy.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My lung cancer responded to the initial chemotherapy and pembrolizumab treatment.

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My lung cancer is at an advanced stage and cannot be treated with standard therapy.

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I can swallow and keep down pills.

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My lung cancer is in an advanced stage or has spread to other parts.

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I am fully active or restricted in physically strenuous activity but can do light work.

ZEAL-1L Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS) in overall population

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

Secondary outcome measures

CNS PFS as assessed by BICR using RANO-BM

Change from Baseline in HRQoL and symptoms by EORTC QLQ-LC13 (Scores on a scale)

Change from Baseline in Health-related quality of life (HRQoL) and symptoms by EORTC QLQ-C30-item Core module (EORTC QLQ-C30) (Scores on a scale)

+11 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

ZEAL-1L Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Participants receiving niraparib plus pembrolizumabExperimental Treatment2 Interventions

Eligible participants will receive niraparib along with pembrolizumab.

Group II: Participants receiving placebo plus pembrolizumabPlacebo Group2 Interventions

Eligible participants will receive matching placebo along with pembrolizumab.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Niraparib

2018

Completed Phase 4

~1540

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,751 Previous Clinical Trials

8,066,806 Total Patients Enrolled

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,264 Total Patients Enrolled

Media Library

Pembrolizumab Clinical Trial Eligibility Overview. Trial Name: NCT04475939 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Participants receiving niraparib plus pembrolizumab, Participants receiving placebo plus pembrolizumab

Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT04475939 — Phase 3

Pembrolizumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT04475939 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been cleared by the FDA?

"Pembrolizumab has been studied in Phase 3 trials, so we have some data to support its efficacy. Furthermore, there is extensive safety data supporting the use of this medication."

Answered by AI

How many people can sign up for this clinical trial in total?

"The trial is currently ongoing, as indicated by the information available on clinicaltrials.gov. This specific study was first posted on October 26th 2020 and was last edited on August 26th 2022. In total, 650 patients are needed for the trial across 32 different enrolment sites."

Answered by AI

In how many places is this trial being conducted?

"There are a total of 32 enrolment sites for this trial, which are situated in Skokie, Chattanooga, Portland and other locations. If you decide to participate in this study, try to enroll at the location closest to you to reduce travel time commitments."

Answered by AI

Are new participants being accepted into this experiment right now?

"That is correct, the online information specifies that this trial is currently looking for participants. This particular study was first advertised on October 26th 2020 and was last updated on August 26th 2022. There are 650 slots open for patients across 32 different locations."

Answered by AI

What are the goals that researchers are hoping to achieve with this experiment?

"The primary objective of this study, as indicated by the sponsor GlaxoSmithKline, is to measure overall survival (OS) over a period of up to 3 years. In addition to the primary outcome, this study will also be measuring secondary outcomes including OS by PD-L1 status and PFS by investigator assessment. The change from baseline in health-related quality of life (HRQoL) and symptoms will also be measured using the EORTC 30-item Core module (EORTC QLQ-C30)."

Answered by AI

What other research has there been on Pembrolizumab?

"City of Hope first studied pembrolizumab in 2010 and, since then, 18545 clinical trials have completed. Presently, 1094 medical studies are actively recruiting with a high concentration in Skokie, Illinois."

Answered by AI

For what purpose is Pembrolizumab most commonly prescribed?

"Pembrolizumab is an immunotherapy medication that can be used to effectively treat patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

Recent research and studies

CancerJournal

JASPER: Phase 2 Trial of First‐line Niraparib Plus Pembrolizumab in Patients with Advanced Non–small Cell Lung Cancer

Ramalingam, Suresh S., Eddie Thara, Mark M. Awad, Afshin Dowlati, Basir Haque, Thomas E. Stinchcombe, Grace K. Dy, et al.. 2021. “JASPER: Phase 2 Trial of First‐line Niraparib Plus Pembrolizumab in Patients with Advanced Non–small Cell Lung Cancer”. Cancer. Wiley. doi:10.1002/cncr.33885.

clinicaltrials.govStudy

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

2020. "Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04475939.

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