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Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (ZEAL-1L)

Primary Purpose

Lung Cancer, Non-Small Cell

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Niraparib

Pembrolizumab

Placebo

About this trial

This is an interventional treatment trial for Lung Cancer, Non-Small Cell focused on measuring Niraparib, Pembrolizumab, Maintenance therapy, Chemotherapy, Platinum-based

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion 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.

Exclusion 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Participants receiving niraparib plus pembrolizumab

Participants receiving placebo plus pembrolizumab

Arm Description

Eligible participants will receive niraparib along with pembrolizumab.

Eligible participants will receive matching placebo along with pembrolizumab.

Outcomes

Primary Outcome Measures

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

PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR or death from any cause in the absence of progression, whichever occurs first.

Overall survival (OS) in overall population

OS is defined as the time from randomization to the date of death due to any cause.

Secondary Outcome Measures

PFS assessed by BICR using RECIST v 1.1 in non-squamous histology (NSQ) population

PFS assessed by BICR using RECIST v 1.1 in complete and partial response (CR/PR) population

OS in NSQ population

OS is defined as the time from randomization to the date of death due to any cause.

OS in CR/PR population

OS is defined as the time from randomization to the date of death due to any cause

Time to progression (TTP)

TTP in the Central nervous system (CNS) is defined as the time from the date of randomization until the earliest date of documented PD in the CNS, based on BICR assessment using response assessment in neuro-oncology brain metastases (RANO-BM) criteria.

PFS by investigator assessment using RECIST v1.1

PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by the Investigator using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first.

CNS PFS as assessed by BICR using RANO-BM

PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR using RANO-BM criteria.

PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status

PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR using RECIST v1.1 or death from any cause in the absence of progression, whichever occurs first. PFS will be assessed by PD-L1 status (PD-L1 tumor cells [TCs] less than [<]1% and not evaluable (NE) versus more than or equal to [>=]1%).

OS by PD-L1 status

OS is defined as the time from randomization to the date of death due to any cause. OS will be assessed by PD-L1 status (PD-L1-TCs <1% and NE versus >=1%).

Time to Deterioration (TTD) in Lung Symptoms

TTD is defined as the time from randomization to meaningful deterioration as measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 13-item lung cancer-specific module (EORTC QLQ-LC13) questionnaire.

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)

EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.

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

The EORTC QLQ-LC13 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer participants.

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

AEs, SAEs and AESIs will be collected.

Plasma concentrations of niraparib

Blood samples will be collected to assess the plasma concentrations of niraparib.

Full Information

NCT ID

NCT04475939

First Posted

July 14, 2020

Last Updated

March 8, 2023

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT04475939

Brief Title

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

Acronym

ZEAL-1L

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 26, 2020 (Actual)

Primary Completion Date

December 20, 2024 (Anticipated)

Study Completion Date

February 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer, Non-Small Cell

Keywords

Niraparib, Pembrolizumab, Maintenance therapy, Chemotherapy, Platinum-based

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Multicenter, randomized, double-blind, placebo-controlled study.

Masking

ParticipantCare ProviderInvestigator

Masking Description

The participant, Investigator, study staff, and the Sponsor study team will be blinded.

Allocation

Randomized

Enrollment

666 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants receiving niraparib plus pembrolizumab

Arm Type

Experimental

Arm Description

Eligible participants will receive niraparib along with pembrolizumab.

Arm Title

Participants receiving placebo plus pembrolizumab

Arm Type

Placebo Comparator

Arm Description

Eligible participants will receive matching placebo along with pembrolizumab.

Intervention Type

Drug

Intervention Name(s)

Niraparib

Intervention Description

Niraparib will be administered

Intervention Type

Drug

Intervention Name(s)

Pembrolizumab

Intervention Description

Pembrolizumab will be administered

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Matching placebo will be administered

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Up to approximately 3 years

Title

Overall survival (OS) in overall population

Description

OS is defined as the time from randomization to the date of death due to any cause.

Time Frame

Up to approximately 5 years

Secondary Outcome Measure Information:

Title

PFS assessed by BICR using RECIST v 1.1 in non-squamous histology (NSQ) population

Description

Time Frame

Up to approximately 3 years

Title

PFS assessed by BICR using RECIST v 1.1 in complete and partial response (CR/PR) population

Description

Time Frame

Up to approximately 3 years

Title

OS in NSQ population

Description

OS is defined as the time from randomization to the date of death due to any cause.

Time Frame

Up to approximately 5 years

Title

OS in CR/PR population

Description

OS is defined as the time from randomization to the date of death due to any cause

Time Frame

Up to approximately 5 years

Title

Time to progression (TTP)

Description

Time Frame

Up to approximately 3 years

Title

PFS by investigator assessment using RECIST v1.1

Description

Time Frame

Up to approximately 3 years

Title

CNS PFS as assessed by BICR using RANO-BM

Description

PFS is defined as the time from the date of randomization to the date of first radiographic progression as determined by BICR using RANO-BM criteria.

Time Frame

Up to approximately 3 years

Title

PFS as assessed by BICR using RECIST v1.1 by programmed cell death-ligand 1 (PD-L1) status

Description

Time Frame

Up to approximately 3 years

Title

OS by PD-L1 status

Description

OS is defined as the time from randomization to the date of death due to any cause. OS will be assessed by PD-L1 status (PD-L1-TCs <1% and NE versus >=1%).

Time Frame

Up to approximately 5 years

Title

Time to Deterioration (TTD) in Lung Symptoms

Description

Time Frame

Up to approximately 3 years

Title

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)

Description

EORTC QLQ-C30 is a validated questionnaire to assess overall health-related quality of life in participants with cancer.

Time Frame

Baseline, Day 1 in Cycles 1, 2, 3, 4, 5 (Each cycle is of 21 Days); thereafter every 2 cycles until 90 days after last treatment dose (up to approximately 3 years)

Title

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

Description

The EORTC QLQ-LC13 is a clinically valid and useful tool for assessing disease- and treatment-specific symptoms in lung cancer participants.

Time Frame

Baseline, Day 1 in Cycles 1, 2, 3, 4, 5 (Each cycle is of 21 Days); thereafter every 2 cycles until 90 days after last treatment dose (up to approximately 3 years)

Title

Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse events of special interest (AESIs)

Description

AEs, SAEs and AESIs will be collected.

Time Frame

Up to approximately 3 years

Title

Plasma concentrations of niraparib

Description

Blood samples will be collected to assess the plasma concentrations of niraparib.

Time Frame

Up to approximately 3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion 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 for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting). Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy) or metastatic (Stage IV) 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 90 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. Exclusion 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

GSK Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

GSK Investigational Site

City

Sacramento

State/Province

California

ZIP/Postal Code

95816

Country

United States

Facility Name

GSK Investigational Site

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

GSK Investigational Site

City

Lone Tree

State/Province

Colorado

ZIP/Postal Code

80128

Country

United States

Facility Name

GSK Investigational Site

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

GSK Investigational Site

City

Fleming Island

State/Province

Florida

ZIP/Postal Code

32003

Country

United States

Facility Name

GSK Investigational Site

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

GSK Investigational Site

City

Newnan

State/Province

Georgia

ZIP/Postal Code

30265

Country

United States

Facility Name

GSK Investigational Site

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

GSK Investigational Site

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

GSK Investigational Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01655

Country

United States

Facility Name

GSK Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

GSK Investigational Site

City

Morristown

State/Province

New Jersey

ZIP/Postal Code

07962

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016-4744

Country

United States

Facility Name

GSK Investigational Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

GSK Investigational Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97401

Country

United States

Facility Name

GSK Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15212

Country

United States

Facility Name

GSK Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

GSK Investigational Site

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75246

Country

United States

Facility Name

GSK Investigational Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

GSK Investigational Site

City

Plano

State/Province

Texas

ZIP/Postal Code

75075-7787

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78217

Country

United States

Facility Name

GSK Investigational Site

City

Sherman

State/Province

Texas

ZIP/Postal Code

75090

Country

United States

Facility Name

GSK Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

GSK Investigational Site

City

Waco

State/Province

Texas

ZIP/Postal Code

76712

Country

United States

Facility Name

GSK Investigational Site

City

Fairfax

State/Province

Virginia

ZIP/Postal Code

22030

Country

United States

Facility Name

GSK Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1012AAR

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1125ABD

Country

Argentina

Facility Name

GSK Investigational Site

City

Florida

State/Province

Buenos Aires

ZIP/Postal Code

1602

Country

Argentina

Facility Name

GSK Investigational Site

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Facility Name

GSK Investigational Site

City

Cipoletti

State/Province

Río Negro

ZIP/Postal Code

R8324CVE

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000DSV

Country

Argentina

Facility Name

GSK Investigational Site

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

S2000KZE

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autonoma de Buenos Aires

ZIP/Postal Code

C1426AGE

Country

Argentina

Facility Name

GSK Investigational Site

City

Ciudad Autónoma de Buenos Aires

ZIP/Postal Code

C1426ABP

Country

Argentina

Facility Name

GSK Investigational Site

City

Cordoba

ZIP/Postal Code

X5004FHP

Country

Argentina

Facility Name

GSK Investigational Site

City

Mar del Plata

ZIP/Postal Code

B7600FYK

Country

Argentina

Facility Name

GSK Investigational Site

City

Blacktown

State/Province

New South Wales

ZIP/Postal Code

2148

Country

Australia

Facility Name

GSK Investigational Site

City

Hobart

State/Province

Tasmania

ZIP/Postal Code

7000

Country

Australia

Facility Name

GSK Investigational Site

City

Ballarat

State/Province

Victoria

ZIP/Postal Code

3350

Country

Australia

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

GSK Investigational Site

City

Brussels

ZIP/Postal Code

1200

Country

Belgium

Facility Name

GSK Investigational Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

GSK Investigational Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

GSK Investigational Site

City

Roeselaere

ZIP/Postal Code

8800

Country

Belgium

Facility Name

GSK Investigational Site

City

Salvador

State/Province

Bahía

ZIP/Postal Code

41252-190

Country

Brazil

Facility Name

GSK Investigational Site

City

Cachoeiro Do Itapemirim

State/Province

Espírito Santo

ZIP/Postal Code

29308-014

Country

Brazil

Facility Name

GSK Investigational Site

City

Belo Horizonte

State/Province

Minas Gerais

ZIP/Postal Code

30110-022

Country

Brazil

Facility Name

GSK Investigational Site

City

Uberlândia

State/Province

Minas Gerais

ZIP/Postal Code

38408-150

Country

Brazil

Facility Name

GSK Investigational Site

City

Curitiba

State/Province

Paraná

ZIP/Postal Code

80040-170

Country

Brazil

Facility Name

GSK Investigational Site

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90610-000

Country

Brazil

Facility Name

GSK Investigational Site

City

Rio de Janeiro

ZIP/Postal Code

22250-905

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

01308-901

Country

Brazil

Facility Name

GSK Investigational Site

City

São Paulo

ZIP/Postal Code

01509-010

Country

Brazil

Facility Name

GSK Investigational Site

City

Panagyurishte

ZIP/Postal Code

4500

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Ruse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Sofia

ZIP/Postal Code

1632

Country

Bulgaria

Facility Name

GSK Investigational Site

City

Temuco

State/Province

Región De La Araucania

ZIP/Postal Code

5360000

Country

Chile

Facility Name

GSK Investigational Site

City

Providencia

State/Province

Región Metro De Santiago

ZIP/Postal Code

7500653

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

7500921

Country

Chile

Facility Name

GSK Investigational Site

City

Bogota

ZIP/Postal Code

5600520

Country

Colombia

Facility Name

GSK Investigational Site

City

Monteria

ZIP/Postal Code

230018

Country

Colombia

Facility Name

GSK Investigational Site

City

Brest cedex

ZIP/Postal Code

29609

Country

France

Facility Name

GSK Investigational Site

City

Créteil cedex

ZIP/Postal Code

94010

Country

France

Facility Name

GSK Investigational Site

City

Grenoble cedex 9

ZIP/Postal Code

38043

Country

France

Facility Name

GSK Investigational Site

City

Lille cedex

ZIP/Postal Code

59037

Country

France

Facility Name

GSK Investigational Site

City

Nantes cedex 1

ZIP/Postal Code

44093

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

GSK Investigational Site

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

GSK Investigational Site

City

Rennes Cedex 9

ZIP/Postal Code

35033

Country

France

Facility Name

GSK Investigational Site

City

Strasbourg

ZIP/Postal Code

67200

Country

France

Facility Name

GSK Investigational Site

City

Toulon cedex

ZIP/Postal Code

83056

Country

France

Facility Name

GSK Investigational Site

City

Toulouse cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

GSK Investigational Site

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69126

Country

Germany

Facility Name

GSK Investigational Site

City

Stuttgart

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

70376

Country

Germany

Facility Name

GSK Investigational Site

City

Gauting

State/Province

Bayern

ZIP/Postal Code

82131

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

80336

Country

Germany

Facility Name

GSK Investigational Site

City

Muenchen

State/Province

Bayern

ZIP/Postal Code

81925

Country

Germany

Facility Name

GSK Investigational Site

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60488

Country

Germany

Facility Name

GSK Investigational Site

City

Hannover

State/Province

Niedersachsen

ZIP/Postal Code

30459

Country

Germany

Facility Name

GSK Investigational Site

City

Bonn

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

53113

Country

Germany

Facility Name

GSK Investigational Site

City

Essen

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

45147

Country

Germany

Facility Name

GSK Investigational Site

City

Hemer

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

58675

Country

Germany

Facility Name

GSK Investigational Site

City

Velbert

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

42551

Country

Germany

Facility Name

GSK Investigational Site

City

Halle

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06120

Country

Germany

Facility Name

GSK Investigational Site

City

Grosshansdorf

State/Province

Schleswig-Holstein

ZIP/Postal Code

22927

Country

Germany

Facility Name

GSK Investigational Site

City

Jena

State/Province

Thueringen

ZIP/Postal Code

07747

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20251

Country

Germany

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

115 27

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11526

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

11528

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

15562

Country

Greece

Facility Name

GSK Investigational Site

City

Athens

ZIP/Postal Code

185 37

Country

Greece

Facility Name

GSK Investigational Site

City

Heraklion,Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

GSK Investigational Site

City

Larisa

ZIP/Postal Code

41110

Country

Greece

Facility Name

GSK Investigational Site

City

Maroussi

ZIP/Postal Code

15123

Country

Greece

Facility Name

GSK Investigational Site

City

Maroussi

ZIP/Postal Code

15125

Country

Greece

Facility Name

GSK Investigational Site

City

N. Faliro

ZIP/Postal Code

185 47

Country

Greece

Facility Name

GSK Investigational Site

City

Patra

ZIP/Postal Code

26500

Country

Greece

Facility Name

GSK Investigational Site

City

Rio/Patras

ZIP/Postal Code

26500

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

54007

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

54622

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

54645

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

57001

Country

Greece

Facility Name

GSK Investigational Site

City

Thessaloniki

ZIP/Postal Code

57010

Country

Greece

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

GSK Investigational Site

City

Budapest

ZIP/Postal Code

H-1122

Country

Hungary

Facility Name

GSK Investigational Site

City

Gyöngyös

ZIP/Postal Code

3200

Country

Hungary

Facility Name

GSK Investigational Site

City

Tatabánya

ZIP/Postal Code

2800

Country

Hungary

Facility Name

GSK Investigational Site

City

Törökbálint

ZIP/Postal Code

2045

Country

Hungary

Facility Name

GSK Investigational Site

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

GSK Investigational Site

City

Cork

ZIP/Postal Code

T12 DFK4

Country

Ireland

Facility Name

GSK Investigational Site

City

Dublin

ZIP/Postal Code

Country

Ireland

Facility Name

GSK Investigational Site

City

Avellino

State/Province

Campania

ZIP/Postal Code

83100

Country

Italy

Facility Name

GSK Investigational Site

City

Napoli

State/Province

Campania

ZIP/Postal Code

80131

Country

Italy

Facility Name

GSK Investigational Site

City

Aviano

State/Province

Friuli-Venezia-Giulia

ZIP/Postal Code

33081

Country

Italy

Facility Name

GSK Investigational Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20122

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20132

Country

Italy

Facility Name

GSK Investigational Site

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20133

Country

Italy

Facility Name

GSK Investigational Site

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20052

Country

Italy

Facility Name

GSK Investigational Site

City

Torrette Di Ancona

State/Province

Marche

ZIP/Postal Code

60126

Country

Italy

Facility Name

GSK Investigational Site

City

Orbassano (TO)

State/Province

Piemonte

ZIP/Postal Code

10043

Country

Italy

Facility Name

GSK Investigational Site

City

Bari

State/Province

Puglia

ZIP/Postal Code

70124

Country

Italy

Facility Name

GSK Investigational Site

City

Catania

State/Province

Sicilia

ZIP/Postal Code

95123

Country

Italy

Facility Name

GSK Investigational Site

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50134

Country

Italy

Facility Name

GSK Investigational Site

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56124

Country

Italy

Facility Name

GSK Investigational Site

City

Legnago (VR)

State/Province

Veneto

ZIP/Postal Code

37045

Country

Italy

Facility Name

GSK Investigational Site

City

Gyeonggi-do

ZIP/Postal Code

463-712

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seongnam-si, Gyeonggi-do

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Suwon-Si

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

GSK Investigational Site

City

Mexico City

State/Province

Ciudad De Mexico

ZIP/Postal Code

06700

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico

State/Province

Ciudad De Mexico

ZIP/Postal Code

03100

Country

Mexico

Facility Name

GSK Investigational Site

City

Naucalpan

State/Province

Estado De México

ZIP/Postal Code

53100

Country

Mexico

Facility Name

GSK Investigational Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64460

Country

Mexico

Facility Name

GSK Investigational Site

City

Mexico City

ZIP/Postal Code

CP 14080

Country

Mexico

Facility Name

GSK Investigational Site

City

Puebla

ZIP/Postal Code

72560

Country

Mexico

Facility Name

GSK Investigational Site

City

Amersfoort

ZIP/Postal Code

3813 TZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Amsterdam

ZIP/Postal Code

1066 CX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Den Bosch

ZIP/Postal Code

5223 GZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Enschede

ZIP/Postal Code

7512 KZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Maastricht

ZIP/Postal Code

6229 HX

Country

Netherlands

Facility Name

GSK Investigational Site

City

Utrecht

ZIP/Postal Code

3543 AZ

Country

Netherlands

Facility Name

GSK Investigational Site

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

GSK Investigational Site

City

Drammen

ZIP/Postal Code

N-3004

Country

Norway

Facility Name

GSK Investigational Site

City

Lørenskog

ZIP/Postal Code

1470

Country

Norway

Facility Name

GSK Investigational Site

City

Oslo

ZIP/Postal Code

N-0450

Country

Norway

Facility Name

GSK Investigational Site

City

Lima

ZIP/Postal Code

Lima 34

Country

Peru

Facility Name

GSK Investigational Site

City

Bialystok

ZIP/Postal Code

15-540

Country

Poland

Facility Name

GSK Investigational Site

City

Lodz

ZIP/Postal Code

93-513

Country

Poland

Facility Name

GSK Investigational Site

City

Olsztyn

ZIP/Postal Code

10-357

Country

Poland

Facility Name

GSK Investigational Site

City

Bucuresti

ZIP/Postal Code

021389

Country

Romania

Facility Name

GSK Investigational Site

City

Bucuresti

ZIP/Postal Code

022328

Country

Romania

Facility Name

GSK Investigational Site

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

GSK Investigational Site

City

Craiova

ZIP/Postal Code

200542

Country

Romania

Facility Name

GSK Investigational Site

City

Iasi

ZIP/Postal Code

700483

Country

Romania

Facility Name

GSK Investigational Site

City

Satu Mare

ZIP/Postal Code

440055

Country

Romania

Facility Name

GSK Investigational Site

City

Timisoara

ZIP/Postal Code

300239

Country

Romania

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

105 229

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

121309

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Nizhniy Novgorod

ZIP/Postal Code

603081

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St. Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

GSK Investigational Site

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

GSK Investigational Site

City

Cordoba

ZIP/Postal Code

140044

Country

Spain

Facility Name

GSK Investigational Site

City

Girona

ZIP/Postal Code

17007

Country

Spain

Facility Name

GSK Investigational Site

City

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

GSK Investigational Site

City

Las Palmas De Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28009

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28027

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

GSK Investigational Site

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Facility Name

GSK Investigational Site

City

Majadahonda (Madrid)

ZIP/Postal Code

28222

Country

Spain

Facility Name

GSK Investigational Site

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

GSK Investigational Site

City

Pamplona

ZIP/Postal Code

31008

Country

Spain

Facility Name

GSK Investigational Site

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

GSK Investigational Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

GSK Investigational Site

City

Gävle

ZIP/Postal Code

SE-801 87

Country

Sweden

Facility Name

GSK Investigational Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

GSK Investigational Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

GSK Investigational Site

City

Lausanne

ZIP/Postal Code

1011

Country

Switzerland

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06010

Country

Turkey

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06520

Country

Turkey

Facility Name

GSK Investigational Site

City

Ankara

ZIP/Postal Code

06680

Country

Turkey

Facility Name

GSK Investigational Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

GSK Investigational Site

City

Istanbul

ZIP/Postal Code

34662

Country

Turkey

Facility Name

GSK Investigational Site

City

Northwood

State/Province

Middlesex

ZIP/Postal Code

HA6 2RN

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Bournemouth

ZIP/Postal Code

BH7 7DW

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

GSK Investigational Site

City

Wrexham

ZIP/Postal Code

LL13 7TD

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing URL

https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Citations:

PubMed Identifier

34478166

Citation

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.

Results Reference

derived

Learn more about this trial

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

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Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-small Cell Lung Cancer (ZEAL-1L)

Lung Cancer, Non-Small Cell

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial