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Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study | Clinical Trials | Clareo Health

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Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study

A Randomized, Double-Blind, Phase III Study of Platinum+Pemetrexed Chemotherapy With or Without Pembrolizumab (MK-3475) in First Line Metastatic Non-squamous Non-small Cell Lung Cancer Subjects (KEYNOTE-189)

NCT03950674•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This is a Japan Extension Study of Global Study MK-3475-189 (NCT02578680). This is an efficacy and safety study of pembrolizumab (MK-3475) combined with pemetrexed/platinum chemotherapy versus pemetrexed/platinum chemotherapy alone in adult Japanese participants with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have not previously received systemic therapy for advanced disease. Participants will be randomly assigned to receive pembrolizumab combined with pemetrexed/platinum (Investigators choice of cisplatin or carboplatin), OR pemetrexed/platinum (Investigators choice of cisplatin or carboplatin). With Amendment 11 (effective date 31-Jan-2022), once the study objectives have been met or the study has ended, participants will be discontinued from this study and will be enrolled in an extension study to continue protocol-defined assessments and treatment. The primary hypothesis is that pembrolizumab in combination with pemetrexed/platinum chemotherapy prolongs Progression-Free Survival (PFS) and Overall Survival (OS) compared to pemetrexed/platinum chemotherapy alone.

Detailed Description

The MK-3475-189-Japan Extension Study will be identical to the global study (e.g. inclusion and exclusion criteria, study primary and secondary outcome measures and study procedures). The MK-3475-189-Japanese Extension Study enrolled a total of 30 participants and the analyses included 10 participants (pembrolizumab =4; control = 6) that had been previously enrolled in the MK-3475-189 global study (NCT02578680), resulting in a total of 40 participants.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Has a histologically-confirmed or cytologically confirmed diagnosis of stage IV nonsquamous NSCLC.
•Has confirmation that epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated.
•Has measurable disease.
•Has not received prior systemic treatment for their advanced/metastatic NSCLC.
•Can provide tumor tissue.
•Has a life expectancy of at least 3 months.
•Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.
•Has adequate organ function
•If female of childbearing potential, is willing to use adequate contraception for the course of the study through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.
•If male with a female partner(s) of child-bearing potential, must agree to use adequate contraception starting with the first dose of study medication through 120 days after the last dose of study medication or through 180 days after last dose of chemotherapeutic agents.

Exclusion Criteria

•Has predominantly squamous cell histology NSCLC.
•Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to administration of pembrolizumab.
•Before the first dose of study medication: a) Has received prior systemic cytotoxic chemotherapy for metastatic disease, b) Has received antineoplastic biological therapy (e.g. erlotinib, crizotinib, cetuximab), c) Had major surgery (\<3 weeks prior to first dose)
•Received radiation therapy to the lung that is \>30 Gray (Gy) within 6 months of the first dose of study medication.
•Completed palliative radiotherapy within 7 days of the first dose of study medication.
•Is expected to require any other form of antineoplastic therapy while on study.
•Received a live-virus vaccination within 30 days of planned start of study medication.
•Has clinically active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, peritoneal carcinomatosis.
•Known history of prior malignancy except if participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy, except for successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
+15 more criteria

Locations (10)

National Hospital Organization Nagoya Medical Center ( Site 0324)

Nagoya, Aichi-ken, Japan

Kurume University Hospital ( Site 0326)

Kurume, Fukuoka, Japan

Hyogo Cancer Center ( Site 0325)

Akashi, Hyōgo, Japan

Kanazawa University Hospital ( Site 0328)

Kanazawa, Ishikawa-ken, Japan

Kansai Medical University Hospital ( Site 0313)

Hirakata, Osaka, Japan

Shizuoka Cancer Center Hospital and Research Institute ( Site 0322)

Sunto-gun, Shizuoka, Japan

National Hospital Organization Shikoku Cancer Center ( Site 0303)

Matsuyama, Japan

Okayama University Hospital ( Site 0327)

Okayama, Japan

National Cancer Center Hospital ( Site 0301)

Tokyo, Japan

The Cancer Institute Hospital of JFCR ( Site 0323)

Tokyo, Japan

Key Dates

Start Date

February 22, 2016

Primary Completion Date

May 20, 2019

Completion Date

June 22, 2023

Last Updated

June 10, 2024

Enrollment

ACTUAL participants

Conditions

Non-Small-Cell Lung Carcinoma

Interventions

Pembrolizumab 200 mg

BIOLOGICAL

Cisplatin

DRUG

Carboplatin

DRUG

Pemetrexed

DRUG

Folic acid 350-1000 μg

DIETARY_SUPPLEMENT

Vitamin B12 1000 μg

DIETARY_SUPPLEMENT

Dexamethasone 4 mg

DRUG

Saline solution

DRUG

Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context

NCT06487078

ALK+ Non-Small-Cell Lung Carcinoma

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ACTIVE_NOT_RECRUITINGNA

Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study

NCT06461338

Non-small Cell Lung CancerNon-Small-Cell Lung Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Pemetrexed+Platinum Chemotherapy With or Without Pembrolizumab (MK-3475) in Participants With First Line Metastatic Nonsquamous Non-small Cell Lung Cancer (MK-3475-189/KEYNOTE-189)-Japan Extension Study

Inclusion Criteria

Exclusion Criteria

Analysis of the Effectiveness and Safety of Lorlatinib in Untreated ALK-Positive NSCLC Patients in a French Real-World Context

Acupuncture for Enhancing Immunotherapy in Advanced NSCLC：a Pilot Study

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