Recruiting NCT07063745

A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Phase II / Phase III Interventional Metastatic Non-small Cell Lung Cancer With MTAP Deletion

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BMS-986504, Pembrolizumab, Placebo, Cisplatin.
Who it may be relevant to: Registry conditions: Metastatic Non-small Cell Lung Cancer With MTAP Deletion. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +29
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Phase 2/3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion

Overview

The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion

Interventions

Drug BMS-986504
Specified dose on specified days
Drug Pembrolizumab
Specified dose on specified days
Other Placebo
Specified dose on specified days
Drug Cisplatin
Specified dose on specified days
Drug Carboplatin
Specified dose on specified days
Drug Pemetrexed
Specified dose on specified days
Drug Paclitaxel
Specified dose on specified days
Drug Nab-paclitaxel
Specified dose on specified days

Primary outcome measures

Progression-free survival (PFS) by RECIST v1.1 [Time frame: Up to 2 years]
PFS by RECIST v1.1 per BICR [Time frame: Up to 5 years]
Overall Survival (OS) [Time frame: Up to 5 years]

Secondary outcome measures (12)

Objective response (OR) (confirmed complete response (CR) or partial response (PR)) [Time frame: Up to 2 years]
Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD)) [Time frame: Up to 2 years]
Duration of response (DOR) (CR or PR) [Time frame: Up to 2 years]
Time to objective response (TTOR) (CR or PR) [Time frame: Up to 2 years]
Number of participants with treatment-related and all-cause adverse events (AEs) [Time frame: Up to 90 days from the last dose]
Number of participants with serious adverse events (SAEs) including fatal AEs [Time frame: Up to 90 days from the last dose]
Number of participants with adverse events leading to dose interruption, dose reduction, and study treatment discontinuation [Time frame: Up to 90 days from the last dose]
Number of participants with laboratory abnormalities [Time frame: Up to 90 days from the last dose]
OR (confirmed CR or PR) [Time frame: Up to 5 years]
Disease control (BOR of confirmed CR, confirmed PR, or SD) [Time frame: Up to 5 years]
DOR (CR or PR) [Time frame: Up to 5 years]
PFS by RECIST v1.1 per Investigator [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participants must have at least 1 measurable lesion as per RECIST v1.1.

Exclusion criteria

Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
Participants must not have symptomatic brain metastases or spinal cord compression.
Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).

Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.

Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.
Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment