Recruiting

Phase 2

Phase 3

BMS-986504 & PembrolizumabA 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

Sponsor:

Bristol-Myers Squibb

Code:

NCT07063745

Conditions

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BMS-986504

Pembrolizumab

Placebo

Cisplatin

Carboplatin

Study Details

Brief summary:

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

Conditions

Metastatic Non-small Cell Lung Cancer With MTAP Deletion

Study ID

NCT07063745

Start date

Jan 2, 2026

Status verified date

Aug, 2026

Completion date

Aug 12, 2031

Anticipated

Primary completion date

Aug 12, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

590 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Arm A: BMS-986504 + Pembrolizumab + Chemotherapy

active comparator: Arm B: BMS-986504 + Pembrolizumab + Chemotherapy

placebo comparator: Arm C: Placebo + Pembrolizumab + Chemotherapy

placebo comparator: Arm D: Placebo + Pembrolizumab + Chemotherapy

active comparator: Arm E: BMS-986504 + Pembrolizumab + Chemotherapy

placebo comparator: Arm F: Placebo + Pembrolizumab + Chemotherapy

Interventions

BMS-986504