Health Trials

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

ConditionMetastatic Non-small Cell Lung Cancer With MTAP Deletion
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986504

    Drug

    Specified dose on specified days

  • Pembrolizumab

    Drug

    Specified dose on specified days

  • Placebo

    Other intervention

    Specified dose on specified days

  • Cisplatin

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Pemetrexed

    Drug

    Specified dose on specified days

  • Paclitaxel

    Drug

    Specified dose on specified days

  • Nab-paclitaxel

    Drug

    Specified dose on specified days

Treatment groups

590 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Arm A: BMS-986504 + Pembrolizumab + ChemotherapyActive comparator 7 interventions
Group B: Arm B: BMS-986504 + Pembrolizumab + ChemotherapyActive comparator 7 interventions
Group C: Arm C: Placebo + Pembrolizumab + ChemotherapyPlacebo comparator 7 interventions
Group D: Arm D: Placebo + Pembrolizumab + ChemotherapyPlacebo comparator 7 interventions
Group E: Arm E: BMS-986504 + Pembrolizumab + ChemotherapyActive comparator 7 interventions
Group F: Arm F: Placebo + Pembrolizumab + ChemotherapyPlacebo comparator 7 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS) by RECIST v1.1

Phase 2

Time frame
Up to 2 years
2

PFS by RECIST v1.1 per BICR

Phase 3

Time frame
Up to 5 years
3

Overall Survival (OS)

Phase 3

Time frame
Up to 5 years

Secondary outcomes

1

Objective response (OR) (confirmed complete response (CR) or partial response (PR))

Phase 2

Time frame
Up to 2 years
2

Disease control (best overall response (BOR) of confirmed CR, confirmed PR, or stable disease (SD))

Phase 2

Time frame
Up to 2 years
3

Duration of response (DOR) (CR or PR)

Phase 2

Time frame
Up to 2 years
4

Time to objective response (TTOR) (CR or PR)

Phase 2

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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