A Multicenter, Randomized, Open-label, Phase 2 Study Evaluating the Safety and Efficacy of BMS-986504 Monotherapy in Participants with Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) with Homozygous MTAP Deletion After Progression on Prior Therapies

Cancer Categories

Lung

Karmanos Trial ID

2025-053

NCT ID

NCT06855771

Age Group

Adult

Scope

National

Phase

Phase II

Principal Investigator

Dipesh
Uprety, M.D.
Oncology - Medical View Profile

Objective:

Part 1: Dose Selection

Primary Objective:

To evaluate investigator-assessed objective response (OR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level

Secondary Objectives:

To evaluate investigator-assessed disease control (DC) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level
To evaluate investigator-assessed clinical benefit (CB) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level
To evaluate investigator-assessed duration of response (DOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level
To evaluate investigator-assessed progression-free survival (PFS) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level
To evaluate investigator-assessed time to objective response (TTOR) of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level
To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion by dose level
Part 2 + Selected Dose from Part 1

Primary Objective:

To evaluate OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

Secondary Objectives:

To evaluate investigator-assessed OR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate investigator-assessed DC of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate investigator-assessed CB of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate investigator-assessed PFS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate investigator-assessed TTOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To evaluate investigator-assessed DOR of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To assess OS of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To assess the safety and tolerability of BMS-986504 in participants with advanced or metastatic NSCLC with homozygous MTAP deletion
To assess the impact of disease symptoms and treatment on participant’s healthrelated quality-of-life in participants with advanced or metastatic NSCLC with homozygous MTAP deletion

Request an Appointment

Refer a Patient

NCI Dictionary of Cancer Terms

KCI Clinical Trials App

Eligibility

Inclusion Criteria:

Histologically confirmed diagnosis of NSCLC and homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation.
Advanced or metastatic NSCLC not amenable to curative therapies after progression on prior therapies at the time of enrollment (based on the American Joint Committee on Cancer, Ninth Edition).
At least 1 measurable lesion as per RECIST v1.1.
Documented radiographic disease progression on or after the most recent line of treatment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participant must be ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place) at the time of signing the ICF.
Capability to swallow tablets intact (without chewing or crushing).

Exclusion Criteria:

Active brain metastases or carcinomatous meningitis.
History of gastrointestinal disease or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications.
Prior treatment with a PRMT5 or MAT2A inhibitor.
Known severe hypersensitivity to study treatment and/or any of its excipients.

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
Get Directions

Phone: 1-800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions

Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices