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A Randomized Phase 2/3 Study of 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

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521511-40-00
Acronym
CA240-0029
Enrollment
191
Registered
2025-10-24
Start date
2025-11-18
Completion date
Unknown
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastatic non-small cell lung cancer

Brief summary

Phase 2: Progression free survival (PFS) by RECIST v1.1, Phase 3: Progression free survival (PFS) by RECIST v1.1, Phase 3: overall survival (OS).

Detailed description

Phase 2: objective response (OR), disease control (DC), time to objective response (TTOR), and duration of response (DOR)by RECIST v1.1, Phase 3: objective response (OR), disease control (DC), time to objective response (TTOR), duration of response (DOR), progression free survival (PFS) and PFS2 by RECIST v1.1, Phase 2: Treatment-related and all-cause adverse events (AEs), serious AEs (including fatal AEs); AEs leading to dose interruption, dose reduction, and study treatment discontinuation and laboratory abnormalities

Interventions

DRUGCARBOPLATIN
DRUGCISPLATIN
DRUGPEMETREXED
DRUGPACLITAXEL ALBUMIN-BOUND
DRUGPEMBROLIZUMAB
DRUGPACLITAXEL

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Phase 2: Progression free survival (PFS) by RECIST v1.1, Phase 3: Progression free survival (PFS) by RECIST v1.1, Phase 3: overall survival (OS).

Secondary

MeasureTime frame
Phase 2: objective response (OR), disease control (DC), time to objective response (TTOR), and duration of response (DOR)by RECIST v1.1, Phase 3: objective response (OR), disease control (DC), time to objective response (TTOR), duration of response (DOR), progression free survival (PFS) and PFS2 by RECIST v1.1, Phase 2: Treatment-related and all-cause adverse events (AEs), serious AEs (including fatal AEs); AEs leading to dose interruption, dose reduction, and study treatment discontinuation and laboratory abnormalities

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Romania, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026