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OncoMatch/Clinical Trials/NCT06855771

A Study of Navlimetostat (BMS-986504) Alone or in Combination With Izalontamab Brengitecan in Participants With Pre-treated Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Homozygous MTAP Deletion or MTAP Loss (MountainTAP-9)

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

Is NCT06855771 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies multiple treatments including BMS-986504 and Izalontamab Brengitecan for carcinoma, non-small-cell lung.

Phase 2RecruitingBristol-Myers SquibbNCT06855771Data as of Oct 2026Location: International · 12 countries

Treatment: BMS-986504 · Izalontamab Brengitecan — The purpose of this study is to evaluate the safety and efficacy of Navlimetostat (BMS-986504) monotherapy or in combination with Izalontamab Brengitecan in participants with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) with homozygous MTAP deletion or MTAP loss after progression on prior therapies.

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Extracted eligibility criteria

Treatments studied

Other

BMS-986504Izalontamab Brengitecan

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: MTAP homozygous deletion

homozygous MTAP deletion detected in tumor tissue and willingness to provide archival/fresh samples at screening for central MTAP status confirmation

Required: MTAP loss

homozygous MTAP deletion or MTAP loss

Allowed: EGFR any tested

Participants with EGFR mutant or wild type NSCLC are allowed

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy — advanced or metastatic NSCLC

Documented radiographic disease progression on or after the most recent line of treatment

Cannot have received: PRMT5 inhibitor

Prior treatment with a PRMT5 ... inhibitor

Cannot have received: MAT2A inhibitor

Prior treatment with a ... MAT2A inhibitor

Cannot have received: antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload

Exception: except amivantamab

Prior therapy with iza-bren or any other antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload, except amivantamab

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Local Institution - 0088 · Anchorage, Alaska
  • Dana-Farber Cancer Institute · Boston, Massachusetts
  • Karmanos Cancer Institute · Detroit, Michigan
  • Washington University School of Medicine · St Louis, Missouri
  • Memorial Sloan Kettering Cancer Center · New York, New York

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06855771 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior PRMT5 inhibitor, MAT2A inhibitor, antibody and/or ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload disqualifies patients from enrollment.

Does this trial require MTAP?

Yes, MTAP homozygous deletion is a required biomarker for enrollment.

Does this trial require MTAP?

Yes, MTAP loss is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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