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A Phase 1b/2 Open-Label, Multicenter Study of RMC-9805 with or without RMC-6236, in Combination with Other Anticancer Agents, in Patients with RAS G12D-Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol C

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521147-21-00
Acronym
RMC-LUNG-101C
Enrollment
130
Registered
2025-10-06
Start date
2025-10-08
Completion date
Unknown
Last updated
2026-01-14

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

Conditions

Lung Cancer

Brief summary

1. Incidence of DLTs; Part 1 and Part 2 (Cohort C3 safety lead-in only)., 2. Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in vital signs, laboratory test values, and ECGs.

Detailed description

1. Concentrations of RMC-9805 and RMC-6236 (if applicable) in blood over time., 2. ORR and DOR as per RECIST v1.1

Interventions

DRUGPEMBROLIZUMAB
DRUGCARBOPLATIN
DRUGPEMETREXED
DRUGCISPLATIN

Sponsors

Revolution Medicines Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Incidence of DLTs; Part 1 and Part 2 (Cohort C3 safety lead-in only)., 2. Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in vital signs, laboratory test values, and ECGs.

Secondary

MeasureTime frame
1. Concentrations of RMC-9805 and RMC-6236 (if applicable) in blood over time., 2. ORR and DOR as per RECIST v1.1

Countries

Austria, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Spain

Outcome results

None listed

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