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Study of RMC-6291, With or Without RMC-6236, in Combination With Other Anti-Cancer Agents, in Patients With RAS G12C-Mutated Non-Small Cell Lung Cancer – Subprotocol A

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509571-16-00
Acronym
RMC-LUNG-101A
Enrollment
162
Registered
2024-06-17
Start date
2024-07-17
Completion date
Unknown
Last updated
2025-12-17

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

Conditions

Lung Cancer

Brief summary

• Incidence of DLTs (Part 1 and Part 2 Cohort A2, A3 and A4 safety lead-in only) •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs

Detailed description

RMC-6291 plasma concentrations overtime and PK parameters as applicable. RMC-6291 plasma and RMC-6236 blood concentration over time and PK parameters as applicable • ORR and DOR per RECIST v1.1

Interventions

DRUGPemetrexed STADA 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGPemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion
DRUGRMC-6236
DRUGCisplatinum Accord
DRUG1 mg/ml
DRUGkoncentrat do sporządzania roztworu do infuzji.
DRUGCARBOPLATIN-EBEWE
DRUG10 MG/ML
DRUGKONCENTRAT DO SPORZĄDZANIA ROZTWORU DO INFUZJI
DRUGCARBO-cell® 10 mg/ml Infusionslösung
DRUGKonzentrat zur Herstellung einer Infusionslösung
DRUGCisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung
DRUGRMC-6291
DRUGCISPLATIN-EBEWE
DRUG1 MG/ML
DRUGPemetrexed Synthon 25 mg/ml
DRUGconcentraat voor oplossing voor infusie
DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Sponsors

Revolution Medicines Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Secondary

MeasureTime frame
RMC-6291 plasma concentrations overtime and PK parameters as applicable. RMC-6291 plasma and RMC-6236 blood concentration over time and PK parameters as applicable • ORR and DOR per RECIST v1.1—

Primary

MeasureTime frame
• Incidence of DLTs (Part 1 and Part 2 Cohort A2, A3 and A4 safety lead-in only) •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs—

Countries

France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

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