A Phase 1b/2 Open-Label, Multicenter Study of RMC-6236 in Combination with Pembrolizumab with or without Chemotherapy, in Patients with RAS‑Mutated Non-Small Cell Lung Cancer (NSCLC) – Subprotocol B

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509572-42-00

Acronym

RMC-LUNG-101B

Enrollment

180

Registered

2024-06-25

Start date

2024-07-17

Completion date

Unknown

Last updated

2026-01-13

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 2 safety lead-in only), •Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in laboratory test values, ECGs, and vital signs

Detailed description

• Concentrations of RMC-6236 in plasma over time and PK parameters as applicable., • ORR and DOR per RECIST v1.1

Interventions

DRUGPemetrexed Synthon 25 mg/ml

DRUGconcentraat voor oplossing voor infusie

DRUGDARAXONRASIB (RMC-6236)

DRUGPemetrexed Fresenius Kabi 100 mg powder for concentrate for solution for infusion

DRUGCisplatin Hikma 1 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCarboplatin Kabi 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung

DRUGCisplatinum Accord

DRUG1 mg/ml

DRUGkoncentrat do sporządzania roztworu do infuzji.

DRUGCISPLATIN-EBEWE

DRUG1 MG/ML

DRUGKONCENTRAT DO SPORZĄDZANIA ROZTWORU DO INFUZJI

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGCARBOPLATIN-EBEWE

DRUG10 MG/ML

DRUGCARBO-cell® 10 mg/ml Infusionslösung

DRUGKonzentrat zur Herstellung einer Infusionslösung

DRUGPemetrexed STADA 25 mg/ml Konzentrat zur Herstellung einer Infusionslösung

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
• Concentrations of RMC-6236 in plasma over time and PK parameters as applicable., • ORR and DOR per RECIST v1.1	—

Countries

France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

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