A Phase 2, Open-Label, Multicenter Study of Zoldonrasib(RMC-9805) in Previously Treated Patients with RAS G12DMutant Non-Small Cell Lung Cancer (NSCLC) – Subprotocol D

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521681-10-00

Acronym

RMC-LUNG-101D

Enrollment

Registered

2025-09-22

Start date

2025-10-02

Completion date

Unknown

Last updated

2025-12-11

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

Conditions

Lung Cancer

Brief summary

Confirmed ORR per RECIST v1.1 as assessed by BICR

Detailed description

•PFS, • OS, • DOR, • TTR, • DCR, • PFS rate at 6 months and 12 months and OS rate at 12 months, • Incidence of TEAEs, SAEs, and changes from baseline in clinical laboratory values and vital signs., • Zoldonrasib blood concentration over time

Interventions

DRUGRMC-9805

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Confirmed ORR per RECIST v1.1 as assessed by BICR	—

Secondary

Measure	Time frame
•PFS, • OS, • DOR, • TTR, • DCR, • PFS rate at 6 months and 12 months and OS rate at 12 months, • Incidence of TEAEs, SAEs, and changes from baseline in clinical laboratory values and vital signs., • Zoldonrasib blood concentration over time	—

Countries

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

Outcome results

None listed

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