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Clinical Trials/2025-521681-10-00
2025-521681-10-00Not yet recruitingPhase 2

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

Revolution Medicines Inc.41 sites in 9 countries84 target enrollmentStarted: September 22, 2025Last updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Sponsor
Enrollment
84
Locations
41
Primary Endpoint
Confirmed ORR per RECIST v1.1 as assessed by BICR
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the ORR as assessed by RECIST v1.1 criteria of zoldonrasib monotherapy in patients with RAS G12D-mutant NSCLC who have been previously treated with systemic therapy

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Patients that are at least 18 years of age
  • •Patients that have NSCLC with RAS-G12D mutation
  • •Patients that have had cancer treatment before or are not able to tolerate regular treatments.
  • •Patients that have at least 1 measurable tumor (lesion).
  • •Patients that have adequate organ function (bone marrow, liver, kidney) and blood clotting.

Exclusion Criteria

  • •Patients that have primary brain and spinal cord tumor.
  • •Patients thathave gastrointestinal problems that may affect absorption of RMC-9805
  • •Patients thathad any major surgery in the last 4 weeks.
  • •Patients that have any other medical condition that may interfere with the study medicine.
  • •Patient that have a history of severe allergic reactions to the study medicine.
  • •Patients that have previously taken targeted therapy for KRAS mutation.

Outcomes

Primary Outcomes

Confirmed ORR per RECIST v1.1 as assessed by BICR

Confirmed ORR per RECIST v1.1 as assessed by BICR

Secondary Outcomes

  • •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

Investigators

Sponsor
Revolution Medicines Inc.
Sponsor Class
Pharmaceutical company
Responsible Party
Principal Investigator
Principal Investigator

Melanie Caruno

Scientific

Revolution Medicines Inc.

Study Sites (41)

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