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Clinical Trials List

Protocol NumberRMC-4630-03
NCT Number(ClinicalTrials.gov Identfier)NCT05054725
Completed

2021-01-01 - 2024-12-31

Phase II

Recruiting5

ICD-10C34.2

Malignant neoplasm of middle lobe, bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.4

Malignant neoplasm of middle lobe, bronchus or lung

A Phase 2, Open-Label, Multicenter Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

  • Sponsor

    Revolution Medicines, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

subjects with KRASG12C mutant NSCLC

Objectives

1. **Primary Objective:** To evaluate the antitumor activity of RMC-4630 in combination with sotorasib in participants with locally advanced or metastatic non–small cell lung cancer (NSCLC) harboring KRAS G12C mutations (with or without co-occurring genomic alterations such as STK11/LKB1, KEAP1, and PIK3CA) who have experienced disease progression following prior standard therapy. 2. **Secondary Objectives:** • To characterize the safety, tolerability, and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in participants with KRAS G12C–mutated NSCLC who have experienced disease progression following prior standard therapy. • To further describe the efficacy profile of RMC-4630 in combination with sotorasib in participants with locally advanced or metastatic KRAS G12C–mutated NSCLC after prior standard therapy, as assessed by duration of response (DOR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). 3. **Exploratory Objectives:** • To explore the relationship between PK parameters and safety and/or efficacy endpoints. • To investigate potential biomarkers through biochemical and/or genomic analyses of blood and/or tumor tissue samples.

Test Drug

RMC-4630 Sotorasib

Active Ingredient

RMC-4630
RMC-4630
Sotorasib

Dosage Form

130

Dosage

MG

Endpoints

Objective Response Rate (ORR) as assessed per RECIST v1.1.

Inclution Criteria

Inclusion Criteria:

Subject must be ≥18 years of age.
Subject must have pathologically documented, locally advanced or metastatic KRASG12C NSCLC (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed)

Exclusion Criteria

Exclusion Criteria

Primary central nervous system (CNS) tumors
Known or suspected leptomeningeal or brain metastases or spinal cord compression
Clinically significant cardiac disease
Known impairment of GI function that would alter the absorption
Active autoimmune disease requiring systemic treatment within past 2 years
History of severe allergic reactions to any of the study intervention components
Major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment.
Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    46 participants

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