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Clinical Trials List

Protocol NumberRMC-6236-301

Active

2025-05-01 - 2030-12-01

Phase III

Recruiting5

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

RASolve 301: A phase 3, multicenter, open-label, randomized trial comparing RMC-6236 with Docetaxel in patients with treated locally advanced or metastatic RAS (MUT) NSCLC.

Trial Applicant

IQVIA RDS Taiwan Ltd.
Sponsor

IQVIA Co., Ltd.
Trial scale

Multi-Regional Multi-Center
Update

2026/08/03

Investigators and Locations

Principal Investigator Chien-Chung Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Jen Yang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chao-Hua Chiu 無

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 柯皓文

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

• PFS is defined as the time elapsed from randomization to disease progression or death from any cause (whichever occurs first). Disease progression is assessed by the trial administrator according to RECIST v1.1.

Objectives

Compare the therapeutic effects of RMC-6236 and Docetaxel in the RAS (G12X-C) population.

Test Drug

Docetaxel AqVida 20 mg/ml concentrate for solution for infusion
RMC-6236

Active Ingredient

DOCETAXEL
RMC-6236
RMC-6236

Dosage Form

Infusion fluid
tablets

Dosage

160mg/8ml
20 mg
100 mg

Endpoints

• PFS is defined as the time elapsed from randomization to disease progression or death from any cause (whichever occurs first). Disease progression is assessed by the trial administrator according to RECIST v1.1.

Inclution Criteria

1. Must be 18 years of age or older and have provided informed consent.

2. ECOG performance status 0 or 1.

3. Histologically confirmed locally advanced or metastatic NSCLC, unsuitable for radical surgery or radiation therapy.

4. Measurable disease according to RECIST v1.1.

5. Adequate organ function (bone marrow, liver, kidneys, coagulation function).

6. One or two prior therapies, including anti-PD-1/anti-PD(L)-1 drugs and platinum-based chemotherapy.

7. Documented RAS mutation status, defined as a non-synonymous mutation in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).

8. Able to take oral medications.

9. For a complete list of inclusion criteria, please refer to the program document.

Exclusion Criteria

1. Previous treatment directly targeting the RAS or Docetaxel treatment.

2. Untreated central nervous system (CNS) metastases.

3. Clinically significant comorbidities (severe cardiovascular disease, lung disease, or impaired gastrointestinal function).

4. Currently undergoing anticancer treatment.

5. Pregnancy or breastfeeding.

6. Please refer to the proposal for a complete list of exclusion criteria.

The Estimated Number of Participants

Taiwan

13 participants
Global

420 participants