Study Details

Open

Phase 3 Study of RMC-6236 in Previously Treated NSCLC Patients with RAS Mutations

The purpose of this study is to test an experimental drug called RMC-6236. RMC-6236 is an experimental drug, which means that it is not approved by the United States (US) Food and Drug Administration (FDA) or any other health authorities. RMC-6236 is currently being investigated in other ongoing studies in non-small cell lung cancer (NSCLC). If you consent and meet the study requirements, you will be randomly assigned to receive either RMC-6236 or docetaxel.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

United States (Nationwide)

What will be asked of you

Your study doctor will tell you if you are in the RMC-6236 treatment group or in the docetaxel treatment group. If you are assigned to the RMC-6236 group during the Treatment Period, you will be responsible for taking the study drug RMC-6236 orally, once a day for 21-days for each treatment cycle. You will also be responsible for recording when you take your study medication tablets in a drug diary. On day 1 of Cycle 2, Cycle 3, and Cycle 5, At each timepoint, about 2.5mL (½ teaspoon) each will be taken (up to 10mL (2 teaspoons) total at these visits). If you are assigned to the docetaxel group, you will receive docetaxel by injection into a vein (intravenously [IV]) once every 3 weeks directly at the study site on Day 1 of a 21-day cycle. On either study arm you will be responsible for completing questionnaires at each visit that evaluate your quality of life and changes in your mental health, physical functioning, and disease-related symptoms. You will also have your heart function tested using an EKG or MUGA scan and you tumor evaluated using a CT or MRI.

Incentives

Study Medication RMC-6236

In-person visits:
11 to 30+

Phone or online visits:
9 Long term follow-up calls

Total length of participation:
4 weeks of prescreening, 15+ weeks of treatment, long term follow-up every 3 months for a year+

Looking for Specific Volunteers

Able to participate:

You have been diagnosed with non small cell lung cancer, either locally advanced or metastatic, where curative surgery or radiotherapy are not viable treatments
You have evidence of progressive disease since your last therapy
Your cancer cells contain certain DNA mutations in the KRAS, NRAS or HRAS genes
You are able to take oral medications and willing to track your usage in a drug diary

Not eligible if:

You have a life expectancy of less than 3 months.
You have had previous RAS-directed therapy
Your cancer cells contain certain gene mutations (EGFR, ALK, ROS1, and BRAF V600E) which have FDA approved therapies
You have significant heart disease, lung disease or impaired function of your stomach or intestine

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Carrie Lee
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Lung)

IRB Number

25-0614

ClinicalTrials.gov

NCT05379985