RightFit
RecruitingPhase 3

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares daraxonrasib (RMC-6236), a drug that blocks RAS, with docetaxel to see how safe it is and how well it works. It is for adults with advanced non-small cell lung cancer (NSCLC) that has certain RAS gene changes and has already been treated.

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older and has agreed to join after learning about the study.
  • Fully active or able to do light work, even if heavy activity is limited.
  • Has NSCLC confirmed by lab testing that has spread nearby or to other parts of the body and cannot be cured with surgery or radiation.
  • Has cancer that can be measured using standard study rules.
  • Has good enough bone marrow, liver, kidney, and blood-clotting function.
  • Has had 1 or 2 courses of cancer treatment, including platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 drug, which helps the immune system fight cancer.
  • Has a documented KRAS, NRAS, or HRAS gene change at position 12, 13, or 61 that changes the RAS protein.
  • Can take medicine by mouth.

Who can't join

  • Has already had a drug that directly targets RAS or has had docetaxel.
  • Has untreated cancer spread to the brain or spinal cord.
  • Has serious other health problems, such as heart or blood vessel disease, lung disease, or problems with how the digestive system works.
  • Is currently receiving cancer treatment.
  • Is pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy. * Measurable disease per RECIST v1.1. * Adequate organ function (bone marrow, liver, kidney, coagulation). * One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy. * Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61). * Able to take oral medications. Exclusion Criteria: * Prior therapy with direct RAS-targeted therapy or docetaxel. * Untreated central nervous system (CNS) metastases. * Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function). * Ongoing anticancer therapy. * Pregnant or breastfeeding.

Study sites (45)

AL

CA

CT

FL

GA

IA

IL

KS

MD

MI

MO

MT

NC

NH

NJ

NY

OH

OR

PA

SD

TN

TX

UT

VA