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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.

Description

This is a phase 2 multicenter, open-label study evaluating the efficacy, safety, tolerability and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in subjects with KRASG12C mutant NSCLC after failure of prior standard therapies.

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this trial is to determine the objective response rate.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet this 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)

Excluding patients who meet this 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 two 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 a seven days of treatment.
  • Prior therapy with KRASG12C inhibitor and/or SHP2 inhibitor

     

Accepting new patients

 

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