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Phase 2Recruiting

A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer

Sponsored by Verastem, Inc.

About this study

This study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Non-Small Cell Lung Cancer

Where this study is enrolling (12)

Show all 12 locations
Who can participate

Inclusion criteria

  • ✓Histopathology confirmed unresectable locally advanced or metastatic NSCLC
  • ✓Measurable disease per RECIST 1.1
  • ✓Local testing confirmed KRAS G12D mutation (tissue required for confirmatory central testing)
  • ✓ECOG PS=0 or 1
  • ✓Adequate organ function
  • ✓Received prior treatment with a platinum-based chemotherapy regimen and an immune checkpoint inhibitor in the advanced, non-resectable setting.
  • ✓Have documented disease progression during or following their most recent prior line of therapy.
  • ✓Patients with 2L/3L on stable or preferred dose:
  • ✓Received at least 1 and no more than 2 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
  • ✓Patients with 2L-4L with brain metastases:
  • ✓Received at least 1 and no more than 3 prior systemic lines of therapy for advanced (in the unresectable locally advanced or metastatic setting) NSCLC.
  • ✓Have asymptomatic and untreated brain metastases
  • ✓At least 1 untreated measurable brain lesion per mRECIST v1.1 with a long axis ≥ 0.5 cm and ≤ 3 cm.

Exclusion criteria

  • ✕Have any other documented co-existing common RAS mutation(s)
  • ✕Prior anti-cancer Tx within 4 weeks or drug-specific timeline within first treatment dose, whichever shorter
  • ✕Major surgery within 4 weeks of first treatment dose
  • ✕Radiation therapy (RT) within 1 week of first treatment dose
  • ✕History of drug-induced Interstitial Lung Disease
  • ✕Receipt of prior direct RAS inhibitor
  • ✕Untreated or symptomatic CNS metastasis
  • ✕Receipt of strong CYP3A4 inhibitor/inducer or CYP3A4 sensitive substrates with narrow therapeutic index within 14 days or drug-specific timeline within first treatment dose, whichever is shorter
  • ✕Receipt of PPI or H2 blocker within 5 days
  • ✕Inability to swallow oral medication
  • ✕Other protocol-defined inclusion/exclusion criteria may apply

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.