KRAS G12D-mutant non-small cell lung cancer: test VS-7375 alone and with cetuximab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 trial evaluates the safety and potential effectiveness of VS-7375 as a single agent and in combination with cetuximab for adults with unresectable or metastatic NSCLC carrying a KRAS G12D mutation. Participants must have measurable disease, confirmed KRAS G12D, and have progressed after platinum-based chemotherapy and immune checkpoint inhibitor therapy. The study includes patients with 2L/3L NSCLC and, for those with brain metastases, specific criteria such as asymptomatic status and limited prior therapies. Primary assessments focus on safety, with secondary measures likely including tumor response and duration of benefit. Locations include centers in Arizona and California, led by Verastem, Inc.

Why it matters

Who can join: the full rules

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

Where it's running

• HonorHealth Research Institute
  Scottsdale, Arizona, United States Recruiting
• Start la
  Los Angeles, California, United States Recruiting
• Cedars-Sinai Medical Center
  Los Angeles, California, United States Recruiting
• Valkyrie Clinical Trials
  Los Angeles, California, United States Recruiting
• University of Colorado Cancer Center
  Aurora, Colorado, United States Recruiting
• BRCR Global - Coral Springs
  Coral Springs, Florida, United States Recruiting

Study contacts

• Study coordinator: Verastem Call Center
• Email: VS-7375-202TrialSupport@verastem.com
• Phone: 7812924204

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.