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

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT07659782

Run by

Verastem, Inc.

People needed

105

Starts

2026-07-22

Expected to finish

2028-12-01

Last updated by the study team

2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• START LA — Los Angeles, California, United States (enrolling)
• START New Jersey — East Brunswick, New Jersey, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• START Fort Worth — Fort Worth, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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