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

RecruitingPhase 2

Sponsor: Verastem, Inc.

Conditions: Non-Small Cell Lung Cancer

Interventions: VS-7375

Countries: United States, Australia

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (7)

Los Angeles, California, United States
Los Angeles, California, United States
Atlanta, Georgia, United States
East Brunswick, New Jersey, United States
New York, New York, United States
Fort Worth, Texas, United States
Brisbane, Queensland, Australia