A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Purpose
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
Condition
- Non-Small Cell Lung Cancer
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental VS-7375 Monotherapy 2L/3L |
2L/3L VS-7375 dose |
|
|
Experimental VS-7375 Monotherapy 2L/3L Preferred Dose |
2L/3L Preferred VS-7375 dose |
|
|
Experimental 2L-4L with brain metastasis |
2L-4L VS-7375 dose |
|
Recruiting Locations
START LA
Los Angeles, California 90025
Los Angeles, California 90025
START New Jersey
East Brunswick, New Jersey 08816
East Brunswick, New Jersey 08816
More Details
- Status
- Recruiting
- Sponsor
- Verastem, Inc.