A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer
Key facts
- Where
- Chemnitz, Essen, Esslingen am Neckar, and Munich, GermanySee the 4 sites
- Phase
- Phase 2
Where in Germany
- Klinikum Chemnitz gGmbHChemnitz, GermanyNot yet recruiting
- KEM I Evang. Kliniken Essen-Mitte gGmbHEssen, GermanyNot yet recruiting
- Klinikum Esslingen GmbHEsslingen am Neckar, GermanyNot yet recruiting
- TUM School Of Medicine And HealthMunich, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Verastem, Inc.
- Trial code
- NCT07659782EU 2026-526472-23-00
- Record updated
- 6 November 2026
- Original description
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 CancerRead full original descriptionShow less
A Phase 2, Open-label Study of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients With Previously Treated, Advanced KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)
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
Inclusion: 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: 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; Receipt of prior direct RAS inhibitor; 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; Inability to swallow oral medication; History of drug-induced Interstitial Lung Disease; Have any other documented co-existing common RAS mutation(s); Untreated or symptomatic CNS metastasis; Receipt of PPI or H2 blocker within 5 days; Other protocol-defined inclusion/exclusion criteria may apply.