A Phase 2 interventional study of VS-7375 in Non-Small Cell Lung Cancer, sponsored by Verastem, Inc.. Recruiting at 19 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Verastem, Inc. · Phase 2, Interventional, and Treatment
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
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's planned enrollment of 105 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Verastem, Inc. is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with 2L/3L on stable or preferred dose:
Patients with 2L-4L with brain metastases:
Exclusion Criteria:
2L/3L VS-7375 dose
Drug: VS-7375
2L/3L Preferred VS-7375 dose
Drug: VS-7375
2L-4L VS-7375 dose
Drug: VS-7375
Taken by mouth
Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1
Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR)
Time frame: 6 months
To characterize the safety and tolerability of VS-7375 monotherapy administered on a daily oral schedule in participants with KRAS G12D-mutated NSCLC
Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions/reductions and discontinuations
Time frame: 6 months
Confirmed ORR per RECIST v1.1 assessed by BICR (primary) and Investigator (secondary) assessments
To evaluate additional efficacy parameters of VS-7375 monotherapy administered on a daily oral schedule in participants with KRAS G12D-mutated NSCLC
Time frame: 24 months
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax
Maximum concentration (Cmax)
Time frame: 20 weeks
Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC
Area under plasma Concentration (AUC) 0 to t
Time frame: 20 weeks
To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type
CA19-9, CEA, CA-125
Time frame: Up to 2.5 years
To assess the health-related quality of life and disease based on European Organization for Research and Treatment of Cancer (EORTC) Quality of life Questionnaire Core module C30 (QLQ-C30)
The EORTC QLQ-C30 is a validated questionnaire to assess the quality of life of non-small cell lung cancer patients
Time frame: 24 months
Time to next therapy
To assess the interval between initiation of study treatment and initiation of subsequent treatment
Time frame: 24 months
Imaging of tumor metabolism changes
To assess tumor metabolism dynamics on FDG-PET/CT
Time frame: 24 months
Plan to share: Yes
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Carcinoma, Non-Small-Cell Lung→
Verastem, Inc.