Recruiting

Phase 2

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

Sponsor:

Verastem, Inc.

Code:

NCT07659782

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VS-7375

Study Details

Brief summary:

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

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07659782

Start date

Jul 22, 2026

Status verified date

Jul, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

VS-7375

Taken by mouth

Primary outcome measure

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 [ 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 [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Verastem Call Center

7812924204 VS-7375-202TrialSupport@verastem.com

Ting Wu, MD

VS-7375-202Medical@verastem.com

Locations

START LA

Recruiting

Los Angeles, California, United States, 90025

Contacts

Hope Team Distribution List

4244651820 hopeteam@startresearch.com

Principal Investigator:

Navid Hafez, MD

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Stephanie Pirucki

424-314-0882 stephanie.pirucki@cshs.org

Principal Investigator:

Karen Reckamp, MD

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90067

Contacts

Matthew Nguyen

424 535 1874 Matthew.nguyen@vctcare.com

Principal Investigator:

David Berz, MD

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Lily Goggans

404-778-5087 lily.goggans@emory.edu

Principal Investigator:

Jennifer Carlisle, MD

START New Jersey

Recruiting

East Brunswick, New Jersey, United States, 08816

Contacts

Emily Lichtenstein

7324264750 emily.lichtenstein@startresearch.com

Principal Investigator:

Bruno Fang, MD

NYU

Recruiting

New York, New York, United States, 10016

Contacts

Mark Bond

646-754-7217 Mark.Bond@nyulangone.org

Principal Investigator:

Rajwanth Veluswamy, MD

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Robert Dyson

dysonr@mskcc.org

Principal Investigator:

Kathryn Arbour, MD

START Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Hope Team

6823503010 hopeteam@startresearch.com

Principal Investigator:

Salwan Almutar, MD

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Tammie Carter

TKCarter@mdanderson.org

Principal Investigator:

Marcelo Negrao, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Christopher Clemens

434-297-8854 JCC4DT@uvahealth.org

Principal Investigator:

Richard Hall, MD

More Information

Sponsor

Verastem, Inc.

Last update posted

Sep 4, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Verastem, Inc. on 2026-09-04.