What this study is
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
What's being tested
- VS-7375
Intervention · DRUG
Taken by mouth
Study details
- Official title
- 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)
- Sponsor
- Verastem, Inc.
- Conditions
- Non-Small Cell Lung Cancer
- Enrolling
- 105 people
- Starts
- 2026-07-22
- Est. completion
- 2028-12
- Design
- Single-blind, randomized, crossover, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (24)
24 openHonorHealth Research Institute
Scottsdale, Arizona, United States
- Amy Stoll D'astice · Contact480-323-1350astolldastice@honorhealth.com
- Frank Tsai, MD · Principal investigator
RecruitingSTART LA
Los Angeles, California, United States
- Hope Team Distribution List · Contact4244651820hopeteam@startresearch.com
- Navid Hafez, MD · Principal investigator
RecruitingCedars-Sinai Medical Center
Los Angeles, California, United States
- Group Cancer Trial Information · ContactGroupCancerTrialInformation@cshs.org
- Karen Reckamp, MD · Principal investigator
RecruitingValkyrie Clinical Trials
Los Angeles, California, United States
- Matthew Nguyen · Contact424 535 1874Matthew.nguyen@vctcare.com
- David Berz, MD · Principal investigator
RecruitingUniversity of Colorado Cancer Center
Aurora, Colorado, United States
- Scott Bowman · Contact303-724-6624scott.s.bowman@cuanschutz.edu
- Tejas Patil, MD · Principal investigator
RecruitingBRCR Global - Coral Springs
Coral Springs, Florida, United States
- Valeria Lasciche · Contact561-447-0614valerial@brcrglobal.com
- Sumit Sawhney, MD · Principal investigator
RecruitingBRCR Global- Tamarac
Tamarac, Florida, United States
- Diana Casas · Contact(561) 4470614dianac@brcrglobal.com
- Andrew Schneider, MD · Principal investigator
RecruitingMoffit Cancer Centre
Tampa, Florida, United States
- Sereina Barakat · Contact813-745-4673Sereina.barakat@moffitt.org
- Andreas Saltos, MD · Principal investigator
RecruitingEmory Winship Cancer Institute
Atlanta, Georgia, United States
- Lily Goggans · Contact404-778-5087lily.goggans@emory.edu
- Jennifer Carlisle, MD · Principal investigator
RecruitingUniversity of Chicago
Chicago, Illinois, United States
- cancerclinicaltrials@bsd.uchicago.edu · Contactcancerclinicaltrials@bsd.uchicago.edu
- Marina Garassino, MD · Principal investigator
RecruitingSTART New Jersey
East Brunswick, New Jersey, United States
- Emily Lichtenstein · Contact7324264750emily.lichtenstein@startresearch.com
- Bruno Fang, MD · Principal investigator
RecruitingNYU
New York, New York, United States
- Mark Bond · Contact646-754-7217Mark.Bond@nyulangone.org
- Rajwanth Veluswamy, MD · Principal investigator
RecruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
- Robert Dyson · Contactdysonr@mskcc.org
- Kathryn Arbour, MD · Principal investigator
RecruitingUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
- Rebecca Rambharose · Contact(919) 966-4432Rebecca_Rambharose@med.unc.edu
- Elyse Schmidt · Contact(919) 966-7809elyse_schmidt@med.unc.edu
- Shetal Patel, MD, PhD · Principal investigator
RecruitingSTART Fort Worth
Fort Worth, Texas, United States
- Hope Team · Contact6823503010hopeteam@startresearch.com
- Salwan Almutar, MD · Principal investigator
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
- Abigail Burroughs · ContactASBurroughs@mdanderson.org
- Marcelo Negrao, MD · Principal investigator
RecruitingUniversity of Utah
Salt Lake City, Utah, United States
- Shantae George · Contact801-213-8486shantae.george@hci.utah.edu
- Matthew Gumbleton, MD · Principal investigator
RecruitingUniversity of Virginia
Charlottesville, Virginia, United States
- Christopher Clemens · Contact434-297-8854JCC4DT@uvahealth.org
- Richard Hall, MD · Principal investigator
RecruitingVirginia Cancer Specialists
Fairfax, Virginia, United States
- Morgan Foy · Contact703-208-3192morgan.foy@usoncology.com
- Alexander Spira, MD · Principal investigator
Recruiting
5 sites outside the US
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
- Hannah Prsa · Contact+61 2 8514 0274Hannah.Prsa@lh.org.au
- Malinda Itchins, MD · Principal investigator
RecruitingMacquarie University Hospital
Sydney, New South Wales, Australia
- Cameron Hardy · Contact+61 481 468 029cameron.hardy@mq.edu.au
- John Park, MD · Principal investigator
RecruitingICON Cancer Centre South Brisbane
Brisbane, Queensland, Australia
- Apryl Chelin · Contact07 3737 4757Apryl.chelin@icon.team
- Jermaine Coward, MD · Principal investigator
RecruitingBRCR Global- San Juan
San Juan, Puerto Rico
- Edward Morales · Contact939 419 1158edwardm@brcrglobal.com
- Alexandra Deya, MD · Principal investigator
RecruitingBRCR Global- Yauco
Yauco, Puerto Rico
- Edward Morales · ContactN/Sedwardm@brcrglobal.com
- Maryknoll De La Paz, Md · Principal investigator
Recruiting
Study team
Sponsor
Verastem, Inc.
Study ID VS-7375-202
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.