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Non-Small Cell Lung CancerPhase 2TARGET-D 202NCT07659782

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

A Phase 2 study testing VS-7375 in people with Non-Small Cell Lung Cancer, run by Verastem, Inc. at 24 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
VS-7375
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
24 sitesin 3 countries
Study dates
22 Jul 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 13Show fewer
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

24 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Verastem Call Center contact

7812924204

VS-7375-202TrialSupport@verastem.com

Ting Wu, MD contact

VS-7375-202Medical@verastem.com

24 sites in 3 countries

United States19 sites, 19 recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Lily Goggans, 404-778-5087, lily.goggans@emory.edu

    Jennifer Carlisle, MD

    Recruiting

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

    Scott Bowman, 303-724-6624, scott.s.bowman@cuanschutz.edu

    Tejas Patil, MD

    Recruiting

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Rebecca Rambharose, (919) 966-4432, Rebecca_Rambharose@med.unc.edu

    Elyse Schmidt, (919) 966-7809, elyse_schmidt@med.unc.edu

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Christopher Clemens, 434-297-8854, JCC4DT@uvahealth.org

    Richard Hall, MD

    Recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    cancerclinicaltrials@bsd.uchicago.edu, cancerclinicaltrials@bsd.uchicago.edu

    Marina Garassino, MD

    Recruiting

  • BRCR Global - Coral Springs

    Coral Springs, Florida, 33065

    Valeria Lasciche, 561-447-0614, valerial@brcrglobal.com

    Sumit Sawhney, MD

    Recruiting

  • START New Jersey

    East Brunswick, New Jersey, 08816

    Emily Lichtenstein, 7324264750, emily.lichtenstein@startresearch.com

    Bruno Fang, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Morgan Foy, 703-208-3192, morgan.foy@usoncology.com

    Alexander Spira, MD

    Recruiting

  • START Fort Worth

    Fort Worth, Texas, 76104

    Hope Team, 6823503010, hopeteam@startresearch.com

    Salwan Almutar, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Tammie Carter, TKCarter@mdanderson.org

    Marcelo Negrao, MD

    Recruiting

  • START LA

    Los Angeles, California, 90025

    Hope Team Distribution List, 4244651820, hopeteam@startresearch.com

    Navid Hafez, MD

    Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

    Group Cancer Trial Information, GroupCancerTrialInformation@cshs.org

    Karen Reckamp, MD

    Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067

    Matthew Nguyen, 424 535 1874, Matthew.nguyen@vctcare.com

    David Berz, MD

    Recruiting

  • NYU

    New York, New York, 10016

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

    Rajwanth Veluswamy, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Robert Dyson, dysonr@mskcc.org

    Kathryn Arbour, MD

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84112

    Shantae George, 801-213-8486, shantae.george@hci.utah.edu

    Matthew Gumbleton, MD

    Recruiting

  • HonorHealth Research Institute

    Scottsdale, Arizona, 85258

    Amy Stoll D'astice, 480-323-1350, astolldastice@honorhealth.com

    Frank Tsai, MD

    Recruiting

  • BRCR Global- Tamarac

    Tamarac, Florida, 33321

    Diana Casas, (561) 4470614, dianac@brcrglobal.com

    Andrew Schneider, MD

    Recruiting

  • Moffit Cancer Centre

    Tampa, Florida, 33612

    Sereina Barakat, 813-745-4673, Sereina.barakat@moffitt.org

    Andreas Saltos, MD

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • ICON Cancer Centre South Brisbane

    Brisbane, Queensland, 4101

    Apryl Chelin, 07 3737 4757, Apryl.chelin@icon.team

    Jermaine Coward, MD

    Recruiting

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

    Hannah Prsa, +61 2 8514 0274, Hannah.Prsa@lh.org.au

    Malinda Itchins, MD

    Recruiting

  • Macquarie University Hospital

    Sydney, New South Wales, 2109

    Cameron Hardy, +61 481 468 029, cameron.hardy@mq.edu.au

    John Park, MD

    Recruiting

Other trials in Australia

Puerto Rico2 sites, 2 recruiting

  • BRCR Global- San Juan

    San Juan, 00907

    Edward Morales, 939 419 1158, edwardm@brcrglobal.com

    Alexandra Deya, MD

    Recruiting

  • BRCR Global- Yauco

    Yauco, 00698

    Edward Morales, N/S, edwardm@brcrglobal.com

    Maryknoll De La Paz, Md

    Recruiting

Other trials in Puerto Rico

About this study

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)

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

Being tested
VS-7375
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VS-7375Drug

    Taken by mouth

Study groups in NCT07659782
Study groupRoleWhat they receive
VS-7375 Monotherapy 2L/3LExperimental2L/3L VS-7375 dose
Receives: Drug: VS-7375
VS-7375 Monotherapy 2L/3L Preferred DoseExperimental2L/3L Preferred VS-7375 dose
Receives: Drug: VS-7375
2L-4L with brain metastasisExperimental2L-4L VS-7375 dose
Receives: Drug: VS-7375

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 months

  2. 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

    Measured: 6 months

Secondary outcomes (6)

  1. 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

    Measured: 24 months

  2. Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, Cmax

    Maximum concentration (Cmax)

    Measured: 20 weeks

  3. Plasma Pharmacokinetics (PK) of VS-7375 and relevant metabolites, AUC

    Area under plasma Concentration (AUC) 0 to t

    Measured: 20 weeks

  4. To evaluate Pharmacodynamics (PD) and other relevant blood tumor markers specific to tumor type

    CA19-9, CEA, CA-125

    Measured: Up to 2.5 years

  5. 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

    Measured: 24 months

  6. Time to next therapy

    To assess the interval between initiation of study treatment and initiation of subsequent treatment

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start22 Jul 2026
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07659782
Sponsor's protocol ID
VS-7375-202
Other IDs
2026-526472-23-00
Acronym
TARGET-D 202
Status last verified
Jul 2026
First submitted
15 Jun 2026
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VS-7375 in people with Non-Small Cell Lung Cancer, run by Verastem, Inc. at 24 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Verastem Call Center (7812924204, VS-7375-202TrialSupport@verastem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed ORR by blinded independent central review (BICR) per RESIST v1.1 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07659782.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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