New pill targets Hard-to-Treat lung cancer mutation
NCT ID NCT07659782
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 15 times
Summary
This trial tests an experimental daily pill, VS-7375, for people with advanced non-small cell lung cancer that has a specific genetic change called KRAS G12D. Participants must have already tried chemotherapy and an immunotherapy drug. The study looks at whether the drug can shrink tumors and how safe it is, both when used alone and with another cancer medicine.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VS-7375 (an oral KRAS G12D inhibitor)
- What this could lead to
- If successful, this could offer a new targeted treatment option for people with a specific type of advanced lung cancer that has not responded to prior therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants. The drug may not shrink tumors or may cause side effects. Results may not apply to all patients.
Why investors are watching
Verastem is a very small company, so this phase 2 trial of its oral drug VS-7375 in advanced KRAS G12D-mutated lung cancer is a major test of its pipeline. The trial measures disease control and safety, both alone and with cetuximab, in 105 patients who have already had treatment. A clear result matters because this drug could become a core product for a company of this size.
If it works: If VS-7375 shows good disease control and a tolerable safety profile, Verastem could advance the drug toward later-stage testing and potentially secure partnerships or funding. That outcome would validate its main research program and give the company a path forward.
If it fails: The trial could fail to show meaningful benefit or produce safety problems, which would set the program back and hurt a micro-cap company with few other options. Phase 2 trials often fail, so a negative result is a real possibility.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 105 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cedars-Sinai Medical Center
RECRUITINGLos Angeles, California, 90048, United States
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Chris O'Brien Lifehouse
RECRUITINGCamperdown, New South Wales, 2050, Australia
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Emory Winship Cancer Institute
RECRUITINGAtlanta, Georgia, 30322, United States
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ICON Cancer Centre South Brisbane
RECRUITINGBrisbane, Queensland, 4101, Australia
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Macquarie University Hospital
RECRUITINGSydney, New South Wales, 2109, Australia
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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NYU
RECRUITINGNew York, New York, 10016, United States
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START Fort Worth
RECRUITINGFort Worth, Texas, 76104, United States
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START LA
RECRUITINGLos Angeles, California, 90025, United States
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START New Jersey
RECRUITINGEast Brunswick, New Jersey, 08816, United States
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University of Virginia
RECRUITINGCharlottesville, Virginia, 22908, United States
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Valkyrie Clinical Trials
RECRUITINGLos Angeles, California, 90067, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two-Drug combo targets stubborn KRAS lung cancer
- Smaller chest drain may speed recovery after lung cancer surgery
- Gut bacteria may hold clues to why some cancer treatments work better
- Breath-Tracking sensor aims to sharpen lung cancer scans
- Can PET scan signals predict who beats lung cancer with immunotherapy?
- Two-Drug combo takes aim at Hard-to-Treat lung cancer