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RecruitingPhase 2

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 2 study tests how safe VS-7375 is and how well it works, alone or with cetuximab. It is for people with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12D gene change. Other study rules may also apply.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have NSCLC confirmed by a tissue test that cannot be removed by surgery and has spread nearby or to other parts of the body. The cancer must be measurable on scans.
  • Have a KRAS G12D gene change confirmed by local testing. A tissue sample is needed for another test by the study team.
  • Be fully active or able to do light work, and have organs that work well enough.
  • Have already received platinum-based chemotherapy and an immune checkpoint inhibitor, a drug that helps the immune system fight cancer, for advanced cancer that cannot be removed by surgery. The cancer must have worsened during or after the most recent treatment.
  • For the stable or preferred dose group: have received 1 or 2 prior rounds of treatment plans that act throughout the body for advanced NSCLC.
  • For the brain spread group: have received 1 to 3 prior treatment plans that act throughout the body for advanced NSCLC.
  • For the brain spread group: have untreated cancer in the brain that causes no symptoms. At least one untreated brain tumor must measure 0.5 to 3 cm across its longest part.

Who can't join

  • Have another common RAS gene change, or have previously received a drug that directly blocks RAS.
  • Have received cancer treatment within 4 weeks before the first study dose, or within a shorter time set for that drug.
  • Have had major surgery within 4 weeks, or radiation within 1 week, before the first study dose.
  • Have a history of drug-caused interstitial lung disease, which can inflame or scar the lungs.
  • Have untreated cancer or cancer causing symptoms in the brain or spinal cord. This conflicts with the brain spread group's rules above; ask the study team which rule applies.
  • Have recently taken certain medicines that affect a liver enzyme called CYP3A4, or certain medicines it breaks down that need tightly controlled doses. The limit is 14 days before the first study dose, or a shorter time set for that drug.
  • Have taken a proton pump inhibitor (PPI) or H2 blocker, medicines that lower stomach acid, within 5 days.
  • Cannot swallow medicine.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (19)

AZ

CA

CO

FL

GA

IL

NC

NJ

NY

TX

UT

VA