NCT07659782 GFH-375 KRAS mutant Non-small Cell Lung Cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready landscape. This focused report examines NCT07659782—A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Non-Small Cell Lung Cancer (TARGET-D 202)—using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, Drug & Asset MCP for mechanism and development context, and Company & Deal Intelligence MCP for sponsor background. Explore PatSnap MCP Servers to reproduce the workflow inside an AI research process.

MCP evidence snapshot: 20 July 2026; publication date: 20 July 2026. Trial records can change after the snapshot and should be rechecked before operational decisions.

Why NCT07659782 is a hot trial to watch

KRAS mutant Non-small Cell Lung Cancer is increasingly segmented by mechanism, biomarker, treatment setting, geography and endpoint architecture. NCT07659782 is notable because it evaluates GFH-375 in a Phase 2 design while Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR) serves as the main decision variable. The critical question is whether the protocol can convert its rationale into a clinically interpretable and operationally credible readout.

PatSnap Clinical Trials MCP makes protocol fields machine-readable, while the companion asset and organization servers add development-status, target and sponsor context.

Trial landscape snapshot

Design and endpoint interpretation

The phase label is only the starting point. Allocation is Randomized, masking is Single, and the intervention model is Crossover Assignment. Planned enrollment of 105 participants across United States shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Primary: Overall Response Rate per RECIST version 1.1, per blinded independent central review (BICR) (6 months)
• Primary: Proportion/number of participants with AEs, TEAEs, TRAEs, SAEs, and dose interruptions/reductions and discontinuations (6 months)
• Secondary: To evaluate additional efficacy parameters of VS-7375 monotherapy administered on a daily oral schedule in participants with KRAS G12D-mutated NSCLC (24 months)
• Secondary: Maximum concentration (Cmax) (20 weeks)
• Secondary: Area under plasma Concentration (AUC) 0 to t (20 weeks)

Benchmark readouts in the surrounding field

• A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant and Adjuvant Tiragolumab Plus Atezolizumab, With or Without Platinum-Based Chemotherapy, in Patients With Previously Untreated Locally Advanced Resectable Stage II, IIIA, or Select IIIB Non-Small Cell Lung Cancer (Phase 2): Number of Participants With Surgical Delays = 0 Participants ; Number of Participants With Surgical Delays = 4 Participants
• A Phase 2, Open-label, Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration-resistant Prostate Cancer and Other Solid Tumors (Phase 2): Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator = 0.69 proportion of participants (95% Confidence Interval, 0.57 - 0.78); Part 1: Six-month Radiographic Progression Free Survival (rPFS) as Determined by the Investigator = 0.70 proportion of participants (95% Confidence Interval, 0.46 - 0.79)
• A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Platinum Plus Pemetrexed Chemotherapy Plus Osimertinib Versus Platinum Plus Pemetrexed Chemotherapy Plus Placebo in Patients With EGFRm, Locally Advanced or Metastatic NSCLC Who Have Progressed Extracranially Following First-Line Osimertinib Therapy (COMPEL) (Phase 3): PFS(Median) = 8.4 Months (95% Confidence Interval, 5.75 - 11.83); PFS(Median): Hazard Ratio (HR) = 0.43(95% CI, 0.27 - 0.70)

These indexed results are contextual benchmarks, not direct head-to-head evidence. Population, treatment line, endpoint definitions, follow-up and analysis sets may differ. Their value is to clarify the type and magnitude of evidence already visible in the competitive landscape.

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Asset and sponsor context

Drug & Asset context: GFH-375 (Phase 3; KRAS G12D)

Company & Deal Intelligence context: Verastem, Inc. — United States — https://www.verastem.com

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can decide whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Sequencing evidence: comparative data after the most relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter probability of success before a headline data release.

Bottom line

NCT07659782 is a focused lens on KRAS mutant Non-small Cell Lung Cancer development. Its value will be determined by whether GFH-375 can convert the current design into evidence that is clinically meaningful, operationally credible and differentiated from indexed benchmark readouts.

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