NCT07492342 Fulzerasib Resectable Lung Non-Small Cell Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07492342 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.
MCP evidence snapshot: 26 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07492342 is a hot trial to watch
Resectable Lung Non-Small Cell Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07492342 is notable because it evaluates Fulzerasib in a Phase 2 design sponsored by The First Affiliated Hospital of Guangzhou Medical University. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07492342 |
| Official title | Fulzerasib Sequential Sintilimab Plus Platinum-Doublet Neoadjuvant Therapy for Resectable KRAS G12C-Mutant NSCLC (K-NADIR) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Fulzerasib |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University |
| Geography | China |
| Enrollment | not reported |
| Primary endpoint | Pathological Complete Response, pCR |
| Endpoint time frame | At the time of definitive surgery |
| Primary completion / readout proxy | not reported |
Protocol design and endpoint interpretation
This is an exploratory study evaluating the efficacy and safety of neoadjuvant therapy with fulzerasib sequentially combined with sintilimab plus platinum-doublet chemotherapy in patients with resectable non-small cell lung cancer (NSCLC) harboring KRAS G12C mutation. Approximately 30 treatment-naïve patients with stage IB-IIIA (AJCC 8th edition) NSCLC and confirmed KRAS G12C mutation will be enrolled. Eligible subjects will receive 6 weeks of fulzerasib followed by a 2-week washout period, then 3 cycles (q3w) of sintilimab plus investigator's choice of platinum-doublet chemotherapy. An end-of-treatment visit will be performed within 7 days after the last dose of neoadjuvant therapy.
Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment was not reported; study geography in China 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.
- Pathological Complete Response, pCR(At the time of definitive surgery) — The proportion of patients with no residual invasive tumor in the primary tumor and all sampled lymph nodes, as assessed by histopathological examination of the resected surgical specimen.
Readout outlook and evidence gap
The current protocol points to not reported as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.
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Asset and sponsor context
Drug & Asset MCP profile: Fulzerasib is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.
Company & Deal Intelligence MCP profile: The First Affiliated Hospital of Guangzhou Medical University is resolved to a normalized organization record in Guangzhou, China. The organization workflow adds identity, location, portfolio and partnering context where available.
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 determine 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.
- Comparator relevance: evidence against the most decision-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 the probability of success before a headline data release.
Bottom line
NCT07492342 provides a focused lens on Resectable Lung Non-Small Cell Carcinoma development. Its value will be determined by whether Fulzerasib can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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