Perioperative Targeted Therapy in Resectable or Potentially Resectable Stage III Non-small Cell Lung Cancer With Rare Driver Mutations

NCT07829744 — Phase 2, Not yet recruiting, 190 participants, Shanghai Zhongshan Hospital

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Registry	NCT07829744
Status	Not yet recruiting
Phase	Phase 2
Study type	Interventional; non randomized, parallel, masking: none, treatment
Enrollment	190 (Estimated)
Sponsor	Shanghai Zhongshan Hospital (Other)
Conditions	Lung Cancer (NSCLC)
Interventions	Surgical Resection (Procedure)
Dates	start 2026-09-20 (estimated), primary completion 2030-06-30 (estimated), completion 2030-06-30 (estimated), first posted 2026-09-21, last updated 2026-09-21

-Summary

This study evaluates the effectiveness and safety of targeted therapy given before and after surgery in patients with resectable or potentially resectable stage III non-small cell lung cancer with selected genetic alterations. Treatment is assigned according to tumor genetic findings.

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+Arms and interventions

Arm	Type	Interventions	Description
EGFR Exon 20 Insertion Cohort	Experimental	Procedure: Surgical Resection	Sunvozertinib
ALK Fusion Cohort	Experimental	Procedure: Surgical Resection	Alectinib
ROS1 Fusion Cohort	Experimental	Procedure: Surgical Resection	Entrectinib
MET Exon 14 Skipping Cohort	Experimental	Procedure: Surgical Resection	Tepotinib
RET Fusion Cohort	Experimental	Procedure: Surgical Resection	Selpercatinib
KRAS G12C Mutation Cohort	Experimental	Procedure: Surgical Resection	Fulzerasib

Surgical Resection (Procedure): Curative-intent resection following targeted therapy in participants considered suitable for surgery.

+Outcome measures

Primary outcomes

Major Pathological Response Rate [At surgery, approximately 10-12 weeks after treatment initiation.]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Age ≥18 years.
* Histologically or cytologically confirmed stage III NSCLC (AJCC 8th edition), considered resectable or potentially resectable.
* Documented EGFR exon 20 insertion, ALK fusion, ROS1 fusion, MET exon 14 skipping alteration, RET fusion, or KRAS G12C mutation.
* At least one measurable lesion per RECIST 1.1 and ECOG performance status 0-1.
* Adequate cardiopulmonary and major organ function for surgery.
* Written informed consent and willingness to comply with study procedures, sample collection, and follow-up.

Exclusion Criteria:

* Stage III NSCLC considered unresectable by surgical assessment.
* Lung cancer treatment within the previous 2 years, or prior lung cancer with a remission duration of less than 2 years.
* Another malignancy within the previous 5 years.
* Major surgery within 28 days before the first study dose.
* Any contraindication to the assigned targeted therapy.
* Inability or unwillingness to provide informed consent or comply with study requirements.