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

NCT07829744 | Not Yet Recruiting Phase 2

• 1 other identifier: B2026-011R
• Study Type: interventional
• Target: 190
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Major Pathological Response Rate

  At surgery, approximately 10-12 weeks after treatment initiation.

Study Arms (6)

EGFR Exon 20 Insertion Cohort

EXPERIMENTAL

Sunvozertinib

Procedure: Surgical Resection

ALK Fusion Cohort

EXPERIMENTAL

Alectinib

Procedure: Surgical Resection

ROS1 Fusion Cohort

EXPERIMENTAL

Entrectinib

Procedure: Surgical Resection

MET Exon 14 Skipping Cohort

EXPERIMENTAL

Tepotinib

Procedure: Surgical Resection

RET Fusion Cohort

EXPERIMENTAL

Selpercatinib

Procedure: Surgical Resection

KRAS G12C Mutation Cohort

EXPERIMENTAL

Fulzerasib

Procedure: Surgical Resection

Interventions

Surgical Resection PROCEDURE

Curative-intent resection following targeted therapy in participants considered suitable for surgery.

ALK Fusion Cohort; EGFR Exon 20 Insertion Cohort; KRAS G12C Mutation Cohort; MET Exon 14 Skipping Cohort; RET Fusion Cohort; ROS1 Fusion Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: September 21, 2026

Record last verified: 2026-09