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

September 15, 2026 updated by: Shanghai Zhongshan Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGFR Exon 20 Insertion Cohort

Sunvozertinib
Procedure: Surgical Resection

Curative-intent resection following targeted therapy in participants considered suitable for surgery.
Experimental: ALK Fusion Cohort

Alectinib
Procedure: Surgical Resection

Curative-intent resection following targeted therapy in participants considered suitable for surgery.
Experimental: ROS1 Fusion Cohort

Entrectinib
Procedure: Surgical Resection

Curative-intent resection following targeted therapy in participants considered suitable for surgery.
Experimental: MET Exon 14 Skipping Cohort

Tepotinib
Procedure: Surgical Resection

Curative-intent resection following targeted therapy in participants considered suitable for surgery.
Experimental: RET Fusion Cohort

Selpercatinib
Procedure: Surgical Resection

Curative-intent resection following targeted therapy in participants considered suitable for surgery.
Experimental: KRAS G12C Mutation Cohort

Fulzerasib
Procedure: Surgical Resection

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major Pathological Response Rate
Time Frame: At surgery, approximately 10-12 weeks after treatment initiation.
At surgery, approximately 10-12 weeks after treatment initiation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2026

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

September 15, 2026

First Submitted That Met QC Criteria

September 15, 2026

First Posted (Actual)

September 21, 2026

Study Record Updates

Last Update Posted (Actual)

September 21, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2026-011R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe