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

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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Key information

Conditions

Lung Cancer (NSCLC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Surgical resection

Procedure

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

Primary outcomes

Major Pathological Response Rate

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

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2030
First posted: Sep 21, 2026
Registry last updated: Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Not yet recruiting