A Multicenter Phase II Randomized Trial of Limertinib Followed by Sintilimab and Chemotherapy vs. Limertinib Followed by Limertinib and Chemotherapy as Neoadjuvant Therapy in Resectable Stage II-IIIB EGFR-Mutant NSCLC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

July 31, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2029

Conditions
Resectable Non-small Cell Lung Cancer
Interventions
DRUG

Limertinib+sintilimab+chemotherapy

Experimental group patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, experimental group patients discontinue therapy for 1 week, then receive Sintilimab + Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles.

DRUG

Limertinib+chemotherapy

Control group group patients receive Limertinib for 6 weeks. Within 7 days thereafter, imaging assessment will be performed. If no progression is observed, control group patients receive Lilotinib for next 9 weeks + Carboplatin/Cisplatin + Pemetrexed every 3 weeks for 3 cycles.

PROCEDURE

surgery

The surgical procedure may involve minimally invasive surgery (video-assisted thoracoscopic surgery, robot-assisted surgery) or open thoracotomy. The surgical methods include lobectomy, combined lobectomy, pneumonectomy, sleeve resection, and ipsilateral systematic mediastinal lymph node dissection (for left-sided tumors, stations 4L, 5, 6, 7, and 9 should be included; for right-sided tumors, at least stations 2R, 3A, 4R, 7, and 9 should be included).

DRUG

Osimertinib

Adjuvant treatment with Osimertinib for 2 years

Trial Locations (6)

Unknown

Affiliated Cancer Hospital and Institute of Guangzhou Medical Univercity, Guangzhou

Guangdong Province People's Hospital, Guangzhou

Sun Yet-Sen University Cancer Center, Guangzhou

Hunan Cancer Hospital, Changsha

Xiangya Hospital Central South University, Changsha

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

All Listed Sponsors
lead

Wen-zhao ZHONG

OTHER