A Prospective, Single-arm, Phase II Clinical Study of Tislelizumab Combined With Anlotinib and Platinum-based Doublet Perioperative Therapy for Resectable Stage II-IIIB Driver Gene-negative NSCLC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 20, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

December 31, 2028

Conditions
NSCLC (Non-small Cell Lung Cancer)Neoadjuvant ImmunotherapyAdjuvant Immunotherapy
Interventions
DRUG

tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy

After receiving 4 cycles of tislelizumab combined with anlotinib and platinum-based doublet chemotherapy, the subjects will be evaluated by a multidisciplinary team (MDT) to determine whether to proceed with radical surgical resection. The surgery will be performed within 3 to 7 weeks after the last neoadjuvant treatment. Postoperatively, patients will be divided into two subgroups based on the pathological results: For patients with postoperative pathological pCR, tislelizumab monotherapy will be used for maintenance treatment; For patients with postoperative pathological non-pCR, tislelizumab combined with anlotinib will be used for maintenance treatment. Both groups will continue treatment until disease progression, intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor therapy, death, or other situations specified in the protocol that require treatment cessation, whichever occurs first. The maximum treatment duration is 12 months

Trial Locations (1)

210029

The First Affiliated Hospital of Nanjing Medical University, Nanjing

All Listed Sponsors
lead

The First Affiliated Hospital with Nanjing Medical University

OTHER