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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

NCT06977828 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-29

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy works to treat for resectable stage II-IIIB driver gene-negative NSCLC. It will also learn about the safety of tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy.

The main questions it aims to answer are:

1. Does tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy can increase pCR rate as well as MPR rate、EFS、DFS、ORR、OS for resectable stage II-IIIB driver gene-negative NSCLC?
2. Is tislelizumab combined with anlotinib and platinum-based doublet perioperative therapy safe?

Participants with histologically or cytologically confirmed NSCLC, potentially resectable, driver gene negative (II- IIIB stage), and without prior systemic treatment, who have signed the informed consent, will be screened for inclusion. 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 as defined by RECIST 1.1, 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. Survival and safety assessments will be continuously conducted thereafter.

Conditions

  • NSCLC (Non-small Cell Lung Cancer)
  • Neoadjuvant Immunotherapy
  • Adjuvant 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

Sponsors & Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-20
Primary Completion
2027-06-30
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06977828 on ClinicalTrials.gov