NCT06977828

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

Not yet recruiting Phase 2 Last updated 29 June 2025

What this trial tests

Phase 2 trial testing tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy in NSCLC (Non-small Cell Lung Cancer) in 40 participants. Not yet recruiting.

Timeline

20 July 2025

Primary endpoint
30 June 2027

31 December 2028

Quick facts

Lead sponsor	The First Affiliated Hospital with Nanjing Medical University
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	20 July 2025
Primary completion	30 June 2027
Estimated completion	31 December 2028
Sites	1 location across China

Drugs / interventions tested

• tislelizumab in combination with anlotinib and platinum-based doublet chemotherapy — full drug profile →

Conditions studied

• NSCLC (Non-small Cell Lung Cancer) — all drugs for NSCLC (Non-small Cell Lung Cancer) →
• Neoadjuvant Immunotherapy — all drugs for Neoadjuvant Immunotherapy →
• Adjuvant Immunotherapy — all drugs for Adjuvant Immunotherapy →

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Who can join

Adults 18 to 75, any sex, with NSCLC (Non-small Cell Lung Cancer) or Neoadjuvant Immunotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.