NCT06617936

Tislelizumab Combined With Recombinant Human Endostatin Combined With Chemotherapy for Unresectable Stage III Non-small Cell Lung Cancer.

Tislelizumab Combined With Recombinant Human Endostatin Injection Plus Chemotherapy in Unresectable Stage III NSCLC: a Prospective, Single-arm, Multicenter Phase II Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Hua Zhang · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, multicenter, phase II clinical study designed to evaluate the initial efficacy and safety of patients receiving Tislelizumab in combination with recombinant human endostatin injection plus chemotherapy for stage III unresectable non-small cell lung cancer. To evaluate the surgical conversion rate of tirellizumab combined with recombinant human endostatin injection and chemotherapy induction therapy in patients with initially unresectable stage III non-small cell lung cancer.

Conditions

• Unresectable Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	neoadjuvant therapy:Tislelizumab With Recombinant human endostatin combined with Chemotherapy	neoadjuvant therapy : Tislelizumab: 200mg, ivgtt, day 1 ; Recombinant Human Endostatin Injection (Endostar),210mg was pumped intravenously for 3 consecutive days; Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC):Pemetrexed: 500 mg/m\^2, ivgtt, day 1. Nab-paclitaxel: 260mg/m\^2, ivgtt, day 1.; Carboplatin:Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 ivgtt on day 1 ; every 21 days for 1 cycle,2-4 cycles; (If the preoperative neoadjuvant did not reach 4 cycles, the treatment with ralizumab combined with recombinant human endostatin injection and chemotherapy for 1-2 cycles can be continued after surgery, and the total cycle of chemotherapy before and after surgery is up to 4 cycles)
PROCEDURE	surgery	Patients who are discussed by the MDT panel to evaluate surgical resection will undergo surgery.Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.
DRUG	Adjuvant therapy:Tislelizumab and Recombinant Human Endostatin Injection (Endostar)	Adjuvant therapy Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, 17 cycles at most. Recombinant Human Endostatin Injection (Endostar):210mg was pumped intravenously for 3 consecutive days, every 21 days for 1 cycle,17 cycles at most.
OTHER	Standard Treatment	Patients assessed by the MDT panel as inoperable for surgical treatment will be selected by the investigator for a standard treatment protocol determined by the MDT discussion

Timeline

• Start date: 2024-08-27
• Primary completion: 2026-09-10
• Completion: 2027-09-10
• First posted: 2024-10-01
• Last updated: 2025-07-15

Locations

1 site across 1 country: China