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RecruitingPhase 2NCT06617936

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

Sponsor

Hua Zhang

Enrollment

36 participants

Start Date

Aug 27, 2024

Study Type

INTERVENTIONAL

Conditions

Unresectable Non-small Cell Lung Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three treatments — tislelizumab (an immunotherapy drug), recombinant human endostatin (a drug that cuts off the blood supply to tumors), and chemotherapy — for patients with stage III non-small cell lung cancer (NSCLC) that cannot be surgically removed. The goal is to see if this triple combination works better than current standard care. **You may be eligible if...** - You are between 18 and 75 years old - You have been confirmed to have stage III NSCLC (squamous or non-squamous) that cannot be surgically removed - This is your first diagnosis (you have not received prior treatment for this cancer) - You are in good general health (ECOG score 0–1) - Your organs are functioning adequately **You may NOT be eligible if...** - You have already received treatment for NSCLC - You have active autoimmune disease - You have certain other serious health conditions or infections - Your tumor has specific genetic mutations (like EGFR or ALK) that have targeted treatments available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGneoadjuvant 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)

PROCEDUREsurgery

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.

DRUGAdjuvant 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.

OTHERStandard 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

Locations(1)

Shandong Public Health Clinical Center (ShandongPHCC)

Jinan, Shandong, China

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NCT06617936