RecruitingNot ApplicableNCT04973293

Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Resectable Non-Small Cell Lung Cancer

The Safety and Feasibility of Preoperative Sintilimab Combined With Bevacizumab and Chemotherapy for Locally Advanced Resectable Non-Small Cell Lung Cancer


Sponsor

Ruijin Hospital

Enrollment

20 participants

Start Date

Oct 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Neoadjuvant chemotherapy followed by surgery has been recommended as the standard treatment for locally advanced and resectable non-small cell lung cancer (NSCLC). However, its efficacy remains to be improved. Drugs targeting PD-1/PD-L1 pathway have been proven to be effective for late-stage NSCLC, and anti-angiogenesis agents targeting VEGF (bevacizumab) has also been used for the first line treatment of advanced or metastatic NSCLC. Therefore, we conduct this single-arm clinical trial, which aims to investigate the safety and feasibility of neoadjuvant sintilimab combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding the immunotherapy drug sintilimab and bevacizumab (an anti-blood vessel drug) to standard chemotherapy before surgery can improve results for people with resectable (operable) non-small cell lung cancer. **You may be eligible if...** - You have been newly diagnosed with non-small cell lung cancer (NSCLC) at stage II or IIIA, confirmed by biopsy or tissue analysis - You have adenocarcinoma (a specific subtype of NSCLC) without an EGFR mutation - Your cancer is considered surgically removable - You are in good physical condition (ECOG 0–1) with adequate lung function for surgery - You have not previously received any treatment for this cancer **You may NOT be eligible if...** - You have squamous cell carcinoma, large-cell carcinoma, sarcomatoid carcinoma, or a Pancoast tumour - You have an EGFR mutation - You have an active autoimmune disease or are on immunosuppressive therapy - You have a history of severe immune-related side effects from prior immunotherapy 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

DRUGsintilimab

Sintilimab 200 mg, 4 cycles of treatment before surgery

DRUGbevacizumab

bevacizumab 15 mg/kg, 4 cycles of treatment before surgery


Locations(1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

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NCT04973293


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