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

ConditionLung Neoplasm Malignant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed, previously untreated and surgically resectable non-small cell lung cancer (stage II-IIIA, patients with squamous cell carcinoma or EGFR mutation should not be included);

Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;

Patients approve and sign the informed consent.

Disqualifiers

Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoid carcinoma;

Patients with active autoimmune disease or history of autoimmune disease;

Patients who have a condition requiring systemic treatment with either prednisone or other immunosuppressive medications;

Patients with a history of symptomatic interstitial lung disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • sintilimab

    Drug

    Sintilimab 200 mg, 4 cycles of treatment before surgery

  • bevacizumab

    Drug

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Neoadjuvant treatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Safety (Rate of grade 3 and higher grade treatment-related adverse events)

Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

Time frame
From date of treatment allocation until surgery or up to at least 90 days after last dose of preoperative treatment

Secondary outcomes

1

Feasibility (Completion rate of neoadjuvant treatment and surgery)

Propotion of participants who complete neoadjuvant treatment and receive surgery within 42 days after preoperative therapies.

Time frame
From date of treatment allocation until surgery, assessed up to 5 months
2

Major Pathological Response Rate

Major pathologic response is predefined as no more than 10% of residual viable tumor cells in primary lesions.

Time frame
Two weeks after surgery
3

Radiographic Response

Radiographic response will be evaluated according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

Time frame
From date of treatment allocation and during treatment period up to 4 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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