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

Last updated: November 16, 2024
Sponsor: Ruijin Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasms

Treatment

sintilimab

bevacizumab

Clinical Study ID

NCT04973293
RTS-014
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

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

  3. Satisfactory preoperative laboratory testing and adequate pulmonary function forsurgery;

  4. Patients approve and sign the informed consent.

Exclusion

Exclusion Criteria:

  1. Pancoast tumor, squamous cell carcinoma, large-cell carcinoma and sarcomatoidcarcinoma;

  2. Patients with active autoimmune disease or history of autoimmune disease;

  3. Patients who have a condition requiring systemic treatment with either prednisone orother immunosuppressive medications;

  4. Patients with a history of symptomatic interstitial lung disease;

  5. History of allergy to study drug components;

  6. Women must not be pregnant or breast-feeding;

  7. Men with female partners that are not willing to use contraception;

  8. Patients who have received prior chemotherapy, anti-angiogenesis therapy andimmunotherapy for this malignancy or for any other past malignancy;

  9. Patients who have received prior treatment for non-small cell lung cancer;

  10. Any mental or psychological condition which would not permit the patient to completethe study or understand the patient information;

  11. Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or isclose to great vessels;

  12. Patients with high risk of major bleeding;

  13. Patients who have arterial thrombotic events, esophageal varices, peptic ulcers,wounds or bone fractures;

  14. Patients who have prior malignancies;

  15. HIV, HBV, HCV infection or active pulmonary tuberculosis;

  16. Underlying medical conditions that, in the Investigator's opinion, will make theadministration of study drug hazardous or obscure the interpretation of toxicity oradverse events.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: sintilimab
Phase:
Study Start date:
October 01, 2022
Estimated Completion Date:
December 31, 2025

Study Description

Lung cancer is one of the most common malignancies around the world. 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. Bevacizumab targeting VEGF is a widely used antitumor drugs in different types of malignancies, including late-stage NSCLC. Immune checkpoint inhibitor (ICI) targeting PD-1 has also been confirmed to be effective in NSCLC patients. Therefore, we conduct this prospective single-arm clinical trial, to investigate the safety and feasibility of neoadjuvant sintilimab (ICI targeting PD-1) combined with bevacizumab and chemotherapy followed by surgery in treating locally advanced and resectable NSCLC. Twenty patients with stage II-IIIA NSCLC will be enrolled. And the primary endpoint of this study is the safety of this newly developed neoadjuvant treatment. The secondary endpoints are feasibility, radiological response and rate of major pathological response.

Connect with a study center

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

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