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

NCT04973293 | Recruiting

• 1 other identifier: RTS-014
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Neoplasm Malignant

Keywords

Non-small cell lung cancer; Neoadjuvant therapy; Immunotherapy

Outcome Measures

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).

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

Secondary Outcomes (3)

• Feasibility (Completion rate of neoadjuvant treatment and surgery)

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

• Major Pathological Response Rate

  Two weeks after surgery

• Radiographic Response

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

Study Arms (1)

Neoadjuvant treatment

EXPERIMENTAL

Participants will receive 4 doses of sintilimab (200 mg, IV) and bevacizumab (15 mg/kg, IV) every 3 weeks (Q3W). Participants will also receive 4 doses of carboplatin (AUC=5, IV) and pemetrexed (500 mg/m2, IV) Q3W. Surgery will be performed within 4 to 6 weeks after completion of preoperative therapy. After the second dose of sintilimab, bevacizumab and chemotherapy, contrast-enhanced chest CT will be performed. Patients with progression disease will receive surgery without the last 2 doses of treatment.

Drug: sintilimab; Drug: bevacizumab

Interventions

sintilimab DRUG

Sintilimab 200 mg, 4 cycles of treatment before surgery

Also known as: IBI308, Xindili Dankang

Neoadjuvant treatment

bevacizumab DRUG

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

Also known as: Bei Fa Zhu Dankang Zhusheye

Neoadjuvant treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• History of allergy to study drug components;
• Women must not be pregnant or breast-feeding;
• Men with female partners that are not willing to use contraception;
• Patients who have received prior chemotherapy, anti-angiogenesis therapy and immunotherapy for this malignancy or for any other past malignancy;
• Patients who have received prior treatment for non-small cell lung cancer;
• Any mental or psychological condition which would not permit the patient to complete the study or understand the patient information;
• Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close to great vessels;
• Patients with high risk of major bleeding;
• Patients who have arterial thrombotic events, esophageal varices, peptic ulcers, wounds or bone fractures;
• Patients who have prior malignancies;
• HIV, HBV, HCV infection or active pulmonary tuberculosis;

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

sintilimab; Bevacizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hecheng Li, MD, PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hecheng Li, MD, PhD

CONTACT

0086-021-64370045; lihecheng2000@hotmail.com

Yuyan Zheng, MD

CONTACT

0086-15280093677; yuyanzheng@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

CN (1)