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

NCT ID: NCT04973293

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2025-12-31

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.

Detailed 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.

Conditions

Lung Neoplasm Malignant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Neoadjuvant treatment

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.

Group Type: EXPERIMENTAL

sintilimab

Intervention Type: DRUG

Sintilimab 200 mg, 4 cycles of treatment before surgery

bevacizumab

Intervention Type: DRUG

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

Interventions

sintilimab

Sintilimab 200 mg, 4 cycles of treatment before surgery

Intervention Type: DRUG

bevacizumab

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

Intervention Type: DRUG

Other Intervention Names

IBI308; Xindili Dankang; Bei Fa Zhu Dankang Zhusheye

Eligibility Criteria

Inclusion Criteria

1. 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);

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

3. Satisfactory preoperative laboratory testing and adequate pulmonary function for surgery;

4. Patients approve and sign the informed consent.

Exclusion Criteria

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

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

3. Patients who have a condition requiring systemic treatment with either prednisone or other 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 and immunotherapy 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 complete the study or understand the patient information;

11. Patients who have major hemoptysis within the past 4 weeks, tumor has invasion or is close 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 the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hecheng Li M.D., Ph.D

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hecheng Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hecheng Li, MD, PhD

Role: CONTACT

lihecheng2000@hotmail.com

0086-021-64370045

Yuyan Zheng, MD

Role: CONTACT

yuyanzheng@outlook.com

0086-15280093677

Facility Contacts

Hecheng Li, MD,PHD

Role: primary

lihecheng2000@hotmail.com

0086-021-64370045

Yuyan Zheng, MD

Role: backup

yuyanzheng@outlook.com

0086-15280093677

Other Identifiers

RTS-014

Identifier Type: -

Identifier Source: org_study_id