Back to results

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

Primary Purpose

Lung Neoplasm Malignant

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

sintilimab

bevacizumab

About this trial

This is an interventional treatment trial for Lung Neoplasm Malignant focused on measuring Non-small cell lung cancer, Neoadjuvant therapy, Immunotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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;
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.

Sites / Locations

Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Feasibility (Completion rate of neoadjuvant treatment and surgery)

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

Major Pathological Response Rate

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

Radiographic Response

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

Full Information

NCT ID

NCT04973293

First Posted

July 13, 2021

Last Updated

April 20, 2023

Sponsor

Ruijin Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04973293

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2022 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ruijin Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Neoplasm Malignant

Keywords

Non-small cell lung cancer, Neoadjuvant therapy, Immunotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

sintilimab

Other Intervention Name(s)

IBI308, Xindili Dankang

Intervention Description

Sintilimab 200 mg, 4 cycles of treatment before surgery

Intervention Type

Drug

Intervention Name(s)

bevacizumab

Other Intervention Name(s)

Bei Fa Zhu Dankang Zhusheye

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Feasibility (Completion rate of neoadjuvant treatment and surgery)

Description

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

Title

Major Pathological Response Rate

Description

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

Time Frame

Two weeks after surgery

Title

Radiographic Response

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hecheng Li, MD, PhD

Phone

0086-021-64370045

lihecheng2000@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yuyan Zheng, MD

Phone

0086-15280093677

yuyanzheng@outlook.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hecheng Li, MD, PhD

Organizational Affiliation

Ruijin Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200025

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hecheng Li, MD,PHD

Phone

0086-021-64370045

lihecheng2000@hotmail.com

First Name & Middle Initial & Last Name & Degree

Yuyan Zheng, MD

Phone

0086-15280093677

yuyanzheng@outlook.com

First Name & Middle Initial & Last Name & Degree

Hecheng Li, MD,PHD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs