Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer: Clinical Response and Biomarkers Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945200
• Other study ID #: 2020-1003
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2021
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Pingli Wang, M.D
• Phone: +86 135 1680 8409
• Email: pingliwang[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The primary object of this study is to determine tumor major pathological response (MPR) rate and pathologic complete response (pCR) rate in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy and molecular biomarkers related to the clinical response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1.Able to understand the nature of this trial and provide written informed consent. 2.18 years = age = 80 years 3.Histologically documented non-small cell lung cancer 4.NSCLC with resection option for potential cure.This may include clinical stage IB, II and IIIA. 5.Subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy according to disease evaluation. 6.Measurable disease by RECIST v1.1 7.Tumor tissue sample and/or alveolar lavage fluid must be available for biomarker evaluation before operation.

Exclusion Criteria:

1. Subjects are excluded if they are enrolled in any other interventional studies.

2. Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration.

3. Subjects are excluded if they have an active, known or suspected autoimmune disease requiring systemic treatment (e.g.corticosteroids or other immunosuppressive medications) in 2 years before the study drug administration. substitution therapy ( e.g. thyroxine, insulin) are permitted.

4. Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC.

5. History of allergy to study drug components

6. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results.

7. Any other conditions that, in the Investigator's opinion, unfit to attend this study.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	molecular biomarkers related to clinical response	molecular biomarkers related to tumor major pathological response (MPR) and pathologic complete response (pCR) in stage IB-IIIA non-small cell lung cancer who subjected to neoadjuvant immune checkpoint inhibitor combined with chemotherapy	change from baseline to postoperation, an average of 1 week