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

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT04945200
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-03
• Study First Submitted: 2021-06-17
• Study First Submitted QC: 2021-06-21
• Last Update Submitted: 2021-06-21
• Study First Posted: 2021-06-30
• Last Update Posted: 2021-06-30
• Primary Completion: 2023-06
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
molecular biomarkers related to clinical response	change from baseline to postoperation, an average of 1 week	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

Trial Locations

Locations (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China