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

NCT04945200 | Unknown

• 1 other identifier: 2020-1003
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

non-small cell lung cancer, neoadjuvant, biomarker

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

stage IB-IIIA NSCLC

You may qualify if:

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

You may not qualify if:

• Subjects are excluded if they are enrolled in any other interventional studies.
• Administration of chemotherapy, device therapy or any other cancer therapy in 4 weeks before the study drug administration.
• 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.
• Subjects with active concurrent malignancies are excluded i.e. cancers other than NSCLC.
• History of allergy to study drug components
• 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.
• Any other conditions that, in the Investigator's opinion, unfit to attend this study.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pingli Wang, M.D

CONTACT

+86 135 1680 8409; pingliwang@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 30, 2021
• Study Start: January 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 30, 2021

Record last verified: 2021-03

Locations

CN (1)