NCT04945200UnknownNot Applicable
Neoadjuvant Immune Checkpoint Inhibitor Combined With Chemotherapy in Non-small Cell Lung Cancer: Clinical Response and Biomarkers Analysis
Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country50 target enrollmentStarted: January 1, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- molecular biomarkers related to clinical response
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
Primary Outcomes
molecular biomarkers related to clinical response
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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