Efficacy and Safety of NSCLC Patients With/Without Adjuvant Immunotherapy Who Have Achieved pCR After Neoadjuvant Immunotherapy

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Description

This is a prospective, observational, multicenter real-world study aiming to investigate the efficacy and safety of NSCLC patients with or without adjuvant immunotherapy who have achieved pathologic complete remission after neoadjuvant immunotherapy.

Study Overview

Start Date
February 1, 2024
Completion Date
December 1, 2027
Enrollment
100
Date Posted
February 6, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Xiangya Hospital, Central South University Affiliated
Changsha, Hunan 410008, China

Eligibility

Study Population
Patients diagnosed with resectable/potentially resectable non-small cell lung cancer (NSCLC) who have received immune checkpoint inhibitor neoadjuvant therapy and achieved pathological complete response (pCR).
Minimum Age (years)
18
Eligibility Criteria
Inclusion Criteria:

Histologically or cytologically confirmed resectable/potentially resectable NSCLC of stage IB-IIIB (AJCC 8th edition).
Completed neoadjuvant immunotherapy (3 cycles) and achieved pathological complete response (pCR) postoperatively.
With or without adjuvant immunotherapy postoperatively.
Underwent at least one effective imaging evaluation during the adjuvant treatment period.

Exclusion Criteria:

Incomplete clinical data for patients, such as missing treatment history, surgical specimen pathology results, etc.
Follow-up data less than 36 months.
Patients with multiple primary tumors.
History of malignancy other than NSCLC within the past 5 years.
Previous treatment with PD-1/PD-L1 inhibitors.
Excluded patients with positive EGFR/ALK driver gene mutations
Receipt of other investigational drugs during the observation period.

Study Contact Info

Study Contact Name
Juan Jiang, PhD
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
No
NCTid (if applicable)
NCT06243679