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Trial Title:
Efficacy and Safety of NSCLC Patients With/Without Adjuvant Immunotherapy Who Have Achieved pCR After Neoadjuvant Immunotherapy
NCT ID:
NCT06243679
Condition:
Resectable/Potentially Resectable NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Immunomodulating Agents
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Immunotherapy
Description:
Monotherapy with PD-1 inhibitors, up to 1 year.
Arm group label:
Adjuvant immunotherapy
Summary:
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.
Criteria for eligibility:
Study pop:
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).
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Histologically or cytologically confirmed resectable/potentially resectable NSCLC of
stage IB-IIIB (AJCC 8th edition).
2. Completed neoadjuvant immunotherapy (3 cycles) and achieved pathological complete
response (pCR) postoperatively.
3. With or without adjuvant immunotherapy postoperatively.
4. Underwent at least one effective imaging evaluation during the adjuvant treatment
period.
Exclusion Criteria:
1. Incomplete clinical data for patients, such as missing treatment history, surgical
specimen pathology results, etc.
2. Follow-up data less than 36 months.
3. Patients with multiple primary tumors.
4. History of malignancy other than NSCLC within the past 5 years.
5. Previous treatment with PD-1/PD-L1 inhibitors.
6. Excluded patients with positive EGFR/ALK driver gene mutations
7. Receipt of other investigational drugs during the observation period.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Xiangya Hospital, Central South University Affiliated
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Recruiting
Contact:
Last name:
Juan Jiang
Start date:
February 1, 2024
Completion date:
December 1, 2027
Lead sponsor:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Source:
Xiangya Hospital of Central South University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06243679
