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Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer

Study acronym: Neo-Pre-IC
StatusActive, Not Recruiting
PhasePhase 2
Started2020-03-20
View on ClinicalTrials.gov ↗

Amendment history

2024-01-30
Study Status, Study Description v4
Study description+150 characters
[...] 17+12). In the first stage, the study will be concluded if ≤42 patients achieve MPR, indicating a negative outcome. Conver [...] r to detect an MPR rate of 35% under alternative hypotheses. MRD detectition： Using previously retained biomarkers from patients for MRD detection, exploring the relationship between MRD and patient DFS and OS.
2023-11-21
Study Status, Study Description v3
Study description+907 characters
Sample size calculation： The primary endpoint is the 2-year DFS rate，however, due to the extended observation time required for this endpoint, it is not suitable for promptly validating treatment response. MPR rate is employed to calculate the necessary sample size. Simon's optimal two-stage design [...]
2023-10-18
Recruiting→Active, Not Recruiting Study Identification, Study Status, Study Design, Eligibility, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2024-09→confirmed 2023-09-06
Start date2019-12-15→2020-03-20
Enrollment targetestimated 40→confirmed 30
Eligibility criteria+15 characters
[...] ition score: 0-2; Histologic examination confirmed that the potential resectable stage IIIA/IIIB non-small cell lung cancer (T4 or N2 according to the TNM s [...]
Study sitesdetails revised at 1 of 1 site
Study title+10 characters
Neoadjuvant Immunotherapy Plus Chemotherapy for UnresectablePotentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer
2023-06-06
Study Identification, Study Status v1
Primary completion date2021-12→2024-09
Completion date2022-12→2027-12
Study title+7 characters
Neoadjuvant Immunotherapy Plus Chemotherapy for ResectableUnresectable Stage IIIA/IIIB Non-Small Cell Lung Cancer
2020-03-27
Original filing
Cancer has always been one of the leading causes of death in the world, and China is facing more and more severe challenges from cancer. Among all the causes of cancer death, lung cancer (25.2%) ranks first, among which non-small cell lung cancer (NSCLC) accounts for about 80% to 85%, of which about 1 / 3 of the patients have been in the local advanced stage (IIIA stage / IIIB stage) at the time of initial diagnosis. For the patients with stage IIIA NSCLC who can be operated on, surgery is still the most effective way to treat them. Even so, NSCLC in stage I-III undergoing radical surgery is the most effective way 30-60% of the patients eventually had relapse or distant metastasis. Therefore, people began to explore a new treatment mode, preoperative neoadjuvant chemotherapy, to improve the survival rate of NSCLC 2. At present, the NCCN guidelines for the new adjuvant treatment of NSCLC mainly recommend platinum based dual drug chemotherapy. Immunotherapy combined with chemotherapy will be a potential new adjuvant therapy in the future, which can improve the resection rate of patients, reduce the recurrence rate after surgery, and have tolerable adverse reactions.
Trial Details
NCT Number NCT04326153
Lead Sponsor The First Hospital of Jilin University
Conditions IIIA Stage Non-small Cell Lung Cancer
Enrollment 30 participants
Start Date 2020-03-20
Primary Completion 2023-09-06 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2024-02-01