NCT04326153

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

A Single-center Phase 2 Study of Neoadjuvant Immunotherapy Plus Chemotherapy for Potentially Resectable Stage IIIA/IIIB Non-Small Cell Lung Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The First Hospital of Jilin University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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 is utilized. The addition of sintilimab to chemotherapy is assumed to elevate the MPR rate from 8.9% to 35%. The sample size should be 29(17+12). In the first stage, the study will be concluded if ≤2 patients achieve MPR, indicating a negative outcome. Conversely, if more than 4 patients achieve MPR, the study will proceed by enrolling an additional 12 patients. Considering the sample size calculation results and sufficient funding, the final enrollment is 30. The type 1 error rate is 0.05. The outlined protocol yield an 95% statistical power 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.

Conditions

• IIIA Stage Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sintilimab Injection	Preoperative: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of two cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total Postoperative: Patients began to receive postoperative adjuvant treatment within 21-60 days after the operation. Specific medication plan: Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of 8 cycles. Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total. Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total.

Timeline

• Start date: 2020-03-20
• Primary completion: 2023-09-06
• Completion: 2027-12-01
• First posted: 2020-03-30
• Last updated: 2024-02-01

Locations

1 site across 1 country: China