NCT06485557

A Prospective Cohort Study of Neoadjuvant Chemotherapy Plus Sintillumab in the Treatment of Resectable NSCLC

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study uses a prospective cohort design.Subjects are randomly divided into three groups (A, B, C) before surgery. Group A gets 3 cycles of sintilimab + chemo, Group B gets 2 cycles + 1 cycle, and Group C gets 1 cycle + 2 cycles. Non-squamous NSCLC subjects receive pemetrexed/albumin paclitaxel + platinum, while squamous NSCLC subjects get albumin paclitaxel + platinum.

Detailed description

This study adopts a prospective cohort study design.The subjects will be randomly divided into three groups according to the ratio of 1:1:1 prior to surgery: group A, group B and group C. The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy, group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab, and group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab. Non-squamous NSCLC subjects will receive pemetrexed/albumin paclitaxel and platinum (cisplatin/carboplatin), and squamous NSCLC subjects will receive albumin paclitaxel and platinum (cisplatin / carboplatin).

Conditions

• Resectable Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	sintilimab plus platinum-based chemotherapy	The subjects in group A will receive 3 cycles of sintilimab plus platinum-based chemotherapy
DRUG	sintilimab plus platinum-based chemotherapy	The subjects in group B will receive 2 cycles of sintilimab plus platinum-based chemotherapy plus 1 cycle of sintilimab
DRUG	sintilimab plus platinum-based chemotherapy	The subjects in group C will receive 1 cycle of sintilimab plus platinum-based chemotherapy plus 2 cycles of sintilimab.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-12-31
• Completion: 2026-08-01
• First posted: 2024-07-03
• Last updated: 2024-07-03