NCT05244213

Neoadjuvant Immunotherapy in EGFR-mutant Localized NSCLC

Neoadjuvant Sintilimab Plus Chemotherapy in EGFR-mutant Stage II-IIIB NSCLC: A Single-arm, Open-label Prospective Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Phase II, single-arm, open-label single center study that assess clinical feasibility and safety of 3 cycles neoadjuvant Sintilimab plus chemotherapy in EGFR-mutant stage IIB-IIIB NSCLC (excluding N3) followed by optional adjuvant treatment upon investigators' decisions.

Detailed description

35 eligible patients will be enrolled and 3 cycles of Sintilimab 200mg + doublet platinum-based chemotherapy will be administered. Dynamic blood samples before, during or after neoadjuvant treatment will be obtained for exploratory analysis. Patients who showed inferior response to neoadjuvant treatment leading to unresectable disease will be scheduled for local radiation or other potential subsequent treatment regarding multidisciplinary discussion. After completion of local treatment (surgery or radiation), patients will be provided with optional adjuvant treatment including EGFR-TKI upon investigators' consideration. Patients will be followed with 5 years after surgery. The primary objective of the study is major pathological response (MPR) defined as no more than 10% residual tumor found in primary lung cancer.

Conditions

• Non-small Cell Lung Cancer
• EGFR Activating Mutation

Interventions

Type	Name	Description
BIOLOGICAL	Sintilimab	200mg Q3W
DRUG	Carboplatin	AUC 5, d1 every 3 weeks
DRUG	Nab paclitaxel	260 mg/m2, d1 every 3 weeks

Timeline

• Start date: 2022-06-04
• Primary completion: 2024-06-05
• Completion: 2025-12-01
• First posted: 2022-02-17
• Last updated: 2024-07-08

Locations

1 site across 1 country: China