NCT04506242

Camrelizumab With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer

Efficacy and Safety of Camrelizumab (SHR-1210) With Apatinib as Neoadjuvant Therapy for Participants With Resectable Non-Small Cell Lung Cancer: a Single-Arm, Phase II Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial will evaluate the safety and efficacy of Camrelizumab (SHR-1210) in combination with apatinib neoadjuvant therapy before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with resectable stage IIA-IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC).

Detailed description

This trial will evaluate the safety and efficacy of camrelizumab in combination with apatinib neoadjuvant chemotherapy (NAC) before surgery \[neoadjuvant phase\], followed by camrelizumab alone after surgery \[adjuvant phase\] in participants with resectable stage II, IIIA, and resectable IIIB (T3N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant camrelizumab in combination with apatinib, followed by surgery and adjuvant camrelizumab will improve: 1)MPR assessed by investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) ; 2) event free survival (EFS) and 3) overall survival (DFS).

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	SHR-1210	PD-1
DRUG	Apatinib	VEGFR2

Timeline

• Start date: 2020-09-15
• Primary completion: 2021-12-30
• Completion: 2025-12-30
• First posted: 2020-08-10
• Last updated: 2020-09-09