NCT05005468

A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA NSCLC.

A Phase II Trial of Camrelizumab Combined With Famitinib for Adjuvant Treatment of Stage II-IIIA Non-small Cell Lung Cancer With High-risk for Relapse and no Driver Gene Mutation.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, open-label, multi-cohort study, aiming to investigate safety and efficacy of Camrelizumab combined with famitinib for adjuvant treatment of stage II-IIIA non-small cell lung cancer with high-risk for relapse and no driver gene mutation.

Detailed description

Immunotherapy has shown good efficacy in advanced NSCLC. The IMpower010 study has found that immune adjuvant therapy after postoperative chemotherapy can significantly prolong disease-free survival. A number of basic and clinical studies have found that anti-vascular drugs can improve the tumor immune microenvironment, and the combination of anti-vascular and immunotherapy may further improve the efficacy. In this study, postoperative NSCLC with a high risk of recurrence was screened out through ctDNA detection, and received Camrelizumab combined with famitinib or observation to observe the efficacy and safety.

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab is given on the first day of each cycle, intravenous drip.
DRUG	Famitinib	Famitinib is administered orally, once a day.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2021-08-13
• Last updated: 2021-08-13

Locations

1 site across 1 country: China