NCT04530227

Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage NSCLC

A Pilot Study of Camrelizumab With Chemotherapy in Adults With Medically Inoperable Early Stage Non-Small Cell Lung Cancer (NSCLC)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).

Detailed description

This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year. Explore objective is potential biomarker associated with efficacy.

Conditions

• Early Stage Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Biological: Camrelizumab	PD-1
DRUG	Pemetrexed	chemotherapy
DRUG	Nab-paclitaxel	chemotherapy

Timeline

• Start date: 2020-09-25
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2020-08-28
• Last updated: 2020-11-13

Locations

1 site across 1 country: China