NCT04459078

Clinical Study of Camrelizumab Combined With APatinib and Albumin Paclitacxel in Patients With Advanced Lung Adenocarcinoma

A Prospective Single-arm Phase II Clinical Study to Evaluate the Efficacy of Camrelizumab in Combined With APatinib and Albumin Paclitacxel in Advanced Untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Hunan Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single arm, open label, national multicenter study, to explore the efficacy and safety of the combination of Camrelizumab, apatinib and albumin paclitaxel in advanced untreated EGFR Wild Type and ALK-negative Lung Adenocarcinoma. The study does not consider PD-L1 expression, but tumor samples need to be explored by PD-L1 detection and other exploratory analysis.

Detailed description

Primary outcome: 1\. progression free survival (PFS) evaluated according to RECIST1.1. Secondary outcome: 1. Objective Response Rate (ORR), Overall Survival (OS), Disease Control Rate (DCR), Duration of Response (DOR) evaluated according to RECIST1.1, and Quality of Life(QOL). 2. The overall incidence of adverse events (AE); the incidence of grade 3 or above AE; the incidence of serious adverse events (SAE); the incidence of AE leading to the termination of the trial drug; the incidence of AE leading to the suspension of the trial drug. 3. Exploratory analysis of potential biomarkers related to efficacy. The characteristics of tumor tissue PD-L1expression, panel-captured next generation sequencing(NGS), RNA-seq, T-Cell Repertoire (TCR), multiple immunofluorescence and other biomarkers, and the correlation analysis of biomarkers with efficacy and safety.

Conditions

• Adenocarcinoma of the Lung

Interventions

Type	Name	Description
DRUG	Camrelizumab	Intravenous administration of (200mg/3weeks)
DRUG	Albumin Paclitacxel	intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles)
DRUG	Apatinib	Patients will be given oral of Apatinib (250mg Qd po for 5 days, take rest for 2 days every week)

Timeline

• Start date: 2020-08-26
• Primary completion: 2023-05-15
• Completion: 2023-07-15
• First posted: 2020-07-07
• Last updated: 2022-12-02

Locations

3 sites across 1 country: China