Spots Global Cancer Trial Database for A Study of Camrelizumab Plus Apatinib as Consolidation Therapy in Non-Small Cell Lung Cancer Patients Treated With Chemoradiotherapy

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Trial Identification

Brief Title: A Study of Camrelizumab Plus Apatinib as Consolidation Therapy in Non-Small Cell Lung Cancer Patients Treated With Chemoradiotherapy

Official Title: A Phase II, Open-Label, Multi-Centre Study of Camrelizumab Plus Apatinib As Consolidation Therapy in Patients With Locally Advanced, Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy

Study ID: NCT04749394

Conditions

Locally Advanced Non-Small Cell Lung Cancer

Interventions

Camrelizumab, PD-1 monoclonal antibody

Apatinib, VEGFR2 antibody

Study Description

Brief Summary: This is a phase II, open-Label, multi-centre study to determine the efficacy and safety of Camrelizumab plus apatinib in participants with unresectable Stage III Non-Small Cell Lung Cancer (NSCLC), who have not progressed following platinum-based concurrent chemoradiation therapy (cCRT) or sequential chemoradiation therapy (sCRT). This study will be conducted in China mainland.

Detailed Description: This trial will evaluate the efficacy and safety of camrelizumab plus apatinib in participants with unresectable stage III NSCLC who have not progressed following definitive, platinum-based cCRT or sCRT. The primary endpoint is progression free survival (PFS) in the intent-to-treat (ITT) population. The secondary endpoints are as follows: 1) Overall survival (OS); 2) 1, 2, 3-year OS rates; 3) PFS rates at 12-monthand 18-month; 4) Objective response rate (ORR), 5) Duration of response (DoR); 6) Time to death or distant metastasis (TTDM); 7) Adverse effects (AEs) and severe adverse effects (SAEs) ;8) Quality of life (QoL).Exploratory objective is to explore potential biomarkers associated with efficacy.