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

Sponsor
Chinese Academy of Medical Sciences
Study ID
NCT04749394
Phase
PHASE2
Status
Unknown

Conditions

  • Locally Advanced Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab, PD-1 monoclonal antibody — DRUG
    Camrelizumab 200mg IV, Q3W, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.
  • Apatinib, VEGFR2 antibody — DRUG
    Apatinib 250mg PO, QD, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.

Study Details

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.

Key Dates

Start date
Mar 17, 2021
Status verified
Aug 2022
Primary completion
Jan 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental Arm
    Camrelizumab plus apatinib as consolidation therapy

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: From the first date of treatment until the date of objective disease progression or death (up to maximum 24 months) ]

Central Contacts