A Single-Arm Phase II Trial of Camrelizumab Plus Apatinib for Advanced Non-Squamous NSCLC Previously Treated With First-Line Immunotherapy
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab
- Conditions
- Advanced Non Squamous NSCLC
- Sponsor
- Junling Li
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS)
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of this study is to assess the efficacy and safety of Camrelizumab plus Apatinib in the treatment of advanced non-squamous NSCLC previously treated with first-line immunotherapy
Detailed Description
This trial will evaluate the safety and efficacy of Camrelizumab plus Apatinib in participants with advanced non-squamous NSCLC previously treated with first-line immunotherapy. The primary objective of this pilot study is to determine the Camrelizumab plus Apatinib improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) duration of response(DoR), 3) overall survival(OS), 4) disease control rate (DCR); the safety and quality of life assessment Explore objective is potential biomarker associated with efficacy.
Investigators
Junling Li
Prof. Junling Li, Chief Physician, Medical Doctor, PhD Tutor, Internal Medicine-Oncology, Chinese Academy of Medical Sciences Cancer Hospital
Peking Union Medical College
Eligibility Criteria
Inclusion Criteria
- •Provision of signed (infomed consent form, ICF).
- •The best response of first-line immunotherapy was SD or above, and PFS was at least 3 months.
- •Male and female aged ≥18 years and ≤75 years.
- •Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy.
- •Patients who are unwilling to receive chemotherapy after disease recurrence or progression during/after first-line treatment including PD-(L)1 combined with chemotherapy, and PD-(L)1 monotherapy for advanced or metastatic disease.
- •Measurable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Subjects are eligible if CNS metastases are asymptomatic or treated.
- •Life expectancy ≥12 weeks.
- •Fertile female must agree to use adequate contraception within 24 weeks from the beginning of the first dose of study medication to the last dose.
Exclusion Criteria
- •Prior treatment with anti-tumor virus, or prior T cell co-stimulation factors,including anti-Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA-4) antibody or other T cell-targeted drugs.
- •Subjects who had discontinued prior treatment due to immune-related adverse events (irAEs) or who are not suitable for PD-(L)1 treatment assessed by the investigator.
- •Subjects with histologically or cytologically-documented squamous cell NSCLC.
- •Prior treatments with anti-angiogenic agents.
- •Subjects with activated EGFR gene mutation or ALK fusion mutation.
- •Untreated or active central nervous system metastases (such as brain or meningeal metastases). Subjects are eligible if CNS metastases are asymptomatic or treated and subjects are off corticosteroids for at least 2 weeks prior to first dose of study therapy.
- •Radiotherapy for the chest and whole brain should be completed within 4 weeks before the first dose of study drug (palliative radiotherapy for bone lesions should be completed before the first dose of study drugs).
- •History of active or recent history of known or suspected autoimmune disease.
- •History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or evidence of active pneumonitis with clinical symptoms.
- •History of active tuberculosis regardless of prior treatment.
Arms & Interventions
Camrelizumab plus Apatinib
Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po
Intervention: Camrelizumab
Camrelizumab plus Apatinib
Camrelizumab, 200mg, q3w, iv and Apatinib, 250mg, qd, po
Intervention: Apatinib
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: up to 1 year
PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Secondary Outcomes
- Duration of Response(up to 1 year)
- Overall Survival (OS)(up to 2 years)
- Adverse Events (AEs) and Serious Adverse Events(SAEs)(up to 1 year)
- QLQ-LC13(up to 1 years)
- Objective response rate (ORR)(up to 1 year)
- Disease Control Rate (DCR)(up to 1 year)
- EORTCQLQ-C30(up to 1 years)