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
Overview
- Phase
- Phase 2
- Intervention
- Camrelizumab, PD-1 monoclonal antibody
- Conditions
- Locally Advanced Non-Small Cell Lung Cancer
- Sponsor
- Chinese Academy of Medical Sciences
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Progression-free Survival (PFS)
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Zhouguang Hui, M.D.
Chief physician, Director of VIP Department
Chinese Academy of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •Patients aged ≥18 years, male and female are not limited;
- •Patients with ECOG score of 0-1;
- •Life expectancy ≥12 weeks;
- •Patients must have histologically or cytologicallyproved NSCLC, and present with locally advanced, unresectable Stage III disease(according to 8th AJCC/UICC Classification);
- •Receipt of concurrent or sequential chemoradiation therapy which must have been completed within 42 days prior to first dose administration of the study; Consolidation chemotherapy is not permitted.
- •No progression following definitive, platinum-based, concurrent or sequential chemoradiation therapy;
- •Subject with prior anti-cancer treatment can only be enrolled when all toxicities of prior anti-cancer treatment has recovered to baseline or ≤ Grade 1, except for hearing loss, alopecia and fatigue. (according to National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] V5.0);
- •No prior exposure to any anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-VEGF treatments, as well as therapeutic anticancer vaccines;
- •Agreement to provide tumor histological specimens required for this study;
- •Adequate organ and marrow function required;
Exclusion Criteria
- •Mixed small cell lung cancer histology;
- •Disease progression after concurrent/sequential chemoradiotherapy;
- •Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of treatment;
- •Receipt of live attenuated vaccine within 28 days prior to the first dose of treatment;
- •Previous enrolment of another study and receiving any study drug within 28 days prior to the first dose of treatment;
- •Patients with ≥Grade 2 pneumonitis from the prior anti-cancerchemoradiation therapy;
- •Imaging (CT or MRI) shows the tumor invading large vessels or blurring the boundary with vessels;
- •History of organ transplant or allogeneic hematopoietic stem cell transplantation;
- •Patients with any active autoimmune disease or history of autoimmune disease;
- •Patients with innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection;
Arms & Interventions
Experimental Arm
Camrelizumab plus apatinib as consolidation therapy
Intervention: Camrelizumab, PD-1 monoclonal antibody
Experimental Arm
Camrelizumab plus apatinib as consolidation therapy
Intervention: Apatinib, VEGFR2 antibody
Outcomes
Primary Outcomes
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)
PFS is determined by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
Secondary Outcomes
- PFS at 18 months (PFS18)(up to maximum 18 months)
- OS at 12 months (OS12)(up to maximum 12 months)
- OS at 24 months (OS24)(up to maximum 24 months)
- TTDM(up to approximately 36 months)
- Number of participants with AEs, SAEs, Treatment-related Adverse Events (TRAEs).(From screening (Day -28) till final visit (up to a maximum of 24 months))
- Overall Survival (OS)(up to approximately 36 months)
- PFS at 12 months (PFS12)(up to maximum 12 months)
- OS at 36 months (OS36)(up to maximum 36 months)
- Objective response rate (ORR)(up to approximately 24 months)
- Duration of Response (DoR)(up to approximately 24 months)