Efficacy and Safety of Camrelizumab Combined With Nb-Paclitaxel in Patients With Recurrent/Metastatic Non-small-cell Lung Cancer After the Failure of Platinum-based Therapy

Sun Yat-sen University3 sites in 1 country62 target enrollmentJuly 30, 2019

ConditionsNon-Small Cell Lung Cancer

InterventionsCamrelizumab nb-Paclitaxel

DrugsCamrelizumab nb-Paclitaxel

Overview

Phase: Phase 2
Intervention: Camrelizumab
Conditions: Non-Small Cell Lung Cancer
Sponsor: Sun Yat-sen University
Enrollment: 62
Locations: 3
Primary Endpoint: Objective Response Rate (ORR)
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to explore the efficacy and safety of Camrelizumab in combination with nb-Paclitaxel in treating patients with recurrent/metastatic non-small-cell lung cancer.

Detailed Description

Camrelizumab is a humanized monoclonal antibody against Programmed death 1(PD-1). Albumin-bound paclitaxel is a new nano-paclitaxel drug coated with human albumin. Patients with recurrent/metastatic non-small-cell lung cancer after the failure of platinum-based therapy will received Camrelizumab 200mg((3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks. The efficacy and safety will be observed.

Registry

clinicaltrials.gov

Start Date

July 30, 2019

End Date

September 30, 2022

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Xiuyu Cai

Xiuyu Cai，Principal investigator

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Male and Female ≥ 18 years of age
•Subjects enrolled must have histologically-confirmed or cytologically confirmed diagnosis of stage ⅢB,Ⅳnon-small cell lung cancer（NSCLC）,at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST)
•Disease progression experienced during or after one prior platinum containing doublet chemotherapy（excluding taxane chemotherapy）
•Subjects must have had no more than one prior systemic chemotherapeutic regimen Note: a. Replacement of platinum drugs for toxicity is considered as a systemic chemotherapeutic regimen; b.Subjects with recurrent disease \> 6 months after Postoperative adjuvant platinum based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen given to treat the recurrence, are eligible.
•Life expectancy ≥ 12 weeks.
•ECOG performance status of 0 or
•The main organ's function is normal and it should meet the following criteria:
•Blood routine examination should be complied with (No blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days):
•ANC ≥ 1.5×109/L；
•PLT ≥ 100×109/L；

Exclusion Criteria

•Subjects have a history of any active autoimmune disease or autoimmune disease including but not limited to the following: autoimmune hepatitis,interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism which can be included after hormone replacement therapy; Subjects with childhood asthma have been completely alleviated and without any intervention or vitiligo in adulthood can be included. Subjects who need medical intervention with bronchodilators can not be included.
•Participated in other clinical trials, or finish other clinical trials within 4 weeks.
•Known history of hypersensitivity to any components of the Camrelizumab formulation，or other monoclonal antibody.
•Known history of hypersensitivity to paclitaxel or albumin human .
•Peripheral blood neutrophils \<1500/mm3
•Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
•Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least two months prior to the first dose of trial treatment and any Neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 14 days prior to trial treatment.
•Clinically significant cardiovascular diseases, including but not limited to congestive heart failure (New York heart association (NYHA) class \> 2), unstable or severe angina, severe acute myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia which need medical intervention.
•Subjects with congenital or acquired immunodeficiency such as HIV infection, active hepatitis B (HBV DNA ≥ 2000 IU/ml), hepatitis C (hepatitis C antibody is positive).
•Subjects with other factors that might lead to the termination of the study, such as serious diseases (including mental illness) requiring combined treatment, severe laboratory abnormality, and family or social factors，which will affect the safety of the subjects, or the collection of data and samples. in the opinion of the treating Investigator.

Arms & Interventions

Camrelizumab +nb-Paclitaxel

Participants receive Camrelizumab 200mg(3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks until disease progression or unacceptable toxicity

Intervention: Camrelizumab

Camrelizumab +nb-Paclitaxel

Participants receive Camrelizumab 200mg(3mg/kg for underweight patients) iv and nb-Paclitaxel 260mg/m2 iv every 3 weeks until disease progression or unacceptable toxicity

Intervention: nb-Paclitaxel

Outcomes

Primary Outcomes

Objective Response Rate (ORR)

Time Frame: Up to approximately 12 months

ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

Secondary Outcomes

Duration of Response (DCR)(Up to approximately 24 months)
Progression-free Survival (PFS)(Time Frame: Up to approximately 24 months)
Duration of Response (DOR)(Up to approximately 24 months)
12-month PFS rate(From date of enrollment up to 12 months)
Overall survival (OS)(Up to approximately 24 months)
Incidence of Adverse Events (AEs) in the treatment of Camrelizumab in combination with nb-Paclitaxel(Up to approximately 24 months)