Status and phase
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About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
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 1.
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):
Women of childbearing age must undergo a serological pregnancy test within 7 days before the first dose with negative results and willing to use a medically approved and effective contraceptive method (e.g. intrauterine device, contraceptive pill or condom) during the study and within two months after the last dose. For male subjects whose partners are women of childbearing age, they should be sterilized surgically or agree to use effective contraceptive methods during the study and within two months after the last dose.
Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
62 participants in 1 patient group
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Central trial contact
Xiuyu Cai, MD
Data sourced from clinicaltrials.gov
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