The primary hypothesis is that camrelizumab in combination with pemetrexed/ carboplatin will present a better efficacy for treatment of first line metastatic non-squamous non-small cell lung cancer and minimize the risk of toxicity
This is a prospective, open-label, phase Ⅱ studyto evaluate the efficacy and safetyof camrelizumab combined with pemetrexed/ carboplatin in participants with brain metastases ofnon-squamous non-small cell lung cancer.Paticipant was confirmed without EGFR activating mutation or ALK fusion, and received no prior systemic therapy.Patients would receive camrelizumab in combination with pemetrexed/ carboplatin for 4 cycles,followed by camrelizumab and pemetrexed as maitenance treatment until progression, camrelizumab will be administered no more than 24 months. PD-L1 expression assessed with 22C3 pharmDx assay will be used as a stratification factor.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment,Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment,Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment,Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
Li-Kun Chen
Guangzhou, Guangzhou, China
Intracranial Objective Response Rate (iORR)
iORR 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) of intracranial lesion according to modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Time frame: 1 year
Intracranial Progression-Free Survival(iPFS)
Intracranial Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression in intracranial lesions according to modified RECIST 1.1 or death from any cause
Time frame: 3.5year
Objective Response Rate (ORR)
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
Time frame: 3.5year
Progression-free Survival (PFS)
Progression-free survival is defined as the duration from date of enrollment to the first occurrence of progression of overall disease or death from any cause
Time frame: 3.5year
Incidence of Adverse Events (AEs)
Incidence of Adverse Events (AEs) in the treatment of Camrelizumab combined with pemetrexed / carboplatin for patients with brain metastasis according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Time frame: 3.5year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.