This is an open-label, single-arm, multi-center, phase II exploratory study that evaluates the efficacy and safety of Toripalimab injection (JS001) combined with Pemetrexed and Anlotinib as a second-line treatment for patients with T790M positive Non-Small Cell Lung Cancer (IIIb / IV ) after Osimertinib resistance.
Name: Toripalimab + Pemetrexed + Anlotinib
Description: Defined as percentage of participants achieving complete response (CR) and partial response (PR) assessed by the Independent Review Committee (IRC) according to the RECIST 1.1
Measure: Overall response rate (ORR) Time: two yearsDescription: assessed by IRC and researchers based on RECIST 1.1
Measure: Progression-free survival (PFS) Time: two yearsDescription: assessed by IRC and researchers based on RECIST 1.1
Measure: Overall survival (OS) Time: two yearsDescription: assessed by IRC and researchers based on RECIST 1.1
Measure: Disease Control Rate (DCR) Time: two yearsDescription: assessed by IRC and researchers based on RECIST 1.1
Measure: Duration of disease response (DOR) Time: two yearsDescription: overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.
Measure: overall incidence of adverse events (AE) Time: two yearsAllocation: N/A
Single Group Assignment
There is one SNP
Efficacy and Safety of Toripalimab (JS001) Combined With Pemetrexed and Anlotinib for Patients With T790M Positive Non-Small Cell Lung Cancer After Osimertinib Resistance:a Phase II,Muti-center, Single Arm Study. --- T790M ---
Efficacy and Safety of Toripalimab (JS001) Combined With Pemetrexed and Anlotinib for Patients With T790M Positive Non-Small Cell Lung Cancer After Osimertinib Resistance This is an open-label, single-arm, multi-center, phase II exploratory study that evaluates the efficacy and safety of Toripalimab injection (JS001) combined with Pemetrexed and Anlotinib as a second-line treatment for patients with T790M positive Non-Small Cell Lung Cancer (IIIb / IV ) after Osimertinib resistance. --- T790M ---
Efficacy and Safety of Toripalimab (JS001) Combined With Pemetrexed and Anlotinib for Patients With T790M Positive Non-Small Cell Lung Cancer After Osimertinib Resistance This is an open-label, single-arm, multi-center, phase II exploratory study that evaluates the efficacy and safety of Toripalimab injection (JS001) combined with Pemetrexed and Anlotinib as a second-line treatment for patients with T790M positive Non-Small Cell Lung Cancer (IIIb / IV ) after Osimertinib resistance. --- T790M --- --- T790M ---
overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.. Inclusion Criteria: 1. Fully understand this study and voluntarily sign the informed consent form (ICF); 2. Histologically and/or cytologically confirmed Stage IIIb / IV NSCLC (according to the seventh edition of AJCC); patients with T790M-positive mutations who were resistant to Osimertinib treatment; 3. --- T790M ---
Inclusion Criteria: 1. Fully understand this study and voluntarily sign the informed consent form (ICF); 2. Histologically and/or cytologically confirmed Stage IIIb / IV NSCLC (according to the seventh edition of AJCC); patients with T790M-positive mutations who were resistant to Osimertinib treatment; 3. --- T790M ---
IIIb/IV NSCLC With T790M Positive Mutations Failed to Osimertinib Therapy Carcinoma, Non-Small-Cell Lung null --- T790M ---