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Report for Clinical Trial NCT04316351

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

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

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.

NCT04316351 IIIb/IV NSCLC With T790M Positive Mutations Failed to Osimertinib Therapy
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: Toripalimab + Pemetrexed + Anlotinib

Description: Toripalimab 240 mg iv d1 + anlotinib 12mg po d1-d14 + pemetrexed 500mg / m2 d1 Q3W for 4 cycles, followed by Toripalimab 240mg iv d1 + anlotinib 12mg po d1 + pemetrexed 500mg / m2 d1 Q3W for another 31 cycles (up to a total of 35 cycles). If there is no disease progression, patients will receive anlotinib po 12mg d1-d14 + pemetrexed 500mg / m2 d1, Q3W for maintenance therapy until PD per RECIST v1.1 or loss of clinical benefit.
Type: Drug
Group Labels: 1

Toripalimab + Pemetrexed + Anlotinib


Primary Outcomes

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 years

Secondary Outcomes

Description: assessed by IRC and researchers based on RECIST 1.1

Measure: Progression-free survival (PFS)

Time: two years

Description: assessed by IRC and researchers based on RECIST 1.1

Measure: Overall survival (OS)

Time: two years

Description: assessed by IRC and researchers based on RECIST 1.1

Measure: Disease Control Rate (DCR)

Time: two years

Description: assessed by IRC and researchers based on RECIST 1.1

Measure: Duration of disease response (DOR)

Time: two years

Description: 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 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 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: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 ---



HPO Nodes


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