SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03513666

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment:a Multi-center, Single Arm Phase II Study

JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment:a multi-center, single arm phase II study

NCT03513666 NSCLC

1 Interventions

Name: Drug intervention

Description: anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin

Type: Combination Product

treatment arm


Primary Outcomes

Description: The primary endpoint is the antitumor activities in this study

Measure: Objective response rate (ORR)

Time: 12 weeks

Secondary Outcomes

Description: Progression free survival (PFS)

Measure: PFS

Time: 18 months

Description: Overall survival (OS)

Measure: OS

Time: 18 months

Description: Duration of response (DOR)

Measure: DOR

Time: 18 months

Purpose: Treatment

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; NSCLC null --- L858R ---

Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; NSCLC null --- L858R --- --- T790M --- --- L858R ---


2 T790M

Toripalimab Combined With Pemetrexed Plus Carboplatin for Treatment of Recurrent or Advanced Non-small-cell Lung Cancer With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment:a Multi-center, Single Arm Phase II Study. --- T790M ---

A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment:a multi-center, single arm phase II study Objective response rate (ORR). --- T790M ---

A Study of Toripalimab+ Pemetrexed Plus Carboplatin in Patients With EGFR-mutation Positive and T790M Negative After Progression on EGFR-TKI Treatment JS001 combined with pemetrexed plus carboplatin for treatment of recurrent or advanced non-small-cell lung cancer with EGFR-mutation positive and T790M negative after progression on EGFR-TKI treatment:a multi-center, single arm phase II study Objective response rate (ORR). --- T790M --- --- T790M ---

Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; NSCLC null --- L858R --- --- T790M ---

Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; Inclusion Criteria: Only the patients meeting all the following criteria can be eligible to participate in the trial: - Histologically and/or cytologically confirmed advanced or recurrent non-small cell lung cancer with EGFR sensitive mutation (exon 19 deletion, exon 21 L858R), and meeting the following conditions at the same time: - Previous first-line EGFR-TKI monotherapy with clinical benefit, followed by progression of disease; - No exon 20 T790M mutation after failure of EGFR-TKI therapy; - At least one measurable lesion (in accordance with RECIST 1.1); Exclusion Criteria: Patients who fulfill any of the following criteria must be excluded from the study: - Histologically or cytopathologically confirmed combined with small cell lung cancer component or squamous cell carcinoma component >10%; - Combined with other driver gene mutation with known drug therapy, including but not limited to ALK rearrangement, ROS1 mutation, BRAF600E mutation etc.; - Previous systemic chemotherapy for advanced NSCLC; - EGFR-TKI therapy within two weeks prior to enrollment; NSCLC null --- L858R --- --- T790M --- --- L858R --- --- T790M ---



HPO Nodes