Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05284539
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2022-01-22
Brief Title:
Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFRALKROS1 Mutant Lung Cancer
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
Efficacy of Platinum-based Chemotherapy With or Without Immune Checkpoint Inhibitors in Patients With EGFRALKROS1 Sensitive Mutated NSCLC Who Progressed From Previous Tyrosine Kinase Inhibitors TKI Therapy
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Awesome
Brief Summary:
The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFRALKROS1 Positive NSCLC who Failed from First-Line Standard Treatment
Detailed Description:
The investigators want to evaluate the Efficacy and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFRALKROS1 Positive NSCLC who Failed from First-Line Standard Treatment
This study will be divided into three cohorts Cohort A for EGFR mutation NSCLC Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included
Cohort B for ALK fusion NSCLC Patient with NGS identified ALK fusion NSCLC who failed from first line AlectinibLorlatinibCeritinibEnsartinibBrigatinib will be included All the patients will be divided two group3ALK and 3ALK with retention of 5ALK
Cohort C for ROS1 fusion NSCLC Patient with NGS identified ROS1 fusion NSCLC who failed from first line CrizotinibEntrectinibEnsartinibBrigatinib will be included
The investigators will collect the safety and efficacy data for all the patients
The tissue and blood samples will be collected under the permission of the participate
Single cell sequencing DSP RNA-seq and IHC will be performed to evaluate the TME
This study will be divided into three cohorts Cohort A for EGFR mutation NSCLC Patient with NGS identified EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included
Cohort B for ALK fusion NSCLC Patient with NGS identified ALK fusion NSCLC who failed from first line AlectinibLorlatinibCeritinibEnsartinibBrigatinib will be included All the patients will be divided two group3ALK and 3ALK with retention of 5ALK
Cohort C for ROS1 fusion NSCLC Patient with NGS identified ROS1 fusion NSCLC who failed from first line CrizotinibEntrectinibEnsartinibBrigatinib will be included
The investigators will collect the safety and efficacy data for all the patients
The tissue and blood samples will be collected under the permission of the participate
Single cell sequencing DSP RNA-seq and IHC will be performed to evaluate the TME
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None