Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06196814
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2023-12-25
Brief Title:
AK112 Plus Platinum-based Chemotherapy for EGFRALKROS1 Positve NSCLC
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
Efficay and Satety of PD-1VEGR Bispecific Antibodies AK112 Plus Platinum-based Chemotherapy for EGFRALKROS1 Positve NSCLC A Multiple Centers Multiple Cohorts Dose Escalation Phase II Apple Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
Apple
Brief Summary:
The investigators want to evaluated the Efficay and Satety of PD-1VEGR bispecific antibodies AK112 plus Platinum-based Chemotherapy for EGFRALKROS1 Positve NSCLC who Failed from First-Line Standard Treatment
Detailed Description:
The investigators want to evaluated the Efficay and Satety of PD-1VEGR bispecific antibodies AK112 plus Platinum-based Chemotherapy for EGFRALKROS1 Positve NSCLC who Failed from First-Line Standard Treatment
This study will be devided into three cohorts Cohort A for EGFR mutation NSCLC Patient with NGS idenfied EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included The 33 stud will conducted for dose escalation for AK112 from 20mg to 30mg and than the fix dose will be set up for cohort A B and C
Cohort B for ALK fusion NSCLC Patient with NGS idenfied ALK fusion NSCLC who failed from first line Alectinib will be included All the patients will be devided two group3ALK and 3ALK with reteintion of 5ALK All the patients will be treated with PD-1VEGR bispecific antibodies AK112 plus Platinum-based Chemotherapy
Cohort C for ROS1 fusion NSCLC Patient with NGS idenfied ROS1 fusion NSCLC who failed from first line crizotinib or Entrectinib will be included All the patients will be treated with PD-1VEGR bispecific antibodies AK112 plus Platinum-based Chemotherapy
The investigators will collect the satety and efficacy data for all the patients
This study will be devided into three cohorts Cohort A for EGFR mutation NSCLC Patient with NGS idenfied EGFR sensitive mutation NSCLC who failed from first line Osimertinib will be included The 33 stud will conducted for dose escalation for AK112 from 20mg to 30mg and than the fix dose will be set up for cohort A B and C
Cohort B for ALK fusion NSCLC Patient with NGS idenfied ALK fusion NSCLC who failed from first line Alectinib will be included All the patients will be devided two group3ALK and 3ALK with reteintion of 5ALK All the patients will be treated with PD-1VEGR bispecific antibodies AK112 plus Platinum-based Chemotherapy
Cohort C for ROS1 fusion NSCLC Patient with NGS idenfied ROS1 fusion NSCLC who failed from first line crizotinib or Entrectinib will be included All the patients will be treated with PD-1VEGR bispecific antibodies AK112 plus Platinum-based Chemotherapy
The investigators will collect the satety and efficacy data for all the patients
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