Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777084
Status:
RECRUITING
Last Update Posted:
2023-12-27
First Post:
2021-02-27
Brief Title:
The Efficacy and Safety of the Bispecific Anti-PD-1PD-L1 Antibody IBI318 Combined With Lenvatinib in NSCLC
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
A Prospective Multi-cohort Clinical Research of Efficacy and Safety of Bispecific Anti-PD-1 PD-L1 Antibody IBI318 Combined With Lenvatinib in the Treatment of Advanced NSCLC
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The study is a prospective multi-cohort clinical study Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1PD-L1 inhibitor therapy Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation ALK fusion after EGFR-TKI ALK-TKI treatment resistance Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR ALK and ROS1 wild-type After being screened to meet the inclusion criteria they will receive IBI318 combined with lenvatinib until the disease progresses death toxicity is intolerable informed consent is withdrawn new anti-tumor therapy is started or the treatment is terminated for other reasons specified in the plan
Detailed Description:
The study is a prospective multi-cohort clinical study Cohort A is evaluating the efficacy and safety of IBI318 in combined with lenvatinib in advanced NSCLC patients who had failed first-line PD-1PD-L1 inhibitor therapy Cohort B is the efficacy and safety of advanced NSCLC with EGFR-sensitive mutation ALK fusion after EGFR-TKI ALK-TKI treatment resistance Cohort C is the efficacy and safety of first-line treatment of advanced NSCLC with negative PD-L1 expression and EGFR ALK and ROS1 wild-type
After being screened to meet the inclusion criteria they will receive IBI318 combined with lenvatinib until the disease progresses death toxicity is intolerable informed consent is withdrawn new anti-tumor therapy is started or the treatment is terminated for other reasons specified in the plan During the treatment RECIST v11 was used for clinical tumor imaging evaluation once every 6 weeks after 24 weeks of medication evaluation can be done every 8 weeks
Subjects receiving IBI318 combined with lenvatinib have the first evidence of imaging PD according to RECIST v11 If the subject is clinically stable there is no evidence of rapid imaging progress and the investigator assesses that it can continue from the study If the patient is benefited from the drug the subject can continue the current study treatment and the imaging evaluation must be repeated at least 6 weeks 7 days later for confirmation If PD is confirmed by re-assessment the subject should stop the study treatment if PD is not confirmed the study treatment will continue and the assessment will be carried out at the time point of the imaging examination plan specified in the plan until the PD is confirmed by imaging
After being screened to meet the inclusion criteria they will receive IBI318 combined with lenvatinib until the disease progresses death toxicity is intolerable informed consent is withdrawn new anti-tumor therapy is started or the treatment is terminated for other reasons specified in the plan During the treatment RECIST v11 was used for clinical tumor imaging evaluation once every 6 weeks after 24 weeks of medication evaluation can be done every 8 weeks
Subjects receiving IBI318 combined with lenvatinib have the first evidence of imaging PD according to RECIST v11 If the subject is clinically stable there is no evidence of rapid imaging progress and the investigator assesses that it can continue from the study If the patient is benefited from the drug the subject can continue the current study treatment and the imaging evaluation must be repeated at least 6 weeks 7 days later for confirmation If PD is confirmed by re-assessment the subject should stop the study treatment if PD is not confirmed the study treatment will continue and the assessment will be carried out at the time point of the imaging examination plan specified in the plan until the PD is confirmed by imaging
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