Ignite Creation Date:
2024-07-17 @ 10:55 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479759
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
LM-108 Antibody Combination With Sintilimab for Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Sponsor:
Shanghai Pulmonary Hospital Shanghai China
Organization:
Shanghai Pulmonary Hospital Shanghai China
Study Overview
Official Title:
A Multicenter Clinical Study of LM-108 Antibody in Combination With Sintilimab for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
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:
ACCLAIM
Brief Summary:
The goal of this clinical trial is to investigate the efficacy safety and tolerability of LM-108 antibody in combination with sintilimab for patients with locally advanced or metastatic Non-Small Cell Lung Cancer patients
Detailed Description:
This study is an open-label multi-cohort multi-center clinical trial evaluating the efficacy safety and tolerability of LM-108 monoclonal antibody combined with sintilimab in treatment-naïve or previously treated subjects with locally advanced or metastatic non-small cell lung cancer NSCLC There are two cohorts in the study1Cohort 1 NSCLC patients who developed secondary resistance after being sensitive to prior treatment with PD-1 inhibitors monotherapy or in combination with another systemic therapy for 6 months or more are eligible for this study2Cohort 2 Patients with locally advanced or metastatic NSCLC who have not received prior systemic treatment are eligible for this study
Subjects in Cohort 1 will receive LM-108 monoclonal antibody combined with sintilimab Subjects in Cohort 2 will receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles LM-108 monoclonal antibody combined with sintilimab will be maintained and the choice of chemotherapy regimen and the duration of use will be determined by the investigator Treatment will continue until disease progression unacceptable toxicity initiation of a new anti-tumor therapy withdrawal of informed consent loss to follow-up death or other investigator-determined reasons for discontinuation whichever occurs first with a maximum treatment duration of 24 months The primary study endpoint is the objective response rate ORR assessed by the investigator based on the Response Evaluation Criteria in Solid Tumors RECIST version 11
Subjects in Cohort 1 will receive LM-108 monoclonal antibody combined with sintilimab Subjects in Cohort 2 will receive LM-108 monoclonal antibody combined with sintilimab and chemotherapy for 4-6 cycles LM-108 monoclonal antibody combined with sintilimab will be maintained and the choice of chemotherapy regimen and the duration of use will be determined by the investigator Treatment will continue until disease progression unacceptable toxicity initiation of a new anti-tumor therapy withdrawal of informed consent loss to follow-up death or other investigator-determined reasons for discontinuation whichever occurs first with a maximum treatment duration of 24 months The primary study endpoint is the objective response rate ORR assessed by the investigator based on the Response Evaluation Criteria in Solid Tumors RECIST version 11
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