Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380348
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-09
Brief Title:
JMT101 in Combination With Osimertinib Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer NSCLC Characterized by Epithermal Growth Factor Receptor EGFR Exon 20ins Mutations
Sponsor:
Shanghai JMT-Bio Inc
Organization:
Shanghai JMT-Bio Inc
Study Overview
Official Title:
A Randomized Open-label Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
This is a multicenter randomized open-label parallel-controlled phase 3 study This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy
Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by Independent Review CenterIRC-assessed Progression Free Survival PFS per RECIST 11 as primary endpoint Approximately 398 participants are estimated to be randomized into the study Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 11 manner stratified by baseline brain metastasis withwithout and Eastern Cooperative Oncology Group ECOG Performance Status PS 0 versus 1
Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by Independent Review CenterIRC-assessed Progression Free Survival PFS per RECIST 11 as primary endpoint Approximately 398 participants are estimated to be randomized into the study Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 11 manner stratified by baseline brain metastasis withwithout and Eastern Cooperative Oncology Group ECOG Performance Status PS 0 versus 1
Detailed Description:
None
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