Ignite Creation Date:
2024-05-06 @ 8:29 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391944
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-26
Brief Title:
JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-small Cell Lung Cancer NSCLC Characterized by Epithermal Growth Factor Receptor EGFR Common Mutations
Sponsor:
Shanghai JMT-Bio Inc
Organization:
Shanghai JMT-Bio Inc
Study Overview
Official Title:
A Phase 2 Open Label Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Osimertinib in Patients With Stage Ⅲb-Ⅳ Non-Small Cell Lung Cancer With EGFR Common Mutations
Status:
ACTIVE_NOT_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 was a multicenter open-label phase 2 study This study aimed to evaluate the efficacy and safety of JMT101 combined with Osimertinib in participants with local advanced or metastatic non-small-cell lung cancer harbouring EGFR common mutation with or without prior systemic therapy
Efficacy indexes included investigator-assessed Overall Response RateORR Disease Control RateDCR Duration of Response DoR Progression Free Survival PFS per RECIST 11 and Overall Survival OS Safety indexes included Adverse Events incidence and severity This study included 4 cohorts cohort 1 included EGFR-mutated advanced NSCLC patients without prior systemic therapy and accepted JMT101 6mgKg Q3W and Osimertinib 80mg QD therapy Cohort 2 included EGFR-mutated advanced NSCLC patients who failed with prior generation 1 or 2 EGFR-TKIs therapy and accepted JMT101 6mgKg Q2W and Osimertinib 80mg QD therapy Cohort 3 included advanced EGFR common mutation NSCLC patients who failed with prior generation 3 EGFR-TKIs but did not accept chemotherapy and accepted JMT101 6mgKg Q2W and Osimertinib 80mg or 160mg QD therapy Cohort 4 included EGFR-mutated advanced EGFR NSCLC patients who failed with prior generation 3 EGFR-TKIs and platinum-based chemotherapy and accepted JMT101 6mgKg Q2W and Osimertinib 80mg or 160mg QD therapy
Efficacy indexes included investigator-assessed Overall Response RateORR Disease Control RateDCR Duration of Response DoR Progression Free Survival PFS per RECIST 11 and Overall Survival OS Safety indexes included Adverse Events incidence and severity This study included 4 cohorts cohort 1 included EGFR-mutated advanced NSCLC patients without prior systemic therapy and accepted JMT101 6mgKg Q3W and Osimertinib 80mg QD therapy Cohort 2 included EGFR-mutated advanced NSCLC patients who failed with prior generation 1 or 2 EGFR-TKIs therapy and accepted JMT101 6mgKg Q2W and Osimertinib 80mg QD therapy Cohort 3 included advanced EGFR common mutation NSCLC patients who failed with prior generation 3 EGFR-TKIs but did not accept chemotherapy and accepted JMT101 6mgKg Q2W and Osimertinib 80mg or 160mg QD therapy Cohort 4 included EGFR-mutated advanced EGFR NSCLC patients who failed with prior generation 3 EGFR-TKIs and platinum-based chemotherapy and accepted JMT101 6mgKg Q2W and Osimertinib 80mg or 160mg QD therapy
Detailed Description:
Avoid duplicating information that will be entered elsewhere such as Eligibility Criteria or Outcome Measures
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