Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563999
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Neoadjuvant Umbrella Trial for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations Without EGFR Sensitizing Mutations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NUMER
Brief Summary:
This umbrella trial directed by next generation sequencing NGS includes patients with treatment-naive unresectable stage III non-small-cell lung cancer NSCLC The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation
Detailed Description:
Stage III non-small-cell lung cancer NSCLC patients account for about one-third of newly diagnosed NSCLC with a large population and strong heterogeneity posing significant challenges for clinical treatment Concurrent chemoradiotherapy plus immune checkpoint inhibitors is the recommended therapeutic approach for patients with unresectable stage III non-small cell lung cancer NSCLC although surgery offers the chance of cure However existing evidence suggests that patients with driver mutation positive NSCLC have limited benefits from immunotherapy There is still controversy over the definition of unresectable and some stage IIIA and specific stage IIIB-N2 patients may also benefit from comprehensive surgical treatment Emerging data supports the use of targeted therapies in NSCLC patients with a rare mutation The aim of this umbrella study is to explore the efficacy of induction next generation sequencing NGS-directed targeted therapies followed by surgery for unresectable stage III NSCLC patients whose tumor harbors a rare mutation Without EGFR Sensitizing Mutations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None