Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06054191
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2023-09-19
Brief Title:
Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Phase II Two Parallel Group Study of Neoadjuvant and Adjuvant Targeted Treatment in NSCLC With BRAF V600 or MET Exon 14 Mutations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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 Phase II two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations
Detailed Description:
This is a Phase II two parallel group study assessing the efficacy and safety of neoadjuvant and adjuvant targeted therapy in patients with stage IB-IIIA NSCLC harboring BRAF V600 or MET exon14 mutations Eligible patients with BRAF V600 mutations will receive dabrafenib 150mg bid plus trametinib 2mg qd for 8 weeks before a surgical resection neoadjuvant and followed by up to 4 cycles of adjuvant chemotherapy if receive adjuvant chemotherapy up to four cycles chemo regimen according to investigators choice and up to 2 years of adjuvant targeted therapy with dabrafenib plus trametinib For patients with MET exon14 mutations they will receive capmatinib 400mg bid for 8 weeks before surgery neoadjuvant followed by up to 4 cycles of adjuvant chemotherapy about adjuvant chemotherapy same as BRAF V600 group and up to 2 years of adjuvant targeted therapy with capmatinib post-surgery During treatment patients will visit their physicians regularly for disease and safety assessment After the end of treatment survival follow-up will be conducted every 3 months for up to 3 years Approximately 40 evaluable patients will be enrolled in the study 20 patients in each cohort
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