Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652048
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
High-dose Furmonertinib or Combined with Chemotherapy in EGFR-mutant Advanced NSCLC After Disease Progression on Third-generation EGFR-TKI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
High-dose Furmonertinib or Combined with Pemetrexed and Carboplatincisplatin in EGFR-sensitive Mutation Advanced NSCLC After Disease Progression on First-line Treatment of Third-generation EGFR-TKIa Multicenceropen-labelrandomized Phase II Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
This is a multicenter open-labelrandomised phase II study planned to include 60 subjects with EGFR-sensitive mutation advanced NSCLC after disease progression on first-line treatment with third-generation EGFR-TKIEligible patients will randomly be assigned in a 111 ratio to receive 160mg240mg furmonertinib po qd or 160mg furmonertinib po qd plus chemotherapycarboplatin AUC 5 cisplatin 75mgm2 pemetrexed 500mgm2 every 21 days 4 cycles pemetrexed 500mgm2 every 21 days maintenancePatients will be followed up every 2 cycles during the first half year and every 3 cycles after the first half yearTreatment was continued until disease progressionintolerable toxic effects investigator decision patient withdrawal of consent or death whichever occurred first
Detailed Description:
None
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