Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06514027
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Study of BEBT-109 in Subjects With Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 Phase II clinical study to evaluate the efficacy safety and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced recurrent or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations
Detailed Description:
This study initially sets up two cohorts In cohort 1 the treatment is BEBT-109 combined with investigator-selected chemotherapy injectable pemetrexed disodium combined with carboplatin or cisplatin injection In cohort 2 the treatment is BEBT-109 monotherapy BEBT-109 capsule at a dose of 180mg taken orally once daily Based on different dosing regimens of BEBT-109 capsules cohort 1 is divided into three dose groups A BEBT-109 capsule at a dose of 180mg taken orally once daily B BEBT-109 capsule at a dose of 120mg taken orally twice daily and C BEBT-109 capsule at a dose of 120mg taken orally once daily Dose group A will first enroll six subjects to receive one cycle a treatment cycle is 21 days of drug treatment and the safety data of subjects in dose group A will determine whether to adjust the dose for cohort 1 or to initiate other dose groups If 2 subjects experience dose-limiting toxicity DLT during the DLT observation period dose group A will be expanded to 20-30 subjects and the decision to initiate dose group B will be made jointly by the investigators and the sponsor If more than 2 subjects experience DLT the decision to continue the study or to initiate dose group C will be made jointly by the investigators and the sponsor Subjects in dose groups B and C will also initially enroll six subjects to undergo DLT safety follow-up and then the decision to expand to 20-30 subjects will be made jointly by the investigators and the sponsor
The decision to initiate cohort 2 will be based on the safety and efficacy results from cohort 1
Each subjects study process includes three phases screening treatment and follow-up During the treatment period subjects will undergo tumor assessments every 6 weeks 7 days After discontinuing treatment subjects will enter the follow-up period where subjects without progressive disease PD will receive efficacy follow-up every 6 weeks 7 days until tumor progression death or other antitumor treatment is initiated and survival follow-up every 3 months 2 weeks All subjects will receive study drug treatment until PD death intolerable toxicity occurs or the subject withdraws informed consent whichever occurs first
The decision to initiate cohort 2 will be based on the safety and efficacy results from cohort 1
Each subjects study process includes three phases screening treatment and follow-up During the treatment period subjects will undergo tumor assessments every 6 weeks 7 days After discontinuing treatment subjects will enter the follow-up period where subjects without progressive disease PD will receive efficacy follow-up every 6 weeks 7 days until tumor progression death or other antitumor treatment is initiated and survival follow-up every 3 months 2 weeks All subjects will receive study drug treatment until PD death intolerable toxicity occurs or the subject withdraws informed consent whichever occurs first
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