Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05361564
Status:
UNKNOWN
Last Update Posted:
2022-05-04
First Post:
2022-04-29
Brief Title:
A Window of Opportunity Study for Investigating Drug Tolerant Persister DTP to Preoperative Brigatinib in Resectable Non-small Cell Lung Cancer NSCLC Harboring ALK Fusions
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
A Window of Opportunity Study for Investigating Drug Tolerant Persister DTP to Preoperative Brigatinib in Resectable Non-small Cell Lung Cancer NSCLC Harboring ALK Fusions
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
NOT_YET_RECRUITING
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 study is single arm open label phase II trial for resectable ALK NSCLC Eligible patients will receive brigatinib after 7-day lead-in 90mg from 4 to 10 weeks
The objective of this study is as follows
Primary objective To identify molecular mechanism of DTP causing innate drug resistance to neoadjuvant brigatinib in resectable NSCLC harboring ALK fusion by analyzing single cell RNA-seq
Secondary objectives
1 To assess the pathologic response rate to neoadjuvant treatment with Brigatinib
2 To evaluate the clinical efficacy in resectable ALK-positive NSCLC patients treated with brigatinib induction therapy
3 To evaluate the successful curative resection rate
4 To evaluate the safety of brigatinib as neoadjuvant treatment in resectable ALK-rearranged NSCLC patients
5 To investigate the changes of ALK rearrangement and other hot spot mutations by GUARDANT LUNAR assay of circulating tumor DNA present in blood plasma immediately with serial sampling
6 To assess of variant allele frequencies between pre-treatment and post-treatment sampling by GUARDANT LUNAR assay
7 To explore cell-free biomarkers that may be predictive of response or primary resistance to brigatinib neoadjuvant therapy
The objective of this study is as follows
Primary objective To identify molecular mechanism of DTP causing innate drug resistance to neoadjuvant brigatinib in resectable NSCLC harboring ALK fusion by analyzing single cell RNA-seq
Secondary objectives
1 To assess the pathologic response rate to neoadjuvant treatment with Brigatinib
2 To evaluate the clinical efficacy in resectable ALK-positive NSCLC patients treated with brigatinib induction therapy
3 To evaluate the successful curative resection rate
4 To evaluate the safety of brigatinib as neoadjuvant treatment in resectable ALK-rearranged NSCLC patients
5 To investigate the changes of ALK rearrangement and other hot spot mutations by GUARDANT LUNAR assay of circulating tumor DNA present in blood plasma immediately with serial sampling
6 To assess of variant allele frequencies between pre-treatment and post-treatment sampling by GUARDANT LUNAR assay
7 To explore cell-free biomarkers that may be predictive of response or primary resistance to brigatinib neoadjuvant therapy
Detailed Description:
This study is single arm open label phase II trial for resectable ALK NSCLC Eligible patients will receive brigatinib after 7-day lead-in 90 mg from 4 to 10 weeks The surgery with curative intent will be performed within 4 - 10 weeks after initiating brigatinib optimal duration 6 weeks The surgery with curative intent represents more than sublobar resection with mediastinal lymph node dissection Patients take it up to the day before surgery and can be allow stop up to 3 days before surgery by physicians discretion
Post-operative adjuvant treatment will be conducted based on the treating physicians best medical judgement
Brigatinib will be administered orally at a dose of 90 mg QD for the first 7 days Patients who have tolerated the 90 mg starting dose on Days 1 through 7 will be expected to increase their dose to 180 mg QD beginning on Day 8 and continuously every day with a 28-day study procedure execution cycle The study drug shall be taken approximately at the same time of the day each day It may be taken with or without food Patients shall be instructed to swallow the tablets whole and not crush or chew them Patients will take the dose with water recommended 240 mL If a dose of brigatinib is missed or vomiting occurs after taking a dose do not administer an additional dose and take the next dose of brigatinib at the scheduled time
The patients daily dose of brigatinib should not be increased to 180 mg if any of the following adverse reactions are experienced during treatment at 90 mg QD
Interstitial lung disease ILDpneumonitis any grade
Symptomatic bradycardia Grade 2 or greater
Grade 2 or higher visual disturbance
Any other Grade 3 or higher adverse reaction
Post-operative adjuvant treatment will be conducted based on the treating physicians best medical judgement
Brigatinib will be administered orally at a dose of 90 mg QD for the first 7 days Patients who have tolerated the 90 mg starting dose on Days 1 through 7 will be expected to increase their dose to 180 mg QD beginning on Day 8 and continuously every day with a 28-day study procedure execution cycle The study drug shall be taken approximately at the same time of the day each day It may be taken with or without food Patients shall be instructed to swallow the tablets whole and not crush or chew them Patients will take the dose with water recommended 240 mL If a dose of brigatinib is missed or vomiting occurs after taking a dose do not administer an additional dose and take the next dose of brigatinib at the scheduled time
The patients daily dose of brigatinib should not be increased to 180 mg if any of the following adverse reactions are experienced during treatment at 90 mg QD
Interstitial lung disease ILDpneumonitis any grade
Symptomatic bradycardia Grade 2 or greater
Grade 2 or higher visual disturbance
Any other Grade 3 or higher adverse reaction
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