Ignite Creation Date:
2024-05-06 @ 10:43 AM
Last Modification Date:
2024-10-26 @ 12:34 PM
Study NCT ID:
NCT03333343
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-02
First Post:
2017-10-31
Brief Title:
Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase Ib Open Label Multi-center Study to Characterize the Safety Tolerability and Preliminary Efficacy of EGF816 in Combination With Selected Targeted Agents in EGFR Mutant NSCLC
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
The study purpose is to evaluate the safety tolerability and preliminary efficacy of the addition of INC280 trametinib ribociclib gefitinib or LXH254 to EGF816 in adult patients with advanced EGFR-mutant NSCLC
Detailed Description:
This is a Phase Ib open label non-randomized dose escalation study of EGF816 in combination with ribociclib trametinib or LXH254 followed by dose expansion of EGF816 in combination with ribociclib trametinib LXH254 INC280 or gefitinib in adult patients with advanced EGFR-mutant NSCLC
During the dose escalation part patients will be assigned to the addition of trametinib ribociclib or LXH254 to EGF816
Following determination of the recommended dose for the combination of EGF816 trametinib EGF816 ribociclib and EGF816 LXH254 patients may be enrolled to the dose expansion arms of each of these combinations Patients may also be assigned to EGF816 INC280 or EGF816 gefitinib in dose expansion
Efficacy assessments will be performed at baseline and every 2 cycles during treatment
During the dose escalation part patients will be assigned to the addition of trametinib ribociclib or LXH254 to EGF816
Following determination of the recommended dose for the combination of EGF816 trametinib EGF816 ribociclib and EGF816 LXH254 patients may be enrolled to the dose expansion arms of each of these combinations Patients may also be assigned to EGF816 INC280 or EGF816 gefitinib in dose expansion
Efficacy assessments will be performed at baseline and every 2 cycles during treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002496-25 | EUDRACT_NUMBER | None | None |