Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03333343 | Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC | PHASE1 | ACTIVE NOT_RECRUITING | 105 | — | — | Jan 29, 2018 | Oct 5, 2026 | Jan 16, 2026 | 11 | Canada, Germany +4 |
Assess safety and tolerability including incidence of dose limiting toxicities, adverse events, and serious adverse events.
A Dose-Limiting Toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of combination treatment during the dose escalation part of the study. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments may be permitted in order to allow patients to continue the study treatment.
Dose intensity is computed as the ratio of actual cumulative dose received to actual duration of exposure.
Modified objective response rate (ORR2) per RECIST v1.1 (taking as baseline the most recent assessment prior to initiating combination)
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | EGF816+ trametinib in escalation phase |
| Arm 2 | EXPERIMENTAL | EGF816 + ribociclib in escalation phase |
| Arm 3 | EXPERIMENTAL | EGF816 + LXH254 in escalation phase |
| Arm A | EXPERIMENTAL | EGF816 + INC280 in expansion phase (patients with no known resistance mechanism) |
| Arm B | EXPERIMENTAL | EGF816 + trametinib in expansion phase |
| Arm C | EXPERIMENTAL | EGF816 + ribociclib in expansion phase |
| Arm D | EXPERIMENTAL | EGF816 + LXH254 in expansion phase (patients with no known resistance mechanism) |
| Arm E | EXPERIMENTAL | EGF816 + LXH254 in expansion phase (patients with known resistance mechanism) |
| Arm F | EXPERIMENTAL | EGF816 + gefitinib in expansion phase |
| Arm G | EXPERIMENTAL | EGF816 + INC280 in expansion phase (patients with known resistance mechanism) |
| Name | Type | Description |
|---|---|---|
| EGF816 | DRUG | Study Drug |
| trametinib | DRUG | Study Drug |
| ribociclib | DRUG | Study Drug |
| LXH254 | DRUG | Study Drug |
| INC280 | DRUG | Study Drug |
| gefitinib | DRUG | Study Drug |
Inclusion Criteria: * Patients must have histologically or cytologically confirmed locally advanced (stage IIIB) or metastatic (stage IV) EGFR mutant (ex19del, L858R) NSCLC. * Requirements of EGFR mutation status and prior lines of treatment: * Treatment naive patients, who have locally advanced or...