Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BIBW 2992MA2, Gilotrif
Afatinib Dimaleate · 1 trial · 4 indications
MTD is defined as the dose were less than two patients experienced a dose limiting toxicity. Dose limiting toxicities are defined in the protocol and graded per CTCAE 4.0.
| Arm | Type | Description |
|---|---|---|
| Arm I (afatinib dimaleate, pembrolizumab) | EXPERIMENTAL | DOSE DE-ESCALATION COHORT: Patients receive afatinib dimaleate PO QD on days 1-21 and pembrolizumab IV over 30 minutes on day 1. Courses repeat every 21 days (for up to 2 years for pembrolizumab) in the absence of disease progression or unacceptable toxicity. 6 patients were enrolled into Dose Level 0 at 40 mg QD of afatinib, no de-escalation was needed prior to expansion. |
| Arm II (pembrolizumab, afatinib dimaleate) | EXPERIMENTAL | EXPANSION COHORT: Patients receive pembrolizumab IV over 30 minutes on day 1 for 2 courses. Beginning course 3, patients receive afatinib dimaleate PO and pembrolizumab IV as in Arm I. Courses repeat every 21 days (up to 2 years for pembrolizumab) in the absence of disease progression or unacceptable toxicity. All five expansion patients were enrolled at the dose of 40 mg QD of Afatinib. |
| Name | Type | Description |
|---|---|---|
| Afatinib Dimaleate | DRUG | Given PO |
| Pembrolizumab | BIOLOGICAL | Given IV |
Inclusion Criteria: * Incurable, advanced or metastatic/recurrent non-small cell lung cancer with EGFR activating mutations (exon 19 del, exon 21 L858R, L861Q, G718X); who have radiologic and/or clinically progressive disease on erlotinib at any point during the patient's cancer treatment as determ...