Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC Stage IV Pemetrexed Dacomitinib
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief summary:
To identify a dose of dacomitinib in combination with pemetrexed that is safe and tolerated as determined by the incidence of DLTs (dose limiting toxicities).

Detailed description:
This open label phase Ib trial aims to determine the safety, tolerability, the pharmacokinetic profile, and to identify a dose of dacomitinib in combination with pemetrexed.

Three sites in Austria will participate in this study. Six to nine patients will initially be enrolled to receive the target dose of 45 mg qd dacomitinib (starting from day 2 of first cycle) in combination with pemetrexed (500 mg/m² 10 min infusion, once every 3 weeks). One cycle is defined as 21 days.

The first 3 subjects will be enrolled at a rate of ≤ 1 subject per week. If the target dose regimen is safe based on the incidence of DLT another 3 subjects will be enrolled.

If the dose of 45 mg qd is not safe alternate lower doses will be explored (dose level -1, dose level -2) to identify the maximal tolerated dose (MTD) of dacomitinib in combination of pemetrexed. Six to nine patients per dose level will be enrolled.

Arms:
arm 1: Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Interventions: intervention 1: Dacomitinib, Pemetrexed
Intervention descriptions: intervention 1: Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)

Protocol document: