Dacomitinib + Pemetrexed for Patients With Advanced Non-squamous Non-small Cell Lung Cancer (NSCLC)

Phase 1

Terminated

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Dacomitinib, Pemetrexed

• Registration Number: NCT01918761
• Lead Sponsor: Central European Cooperative Oncology Group

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-27
• Study Start: 2013-07-30
• Study First Submitted QC: 2013-08-07
• Study First Posted: 2013-08-08
• Primary Completion: 2016-09-15
• Study Completion: 2016-09-15
• Status Verified: 2018-01
• Results First Submitted: 2019-11-21
• Results First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Results First Posted: 2019-12-30
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dacomitinib, Pemetrexed	Dacomitinib, Pemetrexed	Pemetrexed 500mg/m2 (i.v) q21d Dacomitinib 45mg/ orally (continuous)

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicities (DLTs)	From start of treatment to end of treatment or death, whichever occurs first. The study was suspended after 36 months.	The primary objective of this study is to determine the maximal tolerated dose (MTD) of the combination pemetrexed + dacomitinib by the incidence of dose limiting toxicities (DLTs).

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Until progression of disease (PD) or 24 month after end of treatment for participants with no PD. The study was suspended after 36 months	Overall Response Rate (ORR) is defined as the proportion of patients with complete Response (CR) or partial Response (PR).
Progression-free Survival	Up to progression or death due to any cause. The study was suspended after 36 months	Progression-free survival (PFS) defined as time from start of Dacomitinib to date of progression or date of death from any cause, whichever occurred first. Patients without recorded progression or death were censored at the last date they were known to have not progressed. Patients were followed up for progression-free survival for 24 month after end of Treatment.
Overall Survival	until date of death. The study was suspended after 36 months.	Overall survival (OS) defined as time from start of Dacomitinib to date of death from any cause. Patients without recorded death were censored at the date the patient was last known to be alive. Patients were followed up for survival for 24 month after end of Treatment.

Trial Locations

Locations (2)

Medizinische Universität Graz Klinische Abteilung für Onkologie; 🇦🇹 Graz, Austria

Universitätsklinik für Innere Medizin I; 🇦🇹 Innsbruck, Austria