Overview

This trial is active, not recruiting.

Condition her2-mutant non-small cell lung cancer
Treatments neratinib, temsirolimus
Phase phase 2
Targets HER, mTOR, HER2, EGFR
Sponsor Puma Biotechnology, Inc.
Start date May 2013
End date December 2015
Trial size 104 participants
Trial identifier NCT01827267, 2012-004743-68, PUMA-NER-4201

Summary

This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
240 mg neratinib
neratinib
240 mg orally, once daily with food, continuously in 21 day cycles
(Experimental)
240 mg neratinib plus 8 mg temsirolimus with optional dose escalation to 15 mg temsirolimus
neratinib
240 mg orally, once daily with food, continuously in 21 day cycles
temsirolimus Torisel
8 mg or 15 mg weekly by IV infusion

Primary Outcomes

Measure
Overall Response Rate (ORR)
time frame: minimum 21 days

Secondary Outcomes

Measure
Clinical Benefit Rate (CBR)
time frame: at least 12 weeks
Duration of Response (DOR)
time frame: Estimated 6 months
Progression Free Survival (PFS)
time frame: Estimated 6 months
Overall Survival (OS)
time frame: Estimated 12 months
Safety (Adverse Events [AEs] and Serious Adverse Events [SAEs])
time frame: Estimated 6 months
Change from baseline in quality of life measured using EQ-5D-5L and FACT-L
time frame: Estimated 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Aged ≥18 years at the time of signing the informed consent. - Histologically confirmed diagnosis of NSCLC, advanced (stage IIIB) or metastatic (stage IV). - Documented somatic ErbB2 (HER2) activating mutation. Exclusion Criteria: - Previous treatment with any investigational agent ≤30 days prior to the initiation of investigational products. - Prior exposure to neratinib or mTOR inhibitor Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Additional Information

Official title A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients With Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations
Description This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with NSCLC who have documented somatic HER2 mutations. Patients will be randomized at study entry into 1 of 2 treatment arms: - Arm A: neratinib 240 mg orally once daily, - Arm B: neratinib 240 mg orally once daily plus temsirolimus 8 mg once weekly by intravenous (IV) infusion. In the case of disease progression, patients initially assigned to the neratinib monotherapy arm will be given the option to add temsirolimus 8 mg IV once weekly. All patients on combination therapy may be dose-escalated with respect to temsirolimus dose to 15 mg/week at the end of first cycle of treatment with the combination, if well tolerated and at the physician's discretion. In the event that the neratinib 240 mg/day plus temsirolimus 15 mg/week dose is not well tolerated, the patient will be subsequently dose reduced back to neratinib 240 mg/day plus temsirolimus 8 mg/week. Dosing will be continuous on nominal 3-week cycles until evidence of progressive disease, unacceptable toxicity, or patient withdrawal of consent. All eligible patients enrolled will have their disease measured radiographically at baseline. Patients will undergo radiographic evaluation of their disease every 6 weeks until disease progression or withdrawal from the study.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Puma Biotechnology, Inc..