HER2-mutant Non-Small Cell Lung Cancer Clinical Trial
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
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.
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 and documented somatic HER2 mutations. Patients
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 neratinib monotherapy arm
given option to add temsirolimus 8 mg IV once weekly.
Patients on combination therapy given option to dose-escalate temsirolimus to 15 mg/week at
the end of first cycle of treatment, if well tolerated and at the physician's discretion. If
neratinib 240 mg/day plus temsirolimus 15 mg/week dose not well tolerated, patient
subsequently dose reduced back to neratinib 240 mg/day plus temsirolimus 8 mg/week.
Dosing continuous on nominal 3-week cycles until evidence of progressive disease,
unacceptable toxicity, or patient withdrawal of consent.
Disease measured radiographically at baseline and every 6 weeks until disease progression or
withdrawal from the study.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05246514 -
A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC
|
Phase 2 |