Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small … (NCT01827267) | Clinical Trial Compass
CompletedPhase 2
Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
United States62 participantsStarted 2013-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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).
✓. Patients with anaplastic lymphoma kinase (ALK) translocations must have received crizotinib, except for cases of intolerable toxicity to crizotinib.
✓. At least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).
✓. Eastern Cooperative Oncology Group (ECOG) status \<2.
✓. Left ventricular ejection fraction (LVEF) ≥50% measured by multiple -gated acquisition scan (MUGA) or echocardiogram (ECHO).
✓. Negative β-human chorionic gonadotropin (hCG) pregnancy test for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after menopause.
Exclusion criteria
✕. Previous treatment with any investigational agent ≤14 days prior to the initiation of investigational products.
✕. Previous treatment with any strong inhibitor and/or inducer of CYP3A4 enzyme or sensitive P-glycoprotein (P-gp) substrates ≤30 days prior to the initiation of investigational products.
✕. Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of ≥2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: From randomization to last tumor assessment, assessed up to 116.5 weeks. For the Neratinib arm, only tumor assessments prior to crossover were included.