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P1.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 206)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Coordinates: 9/07/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
P1.01-081 - Patritumab Plus Erlotinib in EGFR Wild-Type Advanced Non-Small Cell Lung Cancer: A 2-Part Phase 3 Study (HER3-Lung) (ID 2205)
09:30 - 17:00 | Author(s): D. Shuster
Patritumab (P) is a fully human monoclonal antibody directed against human epidermal growth factor receptor 3 (HER3) that blocks activation by the ligand, heregulin (HRG), and induces receptor internalization. A Phase 2 study (NCT01211483) demonstrated that addition of P to erlotinib (E) increased progression-free survival (PFS) for the subgroup of advanced non–small cell lung cancer (NSCLC) patients with high HRG mRNA expression (HRG-high); a generally similar safety profile was seen with P+E compared with E monotherapy. To confirm these results, P+E vs. E is being investigated in a 2-part Phase 3 study designed to further evaluate the predictiveness of the HRG biomarker in patients with advanced NSCLC (https://clinicaltrials.gov/ct2/show/NCT02134015).
HER3-Lung is randomized, placebo-controlled, double-blind, 2-part (A and B), Phase 3 study. Part A will enroll subjects with any HRG expression (limited to approximately one-third of subjects with HRG-low expression) to confirm efficacy of P+E vs. E in HRG-high disease and to possibly refine the cut-off level of HRG expression. The primary endpoint of Part A is PFS and secondary endpoints are objective response rate, overall survival, and safety. Part B will enroll subjects with HRG-high disease, defined as having a cut-off based upon the results of Part A and previous Phase 2 results. Part B is designed to independently provide pivotal confirmation of the efficacy and safety of P+E vs. E in the biomarker-defined population (n=600). The primary endpoint of Part B is overall survival. For both Part A and Part B, subjects must be aged ≥20 years with advanced NSCLC previously treated with 1 or 2 systemic therapies, and if adenocarcinoma histology, wild-type for EGFR and ALK. Tissue assessable for HRG expression must be available from archival or recently collected tumor sample. For Part A, subjects will be stratified by histology subtype, Eastern Cooperative Oncology Group performance status (0, 1) and best response to the most recent systemic therapy. Within each stratum, patients will be randomized 1:1 to P (18 mg/kg intravenous loading dose, then 9 mg/kg maintenance dose every 3 weeks) + E (150 mg/day orally) or placebo + E. Patients will be treated until disease progression, unacceptable toxicity, or withdrawal of consent.
Recruitment commenced in April 2014, and enrollment of Part A is ongoing. Investigational sites are located in Europe, United States and Canada.
This study employs an innovative design to confirm efficacy in HRG-selected subjects while evaluating the expression cut-off before pivotal confirmation of efficacy and safety in the HRG-high subpopulation of EGFR wild-type NSCLC.
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