title: A multicenter randomized phase IIb efficacy study of Vx-001, a peptide-based cancer vaccine as maintenance treatment in advanced non-small-cell lung cancer: treatment rationale and protocol dynamics.
abstract: We present the treatment rationale and study design of a multicenter, open-label, randomized, 2-arm, phase IIb study. Patients with stage IV or recurrent stage I to III non-small-cell lung cancer (NSCLC) whose disease does not progress after 4 cycles of first-line platinum-based chemotherapy will be randomized in a 1:1 ratio to 1 of 2 study arms. Patients will receive the cancer vaccine Vx-001 + Montanide ISA51 VG (Seppic, Paris, France) adjuvant subcutaneously, at a dose of 2 mg, or placebo + Montanide ISA51 VG adjuvant subcutaneously. The vaccination protocol comprises 2 injections with the TYR-Vx001 or placebo (1 at day 0 and another at week 3) and 4 injections with the ARG-Vx001 or placebo, at weeks 6, 9, 12, and 15. After the treatment assessment at week 18, patients will receive the ARG-Vx001 or placebo every 12 weeks starting from week 27 until disease progression, unacceptable toxicity, withdrawal of informed consent, or death. The primary end point of this study is the survival rate at 12 months. Secondary end points include time-to-event comparison of overall survival and comparison of time to treatment failure. Exploratory objectives include comparison of disease control rate after the end of subsequent second-line treatments, comparisons of vaccine immune responses, comparison of survival rate at 12 months in patients with vaccine-induced immune response detected after the second and sixth injections, identification of biomarkers on lymphocytes and on tumors, and comparison of safety and tolerability.
authors: Department of Medical Oncology, University General Hospital of Heraklion, Crete, Greece.
authors: Vassilis
authors: V
authors: Georgoulias
authors: Jean-Yves
authors: JY
authors: Douillard
authors: David
authors: D
authors: Khayat
authors: Christian
authors: C
authors: Manegold
authors: Rafael
authors: R
authors: Rosell
authors: Antonio
authors: A
authors: Rossi
authors: Jeanne
authors: J
authors: Menez-Jamet
authors: Marina
authors: M
authors: Iché
authors: Kostas
authors: K
authors: Kosmatopoulos
authors: Cesare
authors: C
authors: Gridelli
mesh_terms: D000293:Adolescent; D019496:Cancer Vaccines / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000473:pathology / Q000628:therapy*; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D007390:International Agencies; D008175:Lung Neoplasms / Q000473:pathology / Q000628:therapy*; D009364:Neoplasm Recurrence, Local / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D010446:Peptide Fragments / Q000627:therapeutic use*; D011379:Prognosis; D019098:Telomerase / Q000627:therapeutic use*
chemical_list: D019496:Cancer Vaccines; D010446:Peptide Fragments; D019098:Telomerase; C521181:telomerase reverse transcriptase p572Y, human