Rationale and design of MARQUEE: A phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer

Giorgio V. Scagliotti, Silvia Novello, Joan H. Schiller, Vera Hirsh, Lecia V. Sequist, Jean Charles Soria, Joachim Von Pawel, Brian Schwartz, Reinhard Von Roemeling, Alan B. Sandler

Research output: Contribution to journalArticle

120 Citations (Scopus)

Abstract

We present the rationale and design for MARQUEE, a phase III, randomized, double-blind, placebo-controlled study of ARQ 197 plus erlotinib versus placebo plus erlotinib in previously treated subjects with locally advanced or metastatic, nonsquamous, Non-Small-cell lung cancer (NSCLC). The design of MARQUEE is based on preclinical data, the current understanding of the role of cellular N-methyl-N'-nitroso-guanidine human osteosarcoma (MNNG HOS) transforming gene (MET) in NSCLC, and clinical data from a randomized phase II study. The available evidence suggests that dual inhibition of MET and the epidermal growth factor receptor (EGFR) may overcome resistance to EGFR inhibitors. In the phase II study, the combination of tivantinib plus erlotinib significantly improved progression-free survival (PFS) and overall survival (OS) compared with placebo plus erlotinib in the subset of patients with nonsquamous histology, a population enriched for MET overexpression. The primary endpoint in MARQUEE is OS. Secondary and exploratory objectives include determination of PFS, OS in molecular subgroups (defined by EGFR and KRAS mutation status, amplification or overexpression of MET, and serum hepatocyte growth factor), and safety. All patients will be tested for biomarkers, and the results will provide a wealth of information on the role of tivantinib in treating nonsquamous NSCLC.

Original languageEnglish (US)
Pages (from-to)391-395
Number of pages5
JournalClinical Lung Cancer
Volume13
Issue number5
DOIs
StatePublished - Sep 2012

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Double-Blind Method
Non-Small Cell Lung Carcinoma
Placebos
Epidermal Growth Factor Receptor
Disease-Free Survival
Survival
Hepatocyte Growth Factor
Guanidine
Osteosarcoma
Oncogenes
Histology
Biomarkers
Safety
Mutation
ARQ 197
Erlotinib Hydrochloride
Serum
Population

Keywords

  • Epidermal growth factor receptor
  • Hepatocyte growth factor receptor
  • MET
  • Tyrosine kinase inhibitors

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Rationale and design of MARQUEE : A phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer. / Scagliotti, Giorgio V.; Novello, Silvia; Schiller, Joan H.; Hirsh, Vera; Sequist, Lecia V.; Soria, Jean Charles; Von Pawel, Joachim; Schwartz, Brian; Von Roemeling, Reinhard; Sandler, Alan B.

In: Clinical Lung Cancer, Vol. 13, No. 5, 09.2012, p. 391-395.

Research output: Contribution to journalArticle

Scagliotti, Giorgio V. ; Novello, Silvia ; Schiller, Joan H. ; Hirsh, Vera ; Sequist, Lecia V. ; Soria, Jean Charles ; Von Pawel, Joachim ; Schwartz, Brian ; Von Roemeling, Reinhard ; Sandler, Alan B. / Rationale and design of MARQUEE : A phase III, randomized, double-blind study of tivantinib plus erlotinib versus placebo plus erlotinib in previously treated patients with locally advanced or metastatic, nonsquamous, non-small-cell lung cancer. In: Clinical Lung Cancer. 2012 ; Vol. 13, No. 5. pp. 391-395.
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