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A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib (ATTENTION)

A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects with Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer with Wild-type Epidermal Growth Factor Receptor (ATTENTION)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221484
Enrollment
Unknown
Registered
2011-06-20
Start date
2011-06-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell lung cancer

Interventions

investigational material(s) Generic name etc : ARQ 197 INN of investigational material : tivantinib Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type EGFR. - Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, Version 1.1. - Received one or two prior lines of systemic anti-cancer therapy for advanced or metastatic disease, one of which must be a platinum-based therapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Demonstrate adequate bone marrow, liver, and renal functions.

Exclusion criteria

Exclusion criteria: - Prior therapy with an EGFR inhibitor and/or c-Met inhibitor. - Any systemic anti-tumor treatment for NSCLC within 4 weeks prior to randomization. - Major surgical procedure within 4 weeks prior to randomization - Known symptomatic brain metastases.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS)—

Secondary

MeasureTime frame
Progression free survival (PFS) Objective response rate (ORR) Disease control rate (DCR) Safety: adverse event—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026