Phase 2 study of ARQ 197 plus erlotinib

A phase 2, multicenter, open-label, single-arm study of ARQ 197 plus erlotinib in patient with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221766

Enrollment

Registered

2012-04-16

Start date

2012-04-16

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 Investigationa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key Inclusion Criteria: - Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation. - Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function

Exclusion criteria

Exclusion criteria: Key Exclusion Criteria: - Prior therapy with a c-Met inhibitor. - Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization. - Major surgical procedure within 4 weeks prior to randomization - Known symptomatic brain metastases.

Design outcomes

Primary

Measure	Time frame
Objective Response Rate RECIST ver. 1.1	—

Secondary

Measure	Time frame
- Progression free survival - Overall survival - Disease control rate - Number of patients with adverse events RECIST ver. 1.1, CTCAE ver. 4.0	—

Outcome results

None listed

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