A RANDOMIZED, PHASE III, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF ONARTUZUMAB IN COMBINATION WITH ERLOTINIB AS FIRST-LINE TREATMENT FOR PATIENTS WITH MET-POSITIVE UNRESECTABLE STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER (NSCLC) CARRYING AN ACTIVATING EGFR MUTATION

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222323

Enrollment

300

Registered

2013-12-10

Start date

2013-12-10

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 : Onartuzumab[MetMAb, PRO143966] + Erlotinib[Tarceva] INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients, >/= 18 years of age - Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC) - No prior treatment for unresectable Stage IIIB or IV NSCLC - Measurable radiographic evidence of disease according to RECIST v1.1 - ECOG performance status of 0 or 1

Exclusion criteria

Exclusion criteria: - Prior exposure to agents targeting either the HGF or MET pathway - Exposure to an investigational or marketed agent that can act by EGFR inhibition - Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently - Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for >/= 14 days - History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free - Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions - Inadequate hematologic, biochemical, and organ function - Pregnant or lactating women - Life expectancy of < 12 weeks - Receipt of an investigational drug within 28 days prior to initiation of study treatment

Design outcomes

Primary

Measure	Time frame
Progression-free survival (investigator-assessed) RECIST v1.1	—

Secondary

Measure	Time frame
- Overall survival, Overall response rate, Time to deterioration, Patient reported outcomes - Safety: Incidence of adverse events - Pharmacokinetics of Onartuzumab RECIST v1.1, EORTC QLC-C30/EORTC QLQ-LC13 questionnaires	—

Outcome results

None listed

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