MetLung

A Randomized, Phase III, Multicenter, Double-Blined, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab(MetMAb) in Combination With Tarceva(Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell LungCancer (NSCLC) Who Have Received Standard Chemotherapy For Advanced or Metastatic Disease

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221908

Enrollment

490

Registered

2012-09-04

Start date

2012-09-04

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 : PRO143966[MetMAb], erlotinib[Tarceva] INN of investigational material : onartuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Adm

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients, >/= 18 years of age - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Histologically or cytologically confirmed incurable Stage IIIb/IV NSCLC tumor - Met diagnostic-positive status tested by IHC - Results of EGFR-activating mutation testing - Radiographic evidence of disease - Prior treatment with at least one platinum-based line of treatment (for stage IIIb/IV) and no more than one additional line of chemotherapy treatment

Exclusion criteria

Exclusion criteria: - More than 30 days of exposure to an investigational or marketed agent that can act by EGFR inhibition, or a known EGFR-related toxicity resulting in dose modifications - 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.Patients with prior history of non-invasive cancers are eligible. - Inadequate hematological, biochemical or organ function - Significant history of cardiac disease - Serious active infection at time of randomization (This includes patients known to be HIV-positive or patients with known active hepatitis B or C ) or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment - Any inflammatory changes of the surface of the eye - Clinically significant gastro-intestinal disease, including uncontrolled inflammatory gastro-intestinal diseases - Pregnant or lactating women

Design outcomes

Primary

Measure	Time frame
Overall survival	—

Secondary

Measure	Time frame
- Progression-free survival - Overall response rate - Safety: Incidence of adverse events RECIST version1.1	—

Outcome results

None listed

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