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A PHASE II STUDY OF PRO143966 IN COMBINATION WITH Ro50-8231 AS A FIRST LINE THERAPY IN PATIENTS WITH MET-POSITIVE AND EGFR MUTATION POSITIVE NON-SMALL CELL LUNG CANCER (MATERIAL study)

A PHASE II STUDY OF PRO143966 IN COMBINATION WITH Ro50-8231 AS A FIRST LINE THERAPY IN PATIENTS WITH MET-POSITIVE AND EGFR MUTATION POSITIVE NON-SMALL CELL LUNG CANCER (MATERIAL study)

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222031
Enrollment
62
Registered
2013-02-26
Start date
2013-02-26
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] INN of investigational material : onartuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Inve

Sponsors

Chugai Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Aged >=20 years at informed consent - ECOG PS of 0 or 1 - Histologically or cytologically confirmed non-small cell lung cancer - Stage IIIB or IV, or postoperatively recurrent non-small cell lung cancer - Exon 19 deletions or L858R mutation on Exon 21 confirmed - Confirmed Met-positive status - Chemotherapy-naive etc.

Exclusion criteria

Exclusion criteria: - Metastases to the central nervous system, symptomatic or requiring treatment - Another malignancy with disease-free interval of less than 5 years - Radiologically evident interstitial lung disease or concomitant infection, or a history of these - Concurrent uncontrolled hypercalcaemia - Concurrent clinically significant cardiac desease - Concurrent uncontrolled diabetes mellitus - Evident diverticulitis - Clinically significant corneal disease - Concurrent superior vena cava syndrome - Clinically significant liver disease, or a history thereof etc.

Design outcomes

Primary

MeasureTime frame
Progression-free Survival (investigator-assessed), Safety

Secondary

MeasureTime frame
- Response rate, Disease control rate, Overall survival, Duration of response - Pharmacokinetics of PRO143966 - Anti-therapeutic antibodies

Outcome results

None listed

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