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)

Phase 2

• Conditions: on-Small Cell Lung Cancer

• Registration Number: JPRN-jRCT2080222031
• Lead Sponsor: Chugai Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-26
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 62

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (investigator-assessed), Safety

Secondary Outcome Measures

Name	Time	Method
- Response rate, Disease control rate, Overall survival, Duration of response<br>- Pharmacokinetics of PRO143966<br>- Anti-therapeutic antibodies