Phase 1b study of Process 2 Patritumab in combination with erlotinib in subjects with advanced non-small cell lung cancer (NSCLC)

Phase 1

• Conditions: Advanced NSCLC has progressed on at least one prior chemotherapy

• Registration Number: JPRN-jRCT2080222789
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1) Histologically or cytologically diagnosed advanced NSCLC has progressed on at least one prior chemotherapy
2) Stage IIIB or IV disease
3) ECOG performance status: 0-1

Exclusion Criteria

1) Has history of anti-HER3 therapy
2) Patients with active other malignancies
3) Has history or complication of any of the following diseases: interstitial lung disease, heart failure, myocardial infarction, cerebral infarction, active angina, arrhythmia requiring medication, coronary/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thrombosis, deep vein thrombosis, other clinically significant thromboembolic events, diverticulitis, or clinically significant pulmonary disease (e.g., lung infection, COPD, or asthma)
4) Patients with any severe or uncontrolled comorbid medical conditions in spite of medications
5) Has brain metastasis with clinical symptoms or requiring treatment
6) Has history of bleeding diathesis (e.g., hemoptysis)
7) Has history of serious drug hypersensitivity such as anaphylactoid reaction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety<br>CTCAE ver. 4.03

Secondary Outcome Measures

Name	Time	Method
1) Pharmacokinetics<br>2) Preliminary assessment of anti-tumor activity of U3-1287<br>3) Incidence of anti-U3-1287 antibody<br>4) Exploratory study on U3-1287-related biomarkers<br>RECIST ver. 1.1