Phase 1b study of U3-1287 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-jRCT2080221467
• Lead Sponsor: DAIICHISANKYO Co.,Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-05-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Histologically or cytologically diagnosed advanced NSCLC has progressed on at least one prior chemotherapy
-Stage IIIB or IV disease
-Measurable tumour lesions and malignant lymph nodes per RECIST ver 1.1
-ECOG performance status: 0-1

Exclusion Criteria

-Has history of erlotinib or anti-HER3 therapy
-Patients with active other malignancies
-History of any of the following diseases or comorbid medical conditions: 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)
-Patients with any severe or uncontrolled comorbid medical conditions in spite of medications
-Has brain metastasis with clinical symptoms or requiring treatment
-Has history of bleeding diathesis (e.g., hemoptysis)
-Has history of serious drug hypersensitivity such as anaphylactoid reaction

Study & Design

• Study Type: Interventional
• Study Design: Not specified