A Study of Trastuzumab Emtansine in Patients With HER2-Positive, Recurrent Metastatic Non-Small Cell Lung Cancer

Not Applicable

• Conditions: HER2-positive, recurrent, non-small cell lung cancer (NSCLC)

• Registration Number: JPRN-UMIN000017709
• Lead Sponsor: Okayama University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

(1)History of intolerance or hypersensitivity to investigational agent or any excipient of the product (2)Current pregnancy or lactation (3)Refusal of use of highly effective contraception (4)Evidence of active pneumonitis during screening or its history, except for pulmonary fibrosis in the radiation field induced by prior thoracic irradiation (5)Left ventricular ejection fraction (LVEF) < 45% by echocardiogram (6)Current severe heart diseases (7)History of myocardial infarction or unstable angina within 6 months of enrollment (8)Current severe, uncontrolled systemic diseases (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) (9)Patients who have untreated, symptomatic, or uncontrollable CNS metastases (10)Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (11)Current peripheral neuropathy of Grade >/= 3 per the Common Toxicity Criteria for Adverse Events (CTCAE) v. 4.0.3 (12)Patients who have had chemotherapy or radiotherapy within defined weeks prior to entering the study or those who have not recovered from adverse events due to agents administered early (13)Investigational therapy in another clinical study for therapeutic intent administered within 28 days before first study treatment (14)Major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment (15)Current known active infection with HIV, hepatitis B, or hepatitis C virus (16)History of other malignancy within the last 5 years (17)Patients who cannot be hospitalized for at least 8 days from day1 in the first cycle Details are documented in the original protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified