HER2-positive, recurrent, non-small cell lung cancer (NSCLC)
Conditions
Interventions
Drug: trastuzumab emtansine 3.6 mg/kg trastuzumab emtansine will be given intravenously on Day 1 of each 21-day cycle. Treatment may continue until disease progression, unacceptable adverse events
s wish.
Sponsors
Okayama University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Written informed consent (2) Age >= 20 years (3) Pathologically documented diagnosis of NSCLC (4) Tumor HER2 status of IHC 3+, IHC 2+ and FISH-positive, or insertion mutation in the exon 20 (5) Stage IIIB/IV not amenable to curative local treatment or postsurgical recurrent NSCLC (6) Prior treatment with at least one regimen of platinum-based chemotherapy in the locally advanced or metastatic setting/recurrent NSCLC with documented disease progression by investigator assessment (History of resistance to the standard monotherapy is also accepted in patients aged 75 or older.) (7) Patients with a known mutation in the EGFR gene must have also experienced disease progression or intolerance with an EGFR-tyrosine Kinase Inhibitor (TKI). (8) Patients with a known ALK fusion oncogene must have also experienced disease progression or intolerance with an ALK-TKI. (9) Measurable disease determined as per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 (10) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 (11) Adequate organ function (12) No prior use of T-DM1 Details are documented in the original protocol.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Safety, time to response, disease control rate, progression-free survival, overall survival, and patient's reported outcome with CareNote Explanatory analysis: biomarker analysis for investigating any potential markers related to resistance to T-DM1 using tumor specimens and blood samples | — |
Countries
Japan
Contacts
Public ContactKatsuyuki Hotta
Okayama University Hospital Center for Innovative Clinical Medicine
Outcome results
None listed