A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor (HER)2 Immunohistochemistry (IHC)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/9/2019 |
Start Date: | December 15, 2014 |
End Date: | August 20, 2018 |
A Phase 2, Multicenter, Single-Arm Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Received At Least One Prior Chemotherapy Regimen
This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of
trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2
IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with
trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram
(mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the
investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs
first.
trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2
IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with
trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram
(mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the
investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs
first.
Inclusion Criteria:
- Histologically or cytologically documented diagnosis of Stage IIIB not amenable to
radical treatment or Stage IV NSCLC (pathological characterization must determine the
non-squamous or squamous histological subtype as well as adenocarcinoma subtype
classification)
- HER2 status of IHC 2+ or 3+ as determined by a Sponsor-designated central laboratory
- Prior treatment with at least one regimen of platinum-based (cisplatin or carboplatin)
chemotherapy in the locally advanced or metastatic setting/recurrent NSCLC with
documented disease progression by investigator assessment
- Participants with a known anaplastic lymphoma kinase (ALK) fusion oncogene (must be
documented in the participant's chart) must have also experienced disease progression
or intolerance with a first-line ALK Tyrosine Kinase Inhibitor (TKI) approved for the
treatment of ALK fusion oncogene NSCLC (for example, crizotinib). Disease progression
or intolerance must be documented
- Participants with a known mutation in the epidermal growth factor receptor (EGFR) gene
(must be documented in the participant's chart) must have also experienced disease
progression or intolerance with an EGFR TKI approved for the treatment of EGFR-mutant
NSCLC (for example, gefitinib, erlotinib, afatinib). Disease progression or
intolerance must be documented
- Measurable disease determined as per the RECIST v1.1
- Life expectancy of at least (>/=) 12 weeks
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) >/= 50 percent (%) by either echocardiogram
(ECHO) or multiple-gated acquisition (MUGA) scan
- Use of highly effective contraception
Exclusion Criteria:
Cancer-Related Criteria:
- Any approved anti-cancer therapy less than or equal to (=) 21 days (including
chemotherapy or hormonal therapy) before the first study treatment; the following
exceptions are allowed: (1) TKIs approved for the treatment of NSCLC must be
discontinued greater than (>) 7 days prior to the first study treatment on D1C1 (The
baseline computed tomography [CT] scan must be completed after discontinuation of
TKIs); (2) Hormone-replacement therapy or oral contraceptives; (3) Anti-emetics,
Granulocyte-colony stimulating factor (GCS-F), and prophylactic antibiotics according
to local standards
- Investigational therapy participation in another clinical study with therapeutic
intent = 21 days before first study treatment
- Previous irradiation is permitted if >/=14 days since the last fraction of
radiotherapy have elapsed before the first study treatment on Day 1 as long as a
sufficient number of target lesions remain to allow for measurable disease as per
RECIST v1.1
- Participants who have untreated brain metastases or are symptomatic; participants with
treated brain metastases must have discontinued corticosteroid therapy and not have
any neurological symptoms
- History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity
to trastuzumab or murine proteins or any excipient of the product
- History of exposure to the following cumulative doses of anthracyclines: Doxorubicin
or liposomal doxorubicin > 500 milligram per meter-square (mg/m^2); Epirubicin > 900
mg/m^2; Mitoxantrone > 120 mg/m^2. If another anthracycline, or more than one
anthracycline, has been used, the cumulative dose must not exceed the equivalent of
500 mg/m^2 doxorubicin
- Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute Common Toxicity
Criteria for Adverse Events Version 4.0 (NCI CTCAE v. 4.0)
- History of other malignancy within the last 5 years, except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer,
or other cancers with a similar outcome as those mentioned above
Cardiopulmonary Function Criteria:
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent
drainage procedures
- Severe dyspnea at rest due to complications of advanced malignancy or requiring
current continuous oxygen therapy
- Clinical history of active hemoptysis
- Evidence of active pneumonitis during screening
- Current unstable ventricular arrhythmia requiring treatment
- History of symptomatic congestive heart failure (CHF) New York Heart Association
(NYHA) classes II-IV
- History of myocardial infarction or unstable angina within 6 months of enrollment
- History of a decrease in LVEF to <50%
General Criteria:
- Current severe, uncontrolled systemic disease (for example, clinically significant
cardiovascular, pulmonary, or metabolic disease)
- 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
- Current pregnancy or lactation
- Current known active infection with human immunodeficiency virus (HIV), hepatitis B
virus (HBV), or hepatitis C virus (HCV)
We found this trial at
6
sites
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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11 Walterhöferstraße
Berlin, 14165
Berlin, 14165
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7015 A C Skinner Parkway
Jacksonville, Florida 32256
Jacksonville, Florida 32256
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