Patient case: 50-year-old female with Lung cancer. Genetic variant: EGFR (L858R). Other conditions: Lupus.

Clinical trial: A Study to Evaluate the Efficacy, and Safety of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Urothelial Bladder Cancer (UBC) or Pancreas/Cholangio Cancer (Kameleon Study)

Summary: This multicenter, non-randomized, Phase II, single agent study will assess the efficacy, and safety of trastuzumab emtansine in participants with HER2-positive (immunohistochemistry [IHC]3+ in greater than or equal to [>/=] 30 percent [%] of tumor cells) locally advanced or metastatic UBC or metastatic pancreas/cholangio cancer. Participants must have received at least one prior (for bladder cancer platinum-based) treatment for inoperable, locally advanced or metastatic tumor. Participants will receive intravenous (IV) infusion (infusion duration=90 minutes [mins]) of trastuzumab emtansine until unacceptable toxicity, withdrawal of consent, disease progression (PD), or death, whichever occurs first.


Eligibility: Inclusion Criteria:
  -  Histologically centrally confirmed HER2-positive (IHC3+ in >/=30% of tumor cells): locally advanced, metastatic (not treatable with curative intent) UBC or pancreas/cholangio cancer
  -  There must be no standard treatment options available for participants with the above HER2 overexpressing tumors and they must have undergone at least one prior platinum-based treatment for inoperable, locally advanced or metastatic tumor. (Note: for pancreas/cholangio cancer, prior treatments are NOT required to be platinum-based)
  -  Participant's lesion should be measurable according to RECIST V1.1 on diagnostic computed tomography (CT) scan/magnetic resonance imaging (MRI); Target lesion(s) should not have been previously irradiated
  -  At least one formalin-fixed paraffin-embedded (FFPE) biopsy of the primary tumor and/or from a metastatic site is required
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
  -  No significant cardiac history and a current left ventricular ejection fraction (LVEF) >/=50 percent (%)
  -  Adequate organ function
  -  Life expectancy of at least 12 weeks
  Exclusion Criteria:
  -  Participants with previous exposure to HER2-targeted therapies in any setting
  -  Participants showing histologically confirmed focal HER2-expression, i.e., less than (<) 30% of positively stained tumor cells
  -  Participants with bone only metastases are not eligible
  -  Participants with brain metastasis as the sole site of metastatic disease and/or are symptomatic or require therapy to control symptoms
  -  Current uncontrolled hypertension (systolic >150 millimeters of mercury [mmHg] and/or diastolic >100 mmHg)
  -  Current unstable angina pectoris
  -  History of symptomatic congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria or ventricular arrhythmia that requires treatment
  -  History of myocardial infarction within the last 6 months
  -  Peripheral neuropathy, Grade >/=3
  -  Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
  -  Current severe, uncontrolled systemic disease
  -  History of other malignancy within the last 5 years
  -  Concurrent, serious, uncontrolled infections or current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C
  -  Known prior severe hypersensitivity to trastuzumab and trastuzumab emtansine or the excipients of the investigational medicinal product (IMP)
  -  Clinically significant bleeding within 30 days before enrollment
  -  Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
  -  Concurrent participation in any other therapeutic clinical trial

Relevance to patient case: not relevant