Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pertuzumab
Intervention description: Pertuzumab was supplied as a single-use liquid formulation.
Intervention MeSH terms: Pertuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Lung cancer

Summary:

      The purpose of this study is to determine if the study drug pertuzumab is effective in
      treating patients with advanced lung cancer that has recurred following prior chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  Tumor accessible to biopsy and willingness to undergo tumor biopsy

          -  Age >= 18 years

          -  Recurrent, histologically documented NSCLC, i.e., squamous cell, adeno-, or large cell
             anaplastic carcinoma. A cytologic diagnosis is acceptable (i.e. fine-needle aspiration
             or pleural fluid cytology).

          -  Measurable disease with at least one lesion that can be accurately measured in at
             least one dimension (bilateral dimensions should be recorded). Each lesion must be >=
             20 mm when measured by conventional techniques, including palpation, plain X-ray, CT,
             and MRI, or >= 10 mm when measured by spiral CT.

          -  Progression of disease during, or after completion of, at least one prior chemotherapy
             regimen, which should have contained either a platinum, a taxane or a vinca alkaloid
             (e.g. vinorelbine). There is no upper limit on the number of prior chemotherapy
             regimens each subject may have received.

          -  Recovery from reversible acute effects of prior chemotherapy regimens or radiotherapy
             to NCI-CTC Grade <= 1 (excluding alopecia)

          -  ECOG performance status of 0 or 1

          -  Use of an effective means of contraception for men, or for women of childbearing
             potential

          -  Absolute neutrophil count >= 1500/mL, platelet count of >= 75,000/mL and hemoglobin >=
             9 g/dL (hemoglobin may be supported by transfusion or erythropoietin or other approved
             hematopoietic growth factors; darbepoetin [Aranesp] is permitted)

          -  Serum bilirubin <= 1.5 x the upper limit of normal (ULN) and alkaline phosphatase,
             AST, and ALT <= 2.5 x ULN (ALT, AST, and alkaline phosphatase <= 5 x ULN for subjects
             with liver metastases)

          -  Serum creatinine <= 1.5 x ULN

          -  Internalized normalized ratio (INR) < 1.5 and activated partial thromboplastin time
             (aPTT) < 1.5 ULN (except for subjects receiving warfarin)

        Exclusion Criteria:

          -  Prior treatment with any HER pathway inhibitors (e.g., Herceptin [Trastuzumab], Iressa
             [gefitinib], Tarceva [erlotinib hydrochloride], C225, CI1033, TAK165

          -  Treatment with other experimental anti-cancer agents within 4 weeks prior to Day 1

          -  Histologically documented bronchioalveolar carcinoma

          -  History or clinical or radiographic evidence of central nervous system or brain
             metastases

          -  Ejection fraction, determined by ECHO, <50%

          -  Uncontrolled hypercalcemia (> 11.5 mg/dL)

          -  Prior exposure of > 360 mg/m2 doxorubicin or liposomal doxorubicin, > 120 mg/m2
             mitoxantrone, or > 90 mg/m2 idarubicin

          -  Ongoing corticosteroid treatment, except for subjects who are on stable doses of < 20
             mg of prednisone daily (or equivalent), or for subjects who are taking corticosteroids
             for non-malignant conditions

          -  History of other malignancies within 5 years of Day 1 except for adequately treated
             carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, or basal or
             squamous cell skin cancer

          -  History of serious systemic disease, uncontrolled hypertension (diastolic blood
             pressure > 100 mmHg on two consecutive occasions), unstable angina, congestive heart
             failure, or myocardial infarction within 6 months prior to Day 1, or unstable
             symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia,
             i.e., atrial fibrillation, paroxysmal supraventricular tachycardia, or controlled
             hypertension are eligible)

          -  Ongoing liver disease, including viral or other hepatitis, current alcohol abuse, or
             cirrhosis

          -  Active infection requiring IV antibiotics

          -  Known human immunodeficiency virus infection

          -  Pregnancy or lactation

          -  Major surgery or significant traumatic injury within 3 weeks prior to Day 1, with the
             exception of tumor biopsy for the purposes of the study

          -  Inability to comply with study and follow-up procedures

          -  Any other diseases, metabolic dysfunction, physical examination finding, or clinical
             laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that may affect the
             interpretation of the results or render the subject at high risk from treatment
             complications