ADVANCED OR RECURRENT NON-SQUAMOUS NON-SMALL CELL LUNG CANCER WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR ADVANCED DISEASE MedDRA version: 14.0 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.0 Level: LLT Classification code 10025052 Term: Lung cancer non-small cell stage III System Organ Class: 10029104 - Neoplasms benign, malignant and uns
Conditions
Interventions
Product Name: MEGF0444A
Product Code: MEGF0444A
Pharmaceutical Form: Solution for injection/concentrate for solution for infusion
Current Sponsor code: MEGF0444A
Other descriptive name: Anti-EGFL7, aE
Sponsors
Genentech, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria to be eligible for study entry: • Signed informed consent form • Age = 18 years • Able to comply with the protocol • Histologically or cytologically documented inoperable (Stage IV) or recurrent non-squamous NSCLC. Diagnoses of non-squamous NSCLC that are based on sputum cytology alone are not acceptable. Mixed tumors should be categorized according to the predominant cell type. • ECOG performance status of 0 or 1 (see Appendix E) • Life expectancy >12 weeks • Measurable disease, as defined by RECIST 1.1 (see Appendix C) • Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: Absolute neutrophil count (ANC) = 1500 cells/µL (without granulocyte colony-stimulating factor support within 2 weeks prior to randomization) Platelet count = 100,000/µL (without transfusion within 2 weeks prior to randomization) Hemoglobin = 9.0 g/dL Patients may be transfused or receive erythropoietic treatment to meet this criterion. AST, ALT, and alkaline phosphatase = 2.5 × ULN, with the following exceptions: Patients with documented liver metastases: AST and/or ALT = 5 × ULN Patients with documented liver or bone metastases:alkaline phosphatase = 5 × ULN, Serum bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: a. General Medical Exclusions • Prior therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy or investigational therapy) before Day 1 of Cycle 1 for the treatment of Stage IV or recurrent NSCLC Patients who received prior adjuvant chemotherapy or radiotherapy for NSCLC are not excluded if the time interval from completion of adjuvant therapy until disease progression is > 12 months. Patients who received prior palliative radiotherapy for bone metastases are not excluded (if >1 week prior to Day 1 of Cycle 1). Patients who receive hormone-replacement therapy or oral contraceptives are not excluded Patients who received herbal therapy = 2 weeks prior to Day 1 are not excluded • Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment • Malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent • Symptomatic or uncontrolled hypercalcemia requiring continued use of bisphosphonate therapy Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinical significant hypercalcemia are eligible. Uncontrolled hypercalcemia (Ca > 12 mg/dL or >1.5 ionized calcium) • Pregnant and lactating women • Known hypersensitivity to Chinese hamster ovary cell products, recombinant human antibodies or any of the chemotherapy agents to be used in this study • Any disorder that compromises the ability of the patient to provide written informed consent and/or to comply with study procedures • Leptomeningeal disease • Active infection requiring IV antibiotics • Active autoimmune disease that is not controlled by nonsteroidal anti-inflammatory drugs, inhaled corticosteroids, or the equivalent of = 10 mg/day prednisone • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, or cirrhosis • Grade = 2 peripheral neuropathy • 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 patient at high risk for treatment complications For Bevacizumab-Specific Exclusions please see study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of MEGF0444A used in combination with carboplatin + paclitaxel + bevacizumab therapy in patients with advanced or recurrent non-squamous NSCLC, as measured by progression-free survival;Secondary Objective: To evaluate the safety and tolerability of MEGF0444A in combination with paclitaxel + carboplatin + bevacizumab therapy in patients with advanced or recurrent non-squamous NSCLC • To evaluate the efficacy of MEGF0444A in combination with paclitaxel + carboplatin + bevacizumab therapy in patients with advanced or recurrent non-squamous NSCLC, as measured by objective response rate, duration of objective response and overall survival • To characterize the PK of MEGF0444A, and the PK of bevacizumab, carboplatin, and paclitaxel and its major metabolite (6a-hydroxypaclitaxel) when combined with MEGF0444A • To compare the delay in deterioration of disease-related symptoms, to show impact of MEGF0444A on global health status/Quality of Life and to evaluate treatment-related symptoms as measured by the European Organization for the Research and Treatment of Cancer, Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and the lung module (QLQ-LC13);Primary end point(s): The primary efficacy endpoint of this study is Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: Patients will undergo tumor assessment at baseline, after every 2 cycles and at treatment completion/early termination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy Endpoints Overall Response (OR) and Overall Survival (OS) ;Timepoint(s) of evaluation of this end point: For Overall Response (OR) Patients will undergo tumor assessment at baseline, after every 2 cycles and at treatment completion/early termination For Overall Survival (OS) Survival follow-up information will be collected via telephone calls, patient medical records, and/or clinic visits approximately every 3 months until death, loss to follow-up, or study termination by Genentech. | — |
Countries
Australia, Czech Republic, France, Germany, Hungary, Poland, United States
Contacts
Public ContactKP Smith
Genentech, Inc.
Outcome results
None listed