A PHASE II, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF CARBOPLATIN/PACLITAXEL AND CARBOPLATIN/PACLITAXEL/BEVACIZUMAB WITH AND WITHOUT GDC-0941 IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED OR RECURRENT NON-SMALL CELL LUNG CANCER.
- Conditions
- Previously untreated advanced or recurrent non-small cell lung cancer10038666
- Registration Number
- NL-OMON39705
- Lead Sponsor
- Genentech Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
For ALL Arms:
• All patients must consent to the collection of an archival formalin-fixed paraffin embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue (10-15 preferred, minimum of 5 slides required) or a newly collected tumor sample for PIK3CA amplification testing and/or PTEN IHC, as well as for other protocol-mandated exploratory assessments.
• Age >= 18 years
• ECOG performance status of 0 or 1
• Disease that is measurable per RECIST v1.1
• Adequate hematologic and end organ function, defined by specific laboratory results obtained within 14 days prior to the first study treatment.;For Arms A and B:
• Histologically documented advanced (Stage IV) or recurrent squamous NSCLC;For Arms C, D, E & F:
• Histologically documented advanced (Stage IV) or recurrent non-squamous NSCLC
For ALL Arms:
• NSCLC with documented EGFR mutation assosciated with response to EGFR inhibitors or documented fusion gene involving the anaplastic lymphoma kinase (ALK) gene (such as EML4-ALK)
• 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 advanced (Stage IV) or recurrent NSCLC
• Evidence of tumor invading major blood vessels on imaging
• Known CNS disease except for treated brain metastases
• Leptomeningeal disease
• Malignancies other than NSCLC successfully treated within 3 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 and carcinoma in situ of any anatomic location treated with curative intent
• Type I diabetes
• Type II diabetes requiring chronic therapy with insulin
• Requirement for supplemental oxygen therapy to perform activities of daily living
• Unstable angina
• Serious cardiac arrhythmia requiring medication during the study
• New York Heart Association (NYHA) Class II or greater congestive heart failure
• History of malabsorption syndrome or other condition that would interfere with enteral absorption
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study
• Clinically significant history of liver disease, including cirrhosis, active viral hepatitis and current alcohol abuse
• Known HIV infection
• Active infection requiring IV antibiotics
• Active inflammatory diseases that require immunosuppressants, including small or
large intestine inflammation such as Crohn*s disease or ulcerative colitis.
• Patients currently receiving immunosuppressants (e.g. sulfasalazines) are considered to have disease and are therefore ineligible
• Active autoimmune disease that is not controlled by nonsteroidal anti inflammatory drugs
• Need for current chronic corticosteroid therapy (>=10 mg of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids)
• Uncontrolled hypercalcemia, defined as values above the ULN, despite optimal management including bisphosphonate therapy
• Uncontrolled hypomagnesemia or hypokalemia, defined as values below the LLN despite optimal electrolyte supplementation or management
• Grade >= 2 peripheral neuropathy;Bevacizumab-Specific Exclusion Criteria for Arms C, D E and F:
• Histologically or cytologically documented, advanced, mixed non*small cell and small cell tumors or mixed adenosquamous carcinomas with a predominant squamous component
• Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• History of myocardial infarction within 6 months prior to Day 1 of Cycle 1
• History of stroke or transient ischemic attacks (TIAs) within 6 months prior to Day 1 of Cycle 1
• Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1 of Cycle 1
• History of hemoptysis defined as bright red
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Efficacy Outcome Measure<br /><br><br /><br>For ALL Arms and all predefined study populations (see Section 3.3.5), the<br /><br>primary efficacy outcome measure is:<br /><br>• PFS, defined as the time from randomization to disease progression as<br /><br>assessed by the investigator per RECIST v1.1 or death from any cause on study<br /><br>(<= 30 days after the last dose of study treatment) whichever occurs first</p><br>
- Secondary Outcome Measures
Name Time Method