Status:
COMPLETED
Safety and Efficacy of Carboplatin/Paclitaxel and Carboplatin/Paclitaxel/Bevacizumab With and Without Pictilisib in Previously Untreated Advanced or Recurrent Non-small Cell Lung Cancer
Lead Sponsor:
Genentech, Inc.
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety of carboplatin/paclitaxel and carboplatin/paclitaxel/bevacizumab with and without pictilisib ...
Eligibility Criteria
Inclusion
- Histologically documented advanced (Stage IV) or recurrent squamous (Arms A and B) or non-squamous (Arms C, D, E, and F) non-small cell lung cancer (NSCLC)
- Consent to the collection of an archival formalin-fixed paraffin-embedded (FFPE) block or freshly cut unstained tumor slides from archival tumor tissue or a newly collected tumor sample
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Disease that is measurable per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- Adequate hematologic and end organ function
- Use of two effective forms of contraception
Exclusion
- NSCLC with documented epidermal growth factor receptor (EGFR) mutation associated with response to EGFR inhibitors or documented fusion gene involving anaplastic lymphoma kinase (ALK) gene
- 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
- Known central nervous system (CNS) disease except for treated brain metastases
- Type I diabetes
- Type II diabetes requiring chronic therapy with insulin
- 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 participant at high risk for treatment complications
- Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC (Arms C, D, E, and F)
Key Trial Info
Start Date :
January 20 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2016
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT01493843
Start Date
January 20 2012
End Date
March 30 2016
Last Update
April 25 2017
Active Locations (120)
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1
Alabama Oncology
Birmingham, Alabama, United States, 35211
2
Highlands Oncology Group
Rogers, Arkansas, United States, 72758
3
cCare
Encinitas, California, United States, 92024
4
Kaiser Permanente - Oakland
Oakland, California, United States, 94611