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

Completed · Phase 2 · Has a placebo group

Conditions studied: Non-Small Cell Lung Cancer

In brief

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 in particpants with previously untreated advanced or recurrent non-small cell lung cancer (NSCLC). Particpants will be randomized to receive 4 cycles of carboplatin (C)/paclitaxel (P) and either pictilisib or placebo, with (participants with non-squamous NSCLC) or without (participants with squamous NSCLC) bevacizumab (B). Anticipated time on study treatment is until disease progression or intolerable toxicity occurs. Participants in placebo arms with disease progression may cross over to open-label active pictilisib.

Key facts

Study ID

NCT01493843

Run by

Genentech, Inc.

People needed

501

Starts

2012-01-20

Expected to finish

2016-03-30

Last updated by the study team

2017-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Highlands Oncology Group — Rogers, Arkansas, United States
• cCare — Encinitas, California, United States
• Kaiser Permanente - Oakland — Oakland, California, United States
• Desert Hematology Oncology Group — Rancho Mirage, California, United States
• Kaiser Permanente - Roseville — Roseville, California, United States
• Kaiser Permanente Sacramento Medical Center — Sacramento, California, United States
• Southern CA Permanente Med Grp — San Diego, California, United States
• Kaiser Permanente — San Francisco, California, United States
• K. Permanente - Santa Clara — Santa Clara, California, United States
• Stockton Hema Onc Med Grp Inc — Stockton, California, United States
• Kaiser Permanente - Vallejo — Vallejo, California, United States
• K. Permanente - Walnut Creek — Walnut Creek, California, United States
• Hematology Oncology PC; Bennett Cancer Center — Stamford, Connecticut, United States
• Lynn Regional Cancer Center West — Boca Raton, Florida, United States
• Florida Cancer Specialists - Fort Myers (Colonial Center Dr) — Fort Myers, Florida, United States
• Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy) — Jacksonville, Florida, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Florida Cancer Specialists (St. Petersburg - St. Anthony's Professional Building) — St. Petersburg, Florida, United States
• University Cancer & Blood Center, LLC — Athens, Georgia, United States
• Peachtree Hematology & Oncology Consultants, Pc — Atlanta, Georgia, United States
• Georgia Cancer Specialists — Atlanta, Georgia, United States
• Hematology-Oncology of Indiana, Pc — Indianapolis, Indiana, United States
• Franklin Square Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital. — Boston, Massachusetts, United States
• Alabama Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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