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
Status: | Completed |
---|---|
Conditions: | Lung Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/3/2016 |
Start Date: | January 2012 |
End Date: | March 2016 |
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
This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the
efficacy and safety 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 (NSCLC). Patients will be randomized to receive 4 cycles of
carboplatin/paclitaxel and either GDC-0941 or placebo, with (patients with non-squamous
NSCLC) or without (patients with squamous NSCLC) bevacizumab. Anticipated time on study
treatment is until disease progression or intolerable toxicity occurs. Patients in placebo
arms with disease progression may cross over to open-label active GDC-0941.
efficacy and safety 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 (NSCLC). Patients will be randomized to receive 4 cycles of
carboplatin/paclitaxel and either GDC-0941 or placebo, with (patients with non-squamous
NSCLC) or without (patients with squamous NSCLC) bevacizumab. Anticipated time on study
treatment is until disease progression or intolerable toxicity occurs. Patients in placebo
arms with disease progression may cross over to open-label active GDC-0941.
Inclusion Criteria:
- 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
- ECOG performance status of 0 or 1
- Disease that is measurable per RECIST v1.1
- Adequate hematologic and end organ function
- Use of effective contraception
Exclusion Criteria:
- NSCLC with documented EGFR mutation associated with response to EGFR inhibitors or
documented fusion gene involving 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 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 patient at high risk for treatment
complications
- Medical conditions that would contraindicate bevacizumab therapy in non-squamous
NSCLC
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