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 - Full Text View

Purpose

This multicenter, randomized, double-blind, placebo-controlled trial will evaluate the efficacy and safety 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.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: GDC-0941 Drug: carboplatin Drug: paclitaxel Drug: bevacizumab Drug: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Paclitaxel Carboplatin Bevacizumab

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Progression-free survival (PFS), defined as the time from randomization to disease progression as assessed by the investigator per RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective tumor response as assessed by the investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
Duration of objective response, defined as the time from first observation of an objective tumor response until first observation of disease progression as assessed by the investigator using RECIST v1.1 [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
Overall survival (OS), defined as the time from randomization until death from any cause [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: up to approximately 26 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	392
Study Start Date:	January 2012
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A GDC-0941 + carboplatin + paclitaxel	Drug: GDC-0941 Repeating oral dose Drug: carboplatin Intravenous repeating dose Drug: paclitaxel Intravenous repeating dose
Active Comparator: B Placebo + carboplatin + paclitaxel	Drug: carboplatin Intravenous repeating dose Drug: paclitaxel Intravenous repeating dose Drug: Placebo Repeating oral dose
Experimental: C/E GDC-0941 + carboplatin + paclitaxel + bevacizumab	Drug: GDC-0941 Repeating oral dose Drug: carboplatin Intravenous repeating dose Drug: paclitaxel Intravenous repeating dose Drug: bevacizumab Intravenous repeating dose
Active Comparator: D/F Placebo + carboplatin + paclitaxel + bevacizumab	Drug: Placebo Repeating oral dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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
Medical conditions that would contraindicate bevacizumab therapy in non-squamous NSCLC

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01493843

Contacts

Contact: Please reference Study ID Number: GO27912 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 118 Study Locations

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01493843 History of Changes
Other Study ID Numbers:	GO27912
Study First Received:	December 14, 2011
Last Updated:	February 20, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Bevacizumab
Carboplatin
Paclitaxel

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013