A Study of First-line Maintenance Tarceva (Erlotinib) Versus Tarceva at Time of Disease Progression in Patients With Advanced Non-small Cell Lung Cancer After Chemotherapy - Full Text View

Purpose

This double-blind, placebo-controlled study will evaluate the benefit of first-line maintenance Tarceva (erlotinib) versus Tarceva at the time of disease progression in patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumour does not harbor an EGFR activating mutation. Patients will be randomized to receive either Tarceva 150 mg orally daily or placebo until disease progression or unacceptable toxicity occurs. Patients who progressed on placebo will receive Tarceva 150 mg orally daily in second line until disease progression or unacceptable toxicity. Anticipated time on study treatment is up to 42 months.

Condition	Intervention	Phase
Non-Small Cell Lung Cancer	Drug: erlotinib [Tarceva] Drug: Placebo	Phase 3

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 Randomized, Double-blind, Placebo-controlled Phase 3 Study of First-line Maintenance Tarceva vs Tarceva at the Time of Disease Progression in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Have Not Progressed Following 4 Cycles of Platinum-based Chemotherapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Overall survival (OS): First-line maintenance Tarceva versus Tarceva at time of disease progression [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression-free survival (PFS): First-line maintenance Tarceva versus placebo (tumour assessments according to RECIST criteria) [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Overall response rate (ORR): First-line maintenance Tarceva versus placebo [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Disease control rate (DCR): First-line maintenance Tarceva versus placebo [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	610
Study Start Date:	September 2011
Estimated Study Completion Date:	June 2016
Estimated Primary Completion Date:	June 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A first line maintenance	Drug: erlotinib [Tarceva] 150 mg orally daily, first-line maintenance until disease progression
Placebo Comparator: B placebo	Drug: Placebo orally daily, first-line maintenance until disease progression
Experimental: C second line	Drug: erlotinib [Tarceva] 150 mg orally daily, second-line after disease progression on placebo, until disease progression

Eligibility

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

Criteria

Inclusion Criteria:

Adult patients, >/= 18 years of age (or >/= legal age of consent if greater than 18)
Advanced or recurrent (Stage IIIb) or metastatic (Stage IV) non-small cell lung cancer (NSCLC)
Completion of 4 cycles of platinum-based chemotherapy without progression (end of last chemotherapy cycle </= 28 days prior to randomization)
ECOG performance status 0-1

Exclusion Criteria:

Prior exposure to agents directed at HER axis (e.g. erlotinib, gafitinib, cetuximab)
Patients whose tumours harbour an EGFR activating mutation
Prior chemotherapy or therapy with systemic anti-neoplastic therapy for advanced disease before screening (platinum-based chemotherapy)
Use of pemetrexed in maintenance setting (pemetrexed is allowed during the chemotherapy run-in)
Patients who have undergone complete tumour resection after responding to the platinum-based chemotherapy during the screening phase
Any other malignancies within 5 years, except for curatively resected carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ or organ confined prostate cancer
CNS metastases or spinal cord compression that has not been definitely treated with surgery and/or radiation, or treated CNS metastases or spinal cord compression without stable disease for >/= 2 months
HIV, hepatitis B or hepatitis C infection
Any inflammatory changes of the surface of the eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328951

Contacts

Contact: Please reference Study ID Number: BO25460 www.roche.com/about_roche/roche_worldwide.htm

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

genentechclinicaltrials@druginfo.com

Show 156 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01328951 History of Changes
Other Study ID Numbers:	BO25460
Study First Received:	April 4, 2011
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Disease Progression
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms

Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013