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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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: April 4, 2011
Last updated: November 24, 2014
Last verified: November 2014

This double-blind, placebo-controlled study will evaluate the benefit of first-l ine maintenance Tarceva (erlotinib) versus Tarceva at the time of disease progre ssion in patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following 4 cycles of platinum based-chemotherapy and whose tumour do es not harbor an EGFR activating mutation. Patients will be randomized to receiv e either Tarceva 150 mg orally daily or placebo until disease progression or una cceptable toxicity occurs. Patients who progressed on placebo will receive Tarce va 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: Placebo
Drug: erlotinib [Tarceva]
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:

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 ]

Enrollment: 643
Study Start Date: September 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 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


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01328951

  Show 154 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01328951     History of Changes
Other Study ID Numbers: BO25460
Study First Received: April 4, 2011
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Disease Progression
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Disease Attributes
Lung Diseases
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors processed this record on November 24, 2014