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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01328951
First received: April 4, 2011
Last updated: July 14, 2014
Last verified: July 2014

April 4, 2011
July 14, 2014
September 2011
March 2016   (final data collection date for primary outcome measure)
Overall survival (OS): First-line maintenance Tarceva versus Tarceva at time of disease progression [ Time Frame: 42 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01328951 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
  • Drug: erlotinib [Tarceva]
    150 mg orally daily, first-line maintenance until disease progression
  • Drug: Placebo
    orally daily, first-line maintenance until disease progression
  • Drug: erlotinib [Tarceva]
    150 mg orally daily, second-line after disease progression on placebo, until disease progression
  • Experimental: A first line maintenance
    Intervention: Drug: erlotinib [Tarceva]
  • Placebo Comparator: B placebo
    Intervention: Drug: Placebo
  • Experimental: C second line
    Intervention: Drug: erlotinib [Tarceva]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
643
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Bulgaria,   Canada,   China,   Czech Republic,   France,   Hungary,   Italy,   Korea, Republic of,   Latvia,   Lithuania,   Netherlands,   Poland,   Romania,   Slovakia,   South Africa,   Taiwan,   Thailand,   Ukraine
 
NCT01328951
BO25460
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP