A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
A Randomized Phase II Trial of Erlotinib or Intermittent Dosing of Erlotinib and Docetaxel in Male Former-smokers With Locally Advanced or Metastatic Squamous NSCLC in Second-line Setting After Failure on Chemotherapy
1 other identifier
interventional
74
1 country
20
Brief Summary
This randomized parallel group study will assess the efficacy and safety of erlotinib \[Tarceva\], as monotherapy or intermittent dosing with docetaxel, in second-line setting in former-smoker male patients with advanced or metastatic squamous non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg/day orally) as monotherapy or 4 cycles of docetaxel (75 mg/m2 intravenously every 3 weeks) plus Tarceva (150 mg/day orally, days 2-16 each cycle) followed by Tarceva monotherapy. Anticipated time on study treatment is until disease progression.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2010
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2010
CompletedFirst Posted
Study publicly available on registry
September 17, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
November 16, 2015
CompletedNovember 16, 2015
October 1, 2015
3.7 years
September 16, 2010
October 15, 2015
October 15, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Free From Disease Progression or Death at 6 Months
According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, progressive Disease (PD) is defined as: for Target Lesions - At least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). (Note: the appearance of one or more new lesions is also considered progression). For Non-Target Lesions - Unequivocal progression of existing non-target lesions. (Note: the appearance of one or more new lesions is also considered progression).
Month 6
Secondary Outcomes (5)
Progression-free Survival (PFS)
From randomization until progressive disease or death, assessed up to 18 months
Overall Survival (OS)
From randomization until death, assessed up to 18 months
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)
From randomization until progressive disease or death, assessed up to 18 months
Percentage of Participants With Disease Control
From randomization until progressive disease or death, assessed up to 18 months
Duration of Response (DoR)
From randomization until progressive disease or death, assessed up to 18 months
Study Arms (2)
A
EXPERIMENTALB
EXPERIMENTALInterventions
150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
Eligibility Criteria
You may qualify if:
- male patients, \>/=18 years of age
- former smoker (smoked \>/= 100 cigarettes in his lifetime and quit \>12 months before enrollment)
- locally advanced (stage IIIb), metastatic (stage IV) or recurrent squamous non-small cell lung cancer
- prior platinum-based therapy for advanced NSCLC
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
You may not qualify if:
- uncontrolled symptomatic central nervous system (CNS) metastases
- prior therapy against epidermal growth factor receptor (EGFR)
- \>1 prior chemotherapy for advanced/metastatic NSCLC
- radiotherapy \<28 days prior to enrollment
- history of melanoma at any time, or another malignancy in the last 5 years except for carcinoma in situ of the cervix, basal or squamous cell carcinoma of the skin, or surgically cured malignant neoplasias with a disease-free interval of \>5 years
- not fully treated eye inflammation or infection, or predisposing conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Unknown Facility
Lecce, Apulia, 73100, Italy
Unknown Facility
San Giovanni Rotondo, Apulia, 71013, Italy
Unknown Facility
Avellino, Campania, 83100, Italy
Unknown Facility
Napoli, Campania, 80131, Italy
Unknown Facility
Parma, Emilia-Romagna, 43100, Italy
Unknown Facility
Aviano (PN), Friuli Venezia Giulia, 33081, Italy
Unknown Facility
Rome, Lazio, 00152, Italy
Unknown Facility
Rome, Lazio, 00157, Italy
Unknown Facility
Rome, Lazio, 00168, Italy
Unknown Facility
Cremona, Lombardy, 26100, Italy
Unknown Facility
Milan, Lombardy, 20142, Italy
Unknown Facility
Monza, Lombardy, 20900, Italy
Unknown Facility
Pavia, Lombardy, 27100, Italy
Unknown Facility
Sondalo, Lombardy, 23039, Italy
Unknown Facility
Macerata, The Marches, 62100, Italy
Unknown Facility
Lido di Camaiore, Tuscany, 55043, Italy
Unknown Facility
Pisa, Tuscany, 56124, Italy
Unknown Facility
Pontedera, Tuscany, 56025, Italy
Unknown Facility
Treviso, Veneto, 31100, Italy
Unknown Facility
Vicenza, Veneto, 36100, Italy
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2010
First Posted
September 17, 2010
Study Start
November 1, 2010
Primary Completion
July 1, 2014
Study Completion
July 1, 2014
Last Updated
November 16, 2015
Results First Posted
November 16, 2015
Record last verified: 2015-10