Clinical trial NCT01204697: A Study of Erlotinib [Tarceva] as Monotherapy or Intermittent Dosing With Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer. (TALISMAN)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-09-17
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of Participants Free From Disease Progression or Death at 6 Months
timeFrame: Month 6
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From randomization until progressive disease or death, assessed up to 18 months
measure: Overall Survival (OS)
timeFrame: From randomization until death, assessed up to 18 months
measure: Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR)
timeFrame: From randomization until progressive disease or death, assessed up to 18 months
measure: Percentage of Participants With Disease Control
timeFrame: From randomization until progressive disease or death, assessed up to 18 months
measure: Duration of Response (DoR)
timeFrame: From randomization until progressive disease or death, assessed up to 18 months
Other outcomes:
Locations:
city: Avellino
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Parma
country: Italy
state: Emilia-Romagna
city: Aviano (PN)
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Cremona
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Sondalo
country: Italy
state: Lombardia
city: Macerata
country: Italy
state: Marche
city: Lecce
country: Italy
state: Puglia
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Pontedera
country: Italy
state: Toscana
city: Treviso
country: Italy
state: Veneto
city: Vicenza
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: