Clinical trial NCT01609543: A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
Official title: Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-06-01
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
* Non-small cell lung cancer with an EGFR activating mutation
* Patients must have evidence of disease, but measurable disease is not mandatory
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Adequate renal and liver function

Exclusion Criteria:

* Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
* Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
* Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
* Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
* Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
* Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
* Pregnant or breast-feeding women

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline to progressive disease or death (up to 34 months)
Secondary outcomes:
measure: Percentage of Participants With Best Overall Response (BOR)
timeFrame: Baseline to progressive disease or death (up to 34 months)
measure: Percentage of Participants Who Were Alive at 1 Year
timeFrame: 1 Year (12 months)
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Deszk
country: Hungary
city: Farkasgyepu
country: Hungary
city: Gyula
country: Hungary
city: Mosonmagyaróvar
country: Hungary
city: Mátraháza
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Pecs
country: Hungary
city: Szekesfehervar
country: Hungary
city: Szekszard
country: Hungary
city: Szolnok
country: Hungary
city: Szombathely
country: Hungary
city: Torokbalint
country: Hungary
city: Törökbálint
country: Hungary
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Antalya
country: Turkey
city: Edirne
country: Turkey
city: Istanbul
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Markoczy Z, Sarosi V, Kudaba I, Galffy G, Turay UY, Demirkazik A, Purkalne G, Somfay A, Papai-Szekely Z, Raso E, Ostoros G. Erlotinib as single agent first line treatment in locally advanced or metastatic activating EGFR mutation-positive lung adenocarcinoma (CEETAC): an open-label, non-randomized, multicenter, phase IV clinical trial. BMC Cancer. 2018 May 25;18(1):598. doi: 10.1186/s12885-018-4283-z.