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Efficacy and Safety of erLotinib (Tarceva® ) Therapy in patiEnts With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) , Subtype adEnocarcinoma, Who Have Good performaNce sTatus (PS 0-1) - ELEMENT


N/A
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

Efficacy and Safety of erLotinib (Tarceva® ) Therapy in patiEnts With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) , Subtype adEnocarcinoma, Who Have Good performaNce sTatus (PS 0-1) - ELEMENT


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Histologically or cytologically confirmed, locally advanced (Stage IIIb) or
metastatic (Stage IV) adenocarcinoma non-small cell lung cancer

- Eastern Cooperative Oncology Group (ECOG) performance status 0-1

- Adequate hematologic, renal and liver function

- Patient initiating treatment with Tarceva according to the Summary of Product
Characteristics

Exclusion Criteria:

- Any contraindications to treatment with Tarceva according to the Summary of Product
Characteristics and local label

- Any other malignancies within the previous 5 years, except for in situ carcinoma of
the cervix and basal and squamous cell carcinoma of the skin

- Previous systemic anti-cancer treatment with HER1/EGFR inhibitor

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Progression-free survival

Outcome Time Frame:

approximately 2.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Serbia: Agency for Medicines and Medical Devices of Serbia

Study ID:

ML28282

NCT ID:

NCT01836133

Start Date:

May 2013

Completion Date:

February 2015

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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