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A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

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Trial Information

A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy


Inclusion Criteria:



- Adult patients, >/= 18 years of age

- Inoperable, locally advanced, recurrent or metastatic (Stage IIIB or IV) non-small
cell lung cancer (NSCLC)

- Presence of epidermal growth factor receptor (EGFR) mutations

- Previously untreated with any systemic anti-neoplastic therapy for advanced disease

- Last dose of a prior systemic anti-neoplastic therapy for early-stage disease >/= 4
weeks before study start, and patient recovered from acute toxicities of any previous
therapy

Exclusion Criteria:

- Pregnant or breast feeding women

- Known allergy or other adverse reaction to study drug or any other related compound

- Prior systemic anti-neoplastic therapy with HER1/EGFR inhibitors (as small molecule
or monoclonal antibody therapy)

- Newly diagnosed or not yet definitively treated (i.e. stable disease >/= 2 months)
CNS metastases or spinal cord compression

- Any significant ophthalmological abnormality, especially those likely to increase the
risk of corneal epithelial lesions (the use of contact lenses is not recommended
during the study)

- Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of
the skin that have been excised and cured

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival according to grade of rash; tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST criteria

Outcome Time Frame:

up to 3 years

Safety Issue:

Yes

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Israel: Minisrty of Health

Study ID:

ML25200

NCT ID:

NCT01174563

Start Date:

February 2011

Completion Date:

December 2014

Related Keywords:

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

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