A Study on the Correlation Between Tarceva (Erlotinib) - Induced Rash and Efficacy in EGFR Mutated Patients With Advanced Non-Small Cell Lung Cancer Receiving First-Line Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01174563
Recruitment Status : Completed
First Posted : August 3, 2010
Last Update Posted : June 1, 2017
Clalit Health Services
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in patients with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Patients will receive Tarceva at a dose of 150 mg daily orally, with dose adjustments according to protocol depending on toxicity. Anticipated time on study treatment is until disease progression occurs.

Condition or disease Intervention/treatment Phase
Non-Squamous Non-Small Cell Lung Cancer Drug: erlotinib [Tarceva] Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Center Study Investigating the Correlation Between TARCEVA ®-Induced Rash and Efficacy Among EGFR-mutated NSCLC Patients Receiving First-line Therapy
Actual Study Start Date : May 31, 2011
Actual Primary Completion Date : December 20, 2016
Actual Study Completion Date : December 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer Rashes

Arm Intervention/treatment
Experimental: Single Arm Drug: erlotinib [Tarceva]
150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

Primary Outcome Measures :
  1. Progression-free survival according to grade of rash; tumor assessments by computer tomography (CT) or magnetic resonance imaging (MRI) according to RECIST criteria [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Rate of Tarceva dose reductions due to grade III-IV rash [ Time Frame: approximately 3 years ]
  2. Progression-free survival in patients with Tarceva dose reductions due to grade III-IV rash; tumor assessments by CT or MRI according to RECIST criteria [ Time Frame: up to 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01174563

Haemek Hospital; Oncology
Afula, Israel, 18101
Barzilai; Oncology
Ashkelon, Israel, 78278
Soroka Medical Center; Oncology Dept
Beer Sheva, Israel, 8410101
Carmel Hospital; Oncology Unit
Haifa, Israel, 34362
Rambam Medical Center; Oncology
Haifa, Israel, 4959381
Wolfson Hospital; Oncology
Holon, Israel, 58100
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, Israel, 91031
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel, 91120-01
Meir Medical Center; Oncology
Kfar-Saba, Israel, 4428164
Nahariya Hospital; Oncology
Nahariya, Israel, 22100
Chaim Sheba Medical Center; Oncology Dept
Ramat Gan, Israel, 5262100
Kaplan Medical Center; Oncology Inst.
Rehovot, Israel, 7610001
Ziv Medical Center; Oncology Department
Sefad, Israel, 13100
Sourasky / Ichilov Hospital; Oncology Department
Tel Aviv, Israel, 64239-06
Poria Hospital; Oncology
Tiberias, Israel, 15208
Assaf Harofeh; Oncology
Zerifin, Israel, 6093000
Sponsors and Collaborators
Hoffmann-La Roche
Clalit Health Services
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01174563     History of Changes
Other Study ID Numbers: ML25200
First Posted: August 3, 2010    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action