This open-label, single arm study will assess the correlation between Tarceva (erlotinib)-induced rash and efficacy in participants with inoperable, locally advanced, recurrent or metastatic non-small cell lung cancer (NSCLC) receiving first-line therapy for advanced disease. Participants 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, unacceptable toxicity, or withdrawal due to any reason.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol
Haemek Hospital; Oncology
Afula, Israel
Barzilai; Oncology
Ashkelon, Israel
Soroka Medical Center; Oncology Dept
Beersheba, Israel
Carmel Hospital; Oncology Unit
Haifa, Israel
Rambam Medical Center; Oncology
Haifa, Israel
Wolfson Hospital; Oncology
Holon, Israel
Shaare Zedek Medical Center; Oncology Dept
Jerusalem, Israel
Hadassah Ein Karem Hospital; Oncology Dept
Jerusalem, Israel
Meir Medical Center; Oncology
Kfar Saba, Israel
Nahariya Hospital; Oncology
Nahariya, Israel
...and 6 more locations
Progression-free Survival (PFS) According to Grade of Rash
PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Time frame: Day 1 of treatment period until disease progression or death (approximately up to 67 months)
Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4
Time frame: Day 1 of treatment period until disease progression or death (approximately up to 67 months)
Progression-Free Survival (PFS) in Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4
PFS was defined as the time from start of treatment to the date of the first documented progression according to revised Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1 or the date of death for any reason in the absence of progressive disease (PD). Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions compared to smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions, or presence of new lesions.
Time frame: Day 1 of treatment period until disease progression or death (approximately up to 67 months)
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