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

Phase 2

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Adult participants, >/= 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
A life expectancy of at least 12 weeks
Able to comply with the study and its follow-up procedures
Female participants had to be postmenopausal (24 months of amenorrhea), surgically sterile or agree to use a physical method of contraception. Male participants had to be surgically sterile or agree to use a barrier method of contraception. Women with an intact uterus (unless amenorrhoeic for the last 24 months) had to have a negative pregnancy test (urine or serum) within 3 days prior to erlotinib treatment initiation in the study. Male and female participants had to use effective contraception during the study and for a period of 90 days following the last administration of erlotinib. Acceptable methods of contraception included an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms)

Exclusion Criteria

Pregnant or breast feeding women
Granulocyte count <1.5 x 109/L and platelet count <100*10^9/L
Serum bilirubin >1.5 upper limit of normal (ULN)
Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 2 * ULN (or >5 * ULN if clearly attributable to liver metastasis)
Serum creatinine >1.5 ULN or creatinine clearance <60 mL/min
Known allergy or other adverse reaction to study drug or any other related compound
Any significant unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease)
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)
Participants who could not take oral medication, who required intravenous alimentation, had had prior surgical procedures affecting absorption, or had active peptic ulcer disease
Active cancer other than NSCLC, except for basal cell or squamous cell carcinomas of the skin that have been excised and cured

Arm && Interventions

Group	Intervention	Description
Single Arm	erlotinib [Tarceva]	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) According to Grade of Rash	Day 1 of treatment period until disease progression or death (approximately up to 67 months)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Erlotinib Dose Reductions Due to Rash Grade 3-4	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	Day 1 of treatment period until disease progression or death (approximately up to 67 months)	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.

Locations (16): Haemek Hospital; Oncology
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Afula, Israel
Barzilai; Oncology
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Ashkelon, Israel
Meir Medical Center; Oncology
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Kfar-Saba, Israel
Hadassah Ein Karem Hospital; Oncology Dept
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Jerusalem, Israel
Rambam Medical Center; Oncology
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Haifa, Israel
Wolfson Hospital; Oncology
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Holon, Israel
Shaare Zedek Medical Center; Oncology Dept
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Jerusalem, Israel
Poria Hospital; Oncology
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Tiberias, Israel
Kaplan Medical Center; Oncology Inst.
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Rehovot, Israel
Ziv Medical Center; Oncology Department
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Sefad, Israel
Assaf Harofeh; Oncology
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Zerifin, Israel
Sourasky / Ichilov Hospital; Oncology Department
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Tel Aviv, Israel
Soroka Medical Center; Oncology Dept
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Beer Sheva, Israel
Carmel Hospital; Oncology Unit
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Haifa, Israel
Nahariya Hospital; Oncology
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Nahariya, Israel
Chaim Sheba Medical Center; Oncology Dept
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Ramat Gan, Israel