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

Non-Squamous Non-Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174563
• Other study ID #: ML25200
• Status: Completed
• Phase: Phase 2
• Start date: May 23, 2011
• Est. completion date: December 20, 2016

Study information

• Verified date: September 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 20, 2016
• Est. primary completion date: December 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• erlotinib [Tarceva]
150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Hoffmann-La Roche	Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 of treatment period until disease progression or death (approximately up to 67 months)
Secondary	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)
Secondary	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.	Day 1 of treatment period until disease progression or death (approximately up to 67 months)