A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NCT01667562 | Completed Phase 3 Results

• 1 other identifier: ML27860
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 4

Brief Summary

This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v 1.1)

  Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]) based on RECIST tumor response criteria or died from any cause, whichever occurred first. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Patients who had not died or progressed at the time of the final analysis were censored at the date of last contact.

  Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)

Secondary Outcomes (5)

• Proportion of Participants With Objective Response as Assessed by RECIST v 1.1

  Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)

• Proportion of Participants With Disease Control as Assessed by RECIST v 1.1

  Baseline until disease progression, or death, whichever occurs first (approximately up to 4 years and 9 months)

• Proportion of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations

  Screening up to approximately 7 days

• Percentage of Participants With Adverse Events

  Baseline up to approximately 4 years and 9 months

• Change From Baseline to End of Study in Quality of Life Score Using The Functional Assessment of Cancer Therapy Lung (FACT-L)

  Baseline and end of study (approximately 4 years and 9 months)

Study Arms (2)

Erlotinib

EXPERIMENTAL

Erlotinib will be administered as a single daily oral dose of 150 milligrams until disease progression, death or unacceptable toxicity.

Drug: Erlotinib

Diagnostic Phase

NO INTERVENTION

Participants with advanced or metastatic NSCLC were tested for EGFR mutations. Participants who did not have an EGFR mutation were excluded from the study.

Interventions

Erlotinib DRUG

Daily oral doses administered until disease progression or unacceptable toxicity or death.

Also known as: Tarceva

Erlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
• Measurable disease according to RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy greater than or equal to (\>/=) 12 weeks
• Adequate hematological, liver and renal function
• Participants with asymptomatic and stable cerebral metastases receiving medical treatment

You may not qualify if:

• Previous chemotherapy or treatment against EGFR for metastatic disease
• Treatment with an investigational agent less than 3 weeks before enrollment
• History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
• Participants with symptomatic cerebral metastases
• Any significant ophthalmologic abnormality
• Unstable systemic disease
• Coumarins use
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
• Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
• Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

Clinic for Pulmonology, Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Center Bezanijska Kosa; Oncology

Belgrade, 11080, Serbia

Location

Institute for pulmonary diseases of Vojvodina

Kamenitz, 21204, Serbia

Location

Clinical Center Nis; Clinic for pulmonary diseases Knez Selo

Niš, Serbia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 17, 2012
• Study Start: January 20, 2012
• Primary Completion: September 7, 2017
• Study Completion: September 7, 2017
• Last Updated: December 20, 2019
• Results First Posted: December 20, 2019

Record last verified: 2019-12

Locations

SE (4)