An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy - Full Text View

Purpose

This prospective, multicenter observational study will evaluate the efficacy, safety, and tolerability of Tarceva (erlotinib) as second-line treatment in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed after pemetrexed-containing first-line chemotherapy. Eligible patients will be followed until withdrawal of consent, lost-to-follow-up, or study termination, whichever occurs first.

Condition	Intervention
Non-Squamous Non-Small Cell Lung Cancer	Drug: Erlotinib


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Prospective, Open-label, Multicenter, National, Non-interventional Phase IV Trial of the Effectiveness, Safety and Tolerability of Tarceva as Second-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC), After Failure of First-line Treatment With a Pemetrexed-containing Chemotherapy Regimen

Resource links provided by NLM:

Genetics Home Reference related topics: lung cancer

MedlinePlus related topics: Lung Cancer

Drug Information available for: Pemetrexed Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 2 years) ] [ Designated as safety issue: No ]
Progression-free survival was defined as the time from the first dose of erlotinib to disease progression or death from any cause, whichever occurred earlier. Progressive disease was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter of target lesions recorded since treatment started, or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions.

Secondary Outcome Measures:

Best Overall Response [ Time Frame: Baseline to the end of the study (up to 2 years) ] [ Designated as safety issue: No ]
Reported are the percentage of participants with a best overall response of complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). The best overall response to treatment was determined by the Response Evaluation Criteria in Solid Tumors (RECIST). A CR was defined as the disappearance of all target lesions (TL) or the disappearance of all non-TLs. A PR was defined as at least a 30% decrease in the sum of the longest diameter (SLD) of TLs, taking as reference the baseline SLD. SD was defined as neither sufficient shrinkage to qualify for a PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since treatment started for TLs and the persistence of 1 or more non-TL(s). PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since treatment started or the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs.
Overall Survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Overall survival was defined as the time from Baseline until death from any cause.
Percentage of Participants Who Developed Rash [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Percentage of Participants Who Developed Diarrhea [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]


Enrollment:	57
Study Start Date:	September 2011
Study Completion Date:	August 2013
Primary Completion Date:	August 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Erlotinib Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.	Drug: Erlotinib Erlotinib was supplied as tablets in the retail product Tarceva. Other Name: Tarceva

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with locally advanced or metastatic non-small cell lung cancer initiated on second-line Tarceva therapy after first-line pemetrexed-containing chemotherapy.

Criteria

Inclusion Criteria:

Adult patients ≥ 18 years of age.
Histologically or cytologically documented locally advanced or metastatic non-small cell lung cancer (inoperable Stage III or IV according to the 7th TNM Classification of Malignant Tumors).
Experiencing disease progression after pemetrexed-containing first-line chemotherapy regimen.
Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
Initiated on second-line treatment with Tarceva at the most 4 weeks prior to study entry at baseline (date of signature of informed consent).

Exclusion Criteria:

Prior chemotherapy/targeted therapy after disease progression after first-line treatment in the advanced non-small cell lung cancer (NSCLC) setting.
Contraindication for Tarceva according to the Summary of Product characteristics.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01664533

Locations


Belgium

Aalst, Belgium, 9300

Antwerpen, Belgium, 2020

Boussu, Belgium, 7360

Bruxelles, Belgium, 1200

Charleroi, Belgium, 6000

Dendermonde, Belgium, 9200

Duffel, Belgium, 2570

Edegem, Belgium, 2650

Frameries, Belgium, 7080

Genk, Belgium, 3600

Gilly, Belgium, 6060

Gosselies, Belgium, 6041

Liege, Belgium, 4000

Mons, Belgium, 7000

Montegnée, Belgium, 4420

Namur, Belgium, 5000

Ottignies, Belgium, 1340

Roeselare, Belgium, 8800

Sint Niklaas, Belgium, 9100

Tournai, Belgium, 7500

Turnhout, Belgium, 2300

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche

More Information


Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01664533 History of Changes
Other Study ID Numbers:	ML25708
Study First Received:	August 10, 2012
Results First Received:	October 9, 2015
Last Updated:	November 23, 2015
Health Authority:	Belgium: Institutional Review Board

Additional relevant MeSH terms:


Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic	Bronchial Neoplasms Erlotinib Hydrochloride Pemetrexed Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016

An Observational Study of Erlotinib (Tarceva) as Second-line Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer After Failure of Pemetrexed in First-line Therapy (TIME)