A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations

Open Label Study of Erlotinib (Tarceva®) as Single Agent First Line Treatment of Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With Activating Epidermal Growth Factor Receptor (EGFR) Mutations

This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR) activating mutations. Patients will receive Tarceva 150 mg orally daily until disease progression or unacceptable toxicity occurs.

Study Overview

• Status: Completed
• Conditions: Non-Squamous Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: erlotinib [Tarceva]

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1125
  • Budapest, Hungary, 1529
  • Debrecen, Hungary, 4032
  • Deszk, Hungary, 6772
  • Farkasgyepu, Hungary, 8582
  • Gyula, Hungary, 5703
  • Mosonmagyaróvar, Hungary, 9200
  • Mátraháza, Hungary, 3233
  • Nyiregyhaza, Hungary, 4400
  • Pecs, Hungary, 7623
  • Szekesfehervar, Hungary, 8001
  • Szekszard, Hungary, 7100
  • Szolnok, Hungary, 5004
  • Szombathely, Hungary, 9700
  • Torokbalint, Hungary, 2045
  • Törökbálint, Hungary, H-2045
• Latvia
  • Riga, Latvia, LV-1002
  • Riga, Latvia, LV 1079
• Turkey
  • Ankara, Turkey, 06230
  • Ankara, Turkey, 06280
  • Antalya, Turkey, 07070
  • Edirne, Turkey, 22030
  • Istanbul, Turkey, 34890

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Histologically or cytologically documented, inoperable, locally advanced, recurrent or metastatic (Stage IIIB or Stage IV) lung adenocarcinoma
• Non-small cell lung cancer with an EGFR activating mutation
• Patients must have evidence of disease, but measurable disease is not mandatory
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate renal and liver function

Exclusion Criteria:

• Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant chemotherapy is allowed if completed within 6 months prior to enrolment. Prior radiochemotherapy is allowed if completed more than 6 months before start of study treatment
• Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors
• Any other malignancies within 5 years, except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin carcinoma
• Brain metastasis or spinal cord compression not yet definitely treated with surgery and/or radiation
• Patients unable to take oral medication or requiring intravenous alimentation, with prior surgical procedures affecting absorption or active peptic ulcer disease
• Any significant ophthalmologic abnormality, especially those likely to increase the risk of corneal epithelial lesions; the use of contact lenses is not recommended during the study
• Pregnant or breast-feeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Drug: erlotinib [Tarceva]; 150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS was defined as median time from the first dose of study treatment to the first documentation of objective tumor progression (according to Response Evaluation Criteria in Solid Tumours [RECIST] version 1.1) or to death due to any cause, whichever occurred first. Progressive Disease (PD) was defined as at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Median and the 95% confidence interval were estimated using Kaplan-Meier survival methodology.	Baseline to progressive disease or death (up to 34 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Best Overall Response (BOR)	BOR was defined as best tumor response (as per RECIST version 1.1) recorded for a participant during the study. Complete Response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (less than [<] 10 millimeters [mm] short axis). Partial Response (PR): at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.	Baseline to progressive disease or death (up to 34 months)
Percentage of Participants Who Were Alive at 1 Year		1 Year (12 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Markoczy Z, Sarosi V, Kudaba I, Galffy G, Turay UY, Demirkazik A, Purkalne G, Somfay A, Papai-Szekely Z, Raso E, Ostoros G. Erlotinib as single agent first line treatment in locally advanced or metastatic activating EGFR mutation-positive lung adenocarcinoma (CEETAC): an open-label, non-randomized, multicenter, phase IV clinical trial. BMC Cancer. 2018 May 25;18(1):598. doi: 10.1186/s12885-018-4283-z.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: May 30, 2012
• First Posted (Estimate): June 1, 2012

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: December 29, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Adenocarcinoma; Adenocarcinoma of Lung; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Erlotinib Hydrochloride
• Other Study ID Numbers: ML27880; 2011-002168-26 (EudraCT Number)