Phase III Study (Tarceva®) vs Chemotherapy to Treat Advanced Non-Small Cell Lung Cancer in Patients With Mutations in the TK Domain of EGFR (EURTAC)

June 8, 2022 updated by: Spanish Lung Cancer Group

Phase III, Multicenter, Open-label, Randomized Trial of Tarceva® vs Chemotherapy in Patients With Advanced NSCLC With Mutations in the TK Domain of the EGFR

A Phase III, multicenter, open-label, randomized trial of Erlotinib (Tarceva®) versus chemotherapy in patients with advanced NSCLC with mutations in the Tyrosine Kinase (TK) domain of the EGFR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, phase III, randomized, open-label clinical trial.

146 patients with a diagnosis of advanced (stage IIIB and stage IV), non-squamous-cell, non-small-cell pulmonary carcinoma not treated previously for their disease with chemotherapy who present mutation in the tyrosine kinase domain of the epidermal growth factor receptor, EGFR will be recluted.

The primary objective is to compare the progression-free survival in both treatment arms of the study (conventional chemotherapy vs. erlotinib) in patients with non-squamous-cell, non-small-cell lung cancer (NSCLC) in advanced stage (stages IIIB and stage IV) who have not received previous chemotherapy for their disease and who present mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR).

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • Centre Hospitalier Universitaire d'Angers
      • Brest, France, 29200
        • Hôpital Auguste Morvan
      • Caen, France, 14000
        • Centre Francois Baclesse
      • Cergy Pontoise, France
        • Centre Hospitalier Rene Dubos
      • Creteil, France, 94010
        • Centre Hospitalier Intercommunal
      • Le Chesnay, France
        • Hôpital A. Mignot
      • Le Mans, France
        • Centre Hospitalier du Mans
      • Lille, France, 59000
        • Centre Oscar Lambret
      • Limoges, France, 87042
        • Hôpital du Cluzeau
      • Longjumeau, France
        • Centre Hospitalier Régional
      • Meaux, France
        • Centre Hospitalier de Meaux
      • Mulhouse, France
        • Centre Hospitalier de Mulhouse
      • Paris, France, 75571
        • Hopital Saint Antoine
      • Perigueux, France
        • Centre Hospitalier
      • Pringy, France
        • Centre Hospitalier de la Région d'Annecy
      • Rennes, France, 35033
        • CHU Rennes Hôpital Ponchaillou
      • Roanne, France
        • Centre Hosiptalier Genéral de Roanne
      • St-Priest en Jarez, France
        • Institut de Cancerologie de La Loire
      • Toulouse, France, 31059
        • Hopital Larrey
  • Italy
      • Aviano, Italy, 33081
        • CRO di Aviano
      • Catanzaro, Italy, 88100
        • AO Materdomini
      • Messina, Italy, 98125
        • AOU Policlinico G. Martino
      • Napoli, Italy, 80131
        • AO Monaldi
      • Palermo, Italy, 90146
        • Casa di Cura "La Maddalena"
      • Roma, Italy, 00128
        • Istituti Fisioterapici Ospitalieri
      • Roma, Italy, 00149
        • AO S.Camillo Forlanini
      • Roma, Italy, 00161
        • Università di Roma "La Sapienza" Az.Policlinico Umb.I°
      • Sassari, Italy, 07100
        • PO di SS.ma Annunziata
  • Spain
      • Alicante, Spain
        • H.G.U. Alicante
      • Barcelona, Spain, 08028
        • Instituto Universitario Dexeus
      • Barcelona, Spain, 08243
        • H. Althaia
      • Barcelona, Spain, 08907
        • H. Duran i Reynals-ICO
      • Barcelona, Spain, 08036
        • H. Clinic i Provincial
      • Barcelona, Spain, 08035
        • H.U.Vall D´Hebrón
      • Barcelona, Spain, 08025
        • H. Santa Creu i Sant Pau
      • Córdoba, Spain, 14004
        • H. Reina Sofia
      • Girona, Spain, 17007
        • ICO Girona -H. Dr. Josep Trueta
      • Granada, Spain, 18014
        • H. Virgen de las Nieves
      • Jaén, Spain, 23007
        • Complejo Hospitalario de Jaen
      • La Coruña, Spain, 15006
        • Complejo Hosp. Univ. Juan Canalejo
      • Logroño, Spain
        • Hospital San Millan Y San Pedro
      • Lérida, Spain, 25198
        • H. Arnau de Vilanova
      • Madrid, Spain, 28040
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • H. 12 de Octubre
      • Madrid, Spain, 28035
        • H.U. Puerta de Hierro
      • Madrid, Spain, 28006
        • H. de la Princesa
      • Madrid, Spain
        • H. Ramon y Cajal
      • Madrid, Spain, 28007
        • H. Gregorio Maranon
      • Madrid, Spain, 28034
        • H. Ruber Internacional
      • Madrid, Spain, 28040
        • Hospial Clinico San Carlos
      • Madrid, Spain, 28046
        • H. La Paz
      • Málaga, Spain, 29010
        • H. Carlos Haya
      • Málaga, Spain, 29010
        • H.C.Universitario Virgen de la Victoria
      • Palma de Mallorca, Spain
        • Clinica Rotger
      • Palma de Mallorca, Spain, 07198
        • H. Son Llàtzer
      • San Sebastian, Spain, 20014
        • H. de Donostia
      • Sevilla, Spain, 41013
        • H. Virgen del Rocio
      • Sevilla, Spain, 41014
        • H. Nuestra Sra. de Valme
      • Valencia, Spain, 46010
        • H.C.U.Valencia
      • Valencia, Spain, 46014
        • H. General U. de Valencia
      • Valencia, Spain, 46015
        • H. Arnau de Vilanova Valencia
      • Valencia, Spain, 46017
        • H. Dr. Peset
      • Zaragoza, Spain, 50009
        • H. Miguel Servet
      • Zaragoza, Spain, 59009
        • H. Clínico Lozano Blesa
    • Alicante
      • Alcoy, Alicante, Spain, 03804
        • H. Virgen de los Lirios
      • Torrevieja, Alicante, Spain, 03193
        • H. Torrevieja Salud
    • Barcelona
      • Badalona, Barcelona, Spain
        • ICO - H. Germans Trias i Pujol
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataro
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • H. Marques De Valdecilla
    • Castellón
      • Castelló de la Plana, Castellón, Spain, 12002
        • H. Provincial de Castellón
    • Las Palmas
      • Las Palmas De Gran Canaria, Las Palmas, Spain, 35016
        • Hospital Insular Gran Canaria
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • F.H.Alcorcón
      • Fuenlabrada, Madrid, Spain, 28942
        • H. Fuenlabrada
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07014
        • H. Son Dureta
    • Tenerife
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • H. Ntra. Sra. de la Candelaria
    • Vizcaya
      • Baracaldo, Vizcaya, Spain, 48903
        • Hospital de Cruces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Informed consent
  • Histologically confirmed diagnosis of NSCLC, non epidermoid, stage IV or IIIB with pleural effusion, or N3 tumours not candidate for thoracic radiotherapy, harbouring deletions in the exon 19 or mutation in the exon 21 in the TK of the EGFR.
  • Either measurable or evaluable disease.
  • Age > 18 years.
  • ECOG performance status < 2.
  • Adequate bone marrow function
  • Adequate renal function
  • Adequate hepatic function
  • Patients must be accessible for treatment and follow-up.
  • Patients capable of following an adequate therapeutic compliance
  • Women of child bearing potential: negative pregnancy test.
  • Patients of both genders at a fertile age, including those women having their last menstruation within the two previous years, must follow effective contraceptive measures.
  • Ability to swallow.
  • Patients with asymptomatic brain metastasis and stable with medical treatment will be eligible for the study. Patients having received radiotherapy for their brain metastasis prior to the systemic treatment for the NSCLC will be also eligible.
  • Absence of gastrointestinal tract problems

Exclusion criteria:

  • Pregnant or lactating women.
  • Women of child bearing potential having a positive pregnancy test in the basal visit or not accomplishing the test.
  • Patients of both genders sexually active (at a fertile age) not following contraceptive measures during the study.
  • Prior chemotherapy for metastatic disease. Both prior neoadjuvant and adjuvant chemotherapy allowed provided that completed ≥ 6 months before entering the study.
  • Prior treatment with EGFR targeted therapies.
  • Patients may have received radiotherapy, provided that the irradiated lesion is not the only evaluable lesion for response and completed before entering the study.
  • Prior experimental pharmacological agent within the 3 weeks prior to the inclusion of the study.
  • Any significant ophthalmologic impairment of the eye surface. Use of contact lenses is not recommended.
  • Pre-existing motor or sensorial neurotoxicity grade > 2, according to the NCI-CTC criteria.
  • Evidence of spinal cord compression.
  • Inability to take oral medication and surgical procedures affecting the absorption or implying intravenous or parenteral feeding.

  • Any other severe disease or clinical conditions, as, but not only:

    • Unstable cardiopathy despite treatment, myocardial infarction within the 6 months before entering the study
    • History of significant neurological or psychiatric disorders, including dementia and epileptic seizures.
    • Uncontrolled active infection.
    • Uncontrolled peptic ulcer.
    • Unstable diabetes mellitus or any other contraindication for treatment with corticosteroids.
    • AST and/or ALT > 1.5 x UNL associated to alkaline phosphatase > 2.5 x UNL.
    • Any other underlying severe process affecting the ability to take part in the study.
  • Absolute contraindication for steroids.
  • Dementia or significant mental disorder interfering the understanding and giving the informed consent.
  • History of other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, radically treated prostatic carcinoma with good prognostic (Gleason = 6). History of other curatively treated malignancy and no evidence of disease within the past 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A

Erlotinib (Tarceva)150 mg /day

Patients will receive treatment until disease progression or unacceptable toxicity.

For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib
Drug: Erlotinib

150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.

For all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib

Other Names:
  • Tarceva
Active Comparator: B

4 cycles of Chemotherapy:

Cisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.

- Cisplatin plus docetaxel: cisplatin 75 mg/m2 i.v. day 1 and docetaxel 75 mg/m2 i.v.

day 1. Repeat cycles every 3 weeks.

- Cisplatin plus gemcitabine: Cisplatin 75 mg/m2 i.v. on day 1 and gemcitabine 1250 mg/m2 on days 1 and 8. Repeat cycles every 3 weeks.

In the case of patients not eligible for treatment with cisplatin, cisplatin can be replaced by carboplatin. The schedules will be the following:

Docetaxel 75 mg/m2 day 1 and carboplatin AUC = 6 day 1, every 21 days.

Gemcitabine 1000 mg/m2 days 1 and 8 and carboplatin AUC = 5 day 1, every 21 days.

Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
Drug: Carboplatin

Gemcitabine 1000 mg/m2 days 1 and 8 and Carboplatin AUC = 5 day 1, every 21 days.

Docetaxel (75 mg/m2) /carboplatin (AUC=6); Gemcitabine (1000 mg/m2; day 1 and 8) / Carboplatin (AUC=5)

Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.

Other Names:
  • Paraplatin
Drug: Gemcitabin
Cisplatin (75 mg/m2) / Gemcitabine (1250 mg/m2; day 1 and 8) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
Other Names:
  • Gemzar
Drug: Docetaxel
Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
Other Names:
  • Taxotere
Drug: Cisplatin
Cisplatin (75 mg/m2) / Docetaxel (75 mg/m2) Patients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.
Other Names:
  • Platinol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free-survival
Time Frame: From the date of randomization to the date of last follow up, assessed up to 24 months
The time from enrollment in the study to tumor progression or death from any cause (whichever occurs first)
From the date of randomization to the date of last follow up, assessed up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response
Time Frame: From the date of randomization to the date of last follow up, assessed up to 24 months
The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria.
From the date of randomization to the date of last follow up, assessed up to 24 months
One year survival
Time Frame: From the date of randomization to the one year after initiation of treatment.
Proportion of patients who are still alive one year after enrollment in the study.
From the date of randomization to the one year after initiation of treatment.
Overall survival
Time Frame: From the date of randomization to the date of last follow up, assessed up to 24 months
Overall survival will be assessed from the date of enrollment in the study until the date of death from any cause. Patients lost to follow-up will be censured on the date of the last follow-up visit.
From the date of randomization to the date of last follow up, assessed up to 24 months
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Time Frame: From the subject's written consent to participate in the study through 30 days after the final administration of the drug
Occurrence and severity of adverse events, with severity determined by NCI CTCAE v3.0 criteria
From the subject's written consent to participate in the study through 30 days after the final administration of the drug
Life quality
Time Frame: At baseline, every 3 weeks during treatment period, end of treatment visit and every 3 months during follow up period.
Changes in the scores obtained with the LCSS validated questionnaire throughout the course of the study will be analyzed to assess change in the patient's quality of life.
At baseline, every 3 weeks during treatment period, end of treatment visit and every 3 months during follow up period.
Molecular markers related to EGFR and study pathology
Time Frame: At baseline, after 6 months of inclusion and at progression.
The study of mutations in serum (serum DNA)
At baseline, after 6 months of inclusion and at progression.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Lung Cancer Group

Investigators

  • Study Chair: Rafael Rosell i Costa, MD, Spanish Lung Cancer Group
  • Study Chair: Luis Paz-Ares, MD, Spanish Lung Cancer Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 8, 2007

First Submitted That Met QC Criteria

March 9, 2007

First Posted (Estimate)

March 12, 2007

Study Record Updates

Last Update Posted (Actual)

June 13, 2022

Last Update Submitted That Met QC Criteria

June 8, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EURTAC-SLCG // GECP06/01
  • 2006-003568-73 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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