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Stage IV Lung CancerPhase 2LADIENCT01556191

Lung Cancer in Women Treated With Anti-oestrogens anD Inhibitors of EGFR

A Phase 2 study testing Gefitinib, Fulvestrant and Erlotinib in people with Stage IV Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 61 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Stage IV Lung Cancer
What is being tested?
Gefitinib, Fulvestrant and Erlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
379 participants
Where
61 sitesFrance
Study dates
15 May 2012to 17 Jun 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed predominant non-squamous, non-small cell lung cancer
  • The presence of analysable tissue for the research of EGFR activating mutation. Analysis must be performed in INCa-labelled laboratories or platforms according to a validated technique
  • Not suitable for radiation, inoperable stage III or stage IV
  • Patients with an EGFR mutation must never have taken chemotherapy or must be in progression after only one previous line of chemotherapy (including maintenance). Patients without an EGFR mutation must have received one or two lines of chemotherapy beforehand. Maintenance chemotherapy is not considered to be a treatment line. Adjuvant chemotherapy is not considered to be a first line of treatment if it dates back to over a year
  • Female
  • Menopausal: older than 60 years of age or history of ovariectomy or younger than 60 years old with amenorrhoea for more than 12 months or an FSH rate that corresponds to a post-menopausal rate (according to the laboratory)

Who cannot join

  • History of cancer except for skin cancer or cancer dating from over five years ago and considered to be cured
  • Known or suspected Cerebral metastases or spinal cord compression unless they are asymptomatic without treatment or stable after being treated by surgery and/or radiation therapy. Corticosteroid treatments for symptoms must have discontinued for more than four weeks
  • Pregnancy and breast-feeding
  • Patient taking hormone replacement therapy for menopause that has not been stopped two weeks before the start of the trial treatment
  • A change in bone marrow, kidney and liver functions inconsistent with treatment

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

France61 sites

  • Annemasse - CH

    Ambilly, 74100

  • Clinique de l'Europe

    Amiens

  • Angers - CHU

    Angers, 49000

  • CH de la Côte Basque

    Bayonne

  • CHU Besancon - Pneumologie

    Besançon, 25000

  • Béziers - CH

    Béziers, 34525

  • Bobigny - Hôpital Avicenne

    Bobigny, 93000

  • Hôpital Ambroise Paré - Pneumologie

    Boulogne

  • HCL Hôpital Louis Pradel

    Bron

  • Caen - Centre François Baclesse

    Caen, 14000

  • Caen - CHU Côte de Nacre

    Caen, 14000

  • Cahors - CH

    Cahors, 46000

  • Chambéry - CH

    Chambéry

  • Centre Hospitalier

    Chauny

  • Hôpital de Cholet - Pneumologie

    Cholet

  • Clamart - Hôpital Percy

    Clamart, 92140

  • CHU

    Clermont-Ferrand

  • CH

    Colmar

  • Clinique des Cèdres

    Cornebarrieu

  • Créteil - CHI

    Créteil, 94000

  • CH de Dax

    Dax

  • Dijon - CAC

    Dijon, 21000

  • Grenoble - CHU

    Grenoble, 38000

  • Chartres - CH

    Le Coudray, 28630

  • Centre Hospitalier - Pneumologie

    Le Mans, 72000

  • CHU (Hôpital Calmette) - Pneumologie

    Lille, 59000

  • CH

    Longjumeau

  • Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques

    Marseille

  • Institut Paoli Calmette

    Marseille

  • Polyclinique du Val de Sambre

    Maubeuge

  • Mont de Marsan - CH

    Mont-de-Marsan, 40000

  • Mulhouse - CH

    Mulhouse, 68000

  • CHU Nancy

    Nancy

  • Nantes - Centre René Gauducheau

    Nantes, 44805

  • Nevers - CH

    Nevers, 58033

  • Centre Antoine Lacassagne

    Nice

  • Hopital Tenon - Pneumologie

    Paris, 75020

  • HIA Val-de-Grâce

    Paris

  • Hôpital Bichat - Claude - Bernard

    Paris

  • Hôpital Européen Georges Pompidou

    Paris

  • Hôpital Saint-Joseph

    Paris

  • Paris - Curie

    Paris

  • Pau - CH

    Pau, 64046

  • Perpignan - Ch

    Perpignan, 66046

  • HCL - Lyon Sud (Pneumologie)

    Pierre-Bénite, 69495

  • Centre Hospitalier

    Rambouillet

  • CHU de Reims

    Reims

  • Institut Jean Godinot

    Reims

  • Rouen - CHU

    Rouen, 76000

  • Saint Quentin - CH

    Saint-Quentin, 02100

  • Strasbourg - NHC

    Strasbourg, 63000

  • Suresnes - Hopital Foch

    Suresnes, 92151

  • Centre Hospitalier Intercommunal

    Toulon

  • Clinique Pasteur

    Toulouse

  • Toulouse - CHU Larrey

    Toulouse

  • Tourcoing - CH

    Tourcoing, 59208

  • CHU Tours - Pneumologie

    Tours

  • Versailles - CH

    Versailles, 78157

  • CHI de la Haute-Saône - Pneumologie

    Vesoul

  • CH de Villefranche - Pneumologie

    Villefranche

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: Phase II Randomised Clinical Trial Evaluating an EGFR Tyrosine Kinase Inhibitor (EGFR-TKI) Versus an EGFR-TKI Combined With an Anti-oestrogen Treatment (Fulvestrant) in Women With Advanced Stage Non-squamous Lung Cancer

Lung Cancer is to become the first cause of death related to cancer in France as it's already the case in United States. At Present, Lung Cancer in women and in men is treated similarly. Nevertheless, numerous studies shows that lung cancer in women has specificities : at the time of the diagnosis female patients are younger, there are less clinical signs, clinical stages are earlier, histology is often adenocarcinoma. The link with tabagism is weaker . Sensitivity to tabagism is higher (more cancer in women with the same tabagism). Response rate to chemotherapy is better. Prognosis is better

Numerous hypotheses have been put forward to account for the specific characteristics of female lung cancer described above.

Read more
  • One hypothesis is that there are different genetic anomalies in women. Some studies show an increase of EGFR mutation and HER2 expression and a decrease of expression of repair enzymes (ERCC1, RRM1, BRCA) which can explain the increase sensitivity to tabagism and to chemotherapy.
  • Another hypothesis is that hormones play a role in oncogenesis. Indeed, lung cancer presents hormonal risk factors : pre-menopause, less than 3 kids, short menstrual cycle, hormone replacement therapy. Estrogens would have a deleterious effect on cancer incidence and on survival of lung cancer in women. Cellular and animal models show that ER pathway is activated in lung cancer and participates in oncogenesis.
  • Moreover an interaction between RE and EGFR pathway has been demonstrated on lung cancer cell lines and mouse models.

EGFR-TKI have shown benefit in women with wild type EGFR or unknown status (with erlotinib) and in women with EGFR mutations (with gefitinib). In this study, the use of these two treatment will be in accordance with their market authorisations.

The objective of this study is to test the addition of an anti-estrogen (fulvestrant) to EGFR-TKI. Fulvestrant is a pure anti-oestrogen that binds to ER, blocks it and accelerates its breakdown. It has a market authorisation in breast cancer. Furthermore the association between EGFR-TKI and anti-estrogen could have a synergetic effect due to interaction between RE and EGFR pathways .

Keywords
lung cancer, women
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GefitinibDrug

    250 mg per day (oral)

  • FulvestrantDrug

    500 mg (2 x 250 mg), IV by month with an additional 500 mg dose two weeks after the initial dose

  • ErlotinibDrug

    150 mg per day (oral)

Study groups in NCT01556191
Study groupRoleWhat they receive
Gefinitib + Fulvestrant (patient with EGFR mutations)ExperimentalNot described
Receives: Drug: Gefitinib; Drug: Fulvestrant
Erlotinib (wild type patients)Active comparatorNot described
Receives: Drug: Erlotinib
Erlotinib + Fulvestrant (wild type patients)ExperimentalNot described
Receives: Drug: Fulvestrant; Drug: Erlotinib
Gefinib (patient with EGFR mutations)Active comparatorNot described
Receives: Drug: Gefitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression-free survival

    From date of randomization until the date of first progression for EGFR mutated patient

    Measured: Around nine months

  2. Progression free survival

    From date of randomization until the date of first progression for EGFR wild type patients

    Measured: Around three months

Secondary outcomes (5)

  1. toxicity of EGFR-TKI and fulvestrant

    The number of patients for whom at least an adverse event will have been reported, the number of events, according to the relation to the treatment, the intensity, and the cycle of appearance for EGFR WT patients

    Measured: Around three months

  2. Response rate

    For EGFR WT patients

    Measured: Around three months

  3. Overall survival

    For all patients

    Measured: Up to 18 months

  4. toxicity of EGFR-TKI and fulvestrant

    The number of patients for whom at least an adverse event will have been reported, the number of events, according to the relation to the treatment, the intensity, and the cycle of appearance for EGFR mutated patients

    Measured: Around Nine months

  5. Response rate

    For EGFR-Mutated patients

    Measured: Around nine months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2012 (estimated)
  2. Study start15 May 2012
  3. Primary completion15 May 2018
  4. Study completion17 Jun 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
379 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01556191
Sponsor's protocol ID
IFCT-1003
Acronym
LADIE
Status last verified
Jan 2021
First submitted
8 Mar 2012
Last updated
8 Jan 2021
Results posted
No
Data monitoring committee
No

Publications

  • Mazieres J, Barlesi F, Rouquette I, Molinier O, Besse B, Monnet I, Audigier-Valette C, Toffart AC, Renault PA, Fraboulet S, Hiret S, Mennecier B, Debieuvre D, Westeel V, Masson P, Madroszyk-Flandin A, Pichon E, Cortot AB, Amour E, Morin F, Zalcman G, Moro-Sibilot D, Souquet PJ. Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial. Clin Cancer Res. 2020 Jul 1;26(13):3172-3181. doi: 10.1158/1078-0432.CCR-19-3056. Epub 2020 Mar 6.

    PubMed 32144133

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gefitinib, Fulvestrant and Erlotinib in people with Stage IV Lung Cancer, run by Intergroupe Francophone de Cancerologie Thoracique at 61 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

progression-free survival (time frame: Around nine months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01556191, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.

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