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NSCLC Patients With EGFR Activating MutationPhase 3FLARENCT02178397

A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR

A Phase 3 study testing ERLOTINIB WITH CHEMOTHERAPY and CHEMOTHERAPY ONLY in people with NSCLC Patients With EGFR Activating Mutation, run by Centre Francois Baclesse at 35 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ERLOTINIB WITH CHEMOTHERAPY and CHEMOTHERAPY ONLY
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
35 sitesFrance
Study dates
Jun 2014to Sep 2015
Phase
Phase 3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Man or woman aged 18 years or more
  • Non-small cell lung cancer carcinoma (NSCLC) cytologically or histologically confirmed
  • Measurable disease according to RECIST 1.1 criteria
  • Life expectancy greater than 12 weeks
  • Performance Status (ECOG) ≤ 2
  • Stage IIIB considered ineligible for thoracic radiotherapy at "curative" doses or stage IV
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  • Presence of at least one measurable target lesion
  • Documented disease progression (RECIST 1.1) after first line treatment with erlotinib, during at least 4 months in case of partial or complete response according to RECIST criteria, or 6 months in case of stable disease. The treatment with Erlotinib should not be discontinued for more than 8 days between the progression and the inclusion in the study. The daily dose of Erlotinib should be at least 50 mg.
  • Presence of one of the EGFR activating mutations in the tumor (exon 19 deletion or L858R, G719X or L861Q)
  • One additional line of previous chemotherapy is allowed if administered in adjuvant or neoadjuvant setting and received more than six months before.
  • Prior radiotherapy is allowed if the volume of irradiated marrow is <25% of the total bone marrow. The prior radiotherapy must be completed at least two weeks before study entry
  • Brain metastases are allowed if they are controlled without steroids and if their treatment is completed (radiotherapy and/or surgery). Patients with no symptomatic brain metastases may be included; even if brain metastases are progressive and even if they are the only site of progression (since the investigator considers that irradiation is not required). These metastases have not to be life-threatening (are excluded: cerebellar metastasis ≥ 2 cm, brainstem metastasis, brain metastasis > 3 cm and/or near important functional structure).
  • Normal Liver function (bilirubin ≤ULN, AST - ALT ≤2.5 x ULN, alkaline phosphatase ≤3 x ULN), or in case of liver metastases: alkaline phosphatase, AST-ALT ≤ 5 x ULN
  • Normal renal function: blood creatinine ≤ULN and / or creatinine clearance> 60 ml/min calculated with the MDRD formula
  • Normal blood function: absolute neutrophil count ≥ 1.5 x 109/l and / or platelets ≥ 100 x 109 / l, hemoglobin> 9 g/dl
  • Woman and man under efficient contraception during treatment and at least 6 months after the end of treatment by pemetrexed or platinum or gemcitabine
  • Signed written Informed consent

Who cannot join

  • Bronchoalveolar, mixed, neuroendocrine and small cell lung cancers
  • Patient with only bone metastases are not eligible
  • All progressive metastatic sites treated locally (surgery, radiotherapy)
  • Superior vena cava syndrome
  • Uncontrolled cardiac disease requiring treatment
  • Congestive heart failure, angina pectoris, significant arrhythmias or history of myocardial infarction within the previous 12 months
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  • Neurological or psychiatric disorders
  • Uncontrolled infectious disease
  • Peripheral neuropathy grade≥ 2
  • Definitive contraindication for the use of steroids
  • Inductive anti-epileptic treatments (phenobarbital, phenytoïne)• Previous or concomitant other cancer, including skin cancer (except basal cell cancer of the skin), except in situ treated carcinoma of the cervix , except cancer treated with surgery alone without recurrence for 5 years
  • Pregnant or breastfeeding woman
  • Patient follow-up not achievable
  • Participation in a trial within the last 30 days
  • Patient deprived of liberty as a result of a justice or administrative decision

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

France35 sites

  • CH

    Aix-en-Provence

  • CH

    Amiens

  • CHRU

    Angers, 49933

  • CH

    Annecy, 74374

  • CHU

    Brest, 29609

  • Centre François BACLESSE

    Caen, 14000

  • CHIC

    Créteil, 94000

  • CH

    Draguignan, 83007

  • CH

    Elbeuf

  • CHIC

    Gap, 05007

  • Ch La Roche/Yon

    La Roche/yon

  • Centre Hospitalier

    Le Mans, 72037

  • Centre Oscar Lambret

    Lille, 59020

  • CHU

    Limoges, 87042

  • CH

    Longjumeau, 91160

  • CH

    Lorient, 35632

  • CH

    Mâcon, 71018

  • CH

    Mantes-la-Jolie, 78201

  • Institut Paoli Calmettes

    Marseille, 13273

  • AP-HM - Hôpital Nord

    Marseille

  • CH

    Meaux, 77104

  • Centre Hospitalier Intercommunal

    Meulan-en-Yvelines, 78250

  • CH

    Pau

  • Centre Catalan

    Perpignan

  • CHU

    Rennes, 35033

  • CH

    Roanne

  • CHU

    Rouen

  • CH

    Saint-Brieuc

  • Institut de Cancérologie de la Loire

    Saint-Etienne, 42271

  • CH

    Salon-de-Provence

  • CH

    Sens, 89100

  • Centre Paul Strauss

    Strasbourg, 67065

  • CH

    Tarbes

  • Hôpital d'instruction des Armées Sainte-Anne

    Toulon, 83041

  • CH

    Villefranche, 69655

Other trials in France

About this study

The current first line treatment of patients with EGFR activating mutation lung cancer is EGFR TKI. Compared to platinum-based chemotherapy, EGFR-TKIs are superior in terms of response rate and progression-free survival. However, an acquired resistance occurs almost constantly. The second-line treatment includes platinum-based chemotherapy in the absence of contraindication. This chemotherapy is then administered after discontinuing EGFR TKIs.

However, a rebound phenomenon of the disease was described in patients who discontinued EGFR TKIs. Some clinical teams therefore recommend, as a precaution, in order to avoid any withdrawal phenomenon, to never discontinue EGFR TKIs in patients developing an EGFR TKI acquired resistance.

It seems therefore useful to conduct a study to better define the therapeutic strategy to adopt in patients developing an acquired resistance after having received EGFR TKIs as first line treatment.

Being tested
ERLOTINIB WITH CHEMOTHERAPY, CHEMOTHERAPY ONLY
Keywords
erlotinib, lung cancer, EGFR mutation
Medical subject headings
Lung Neoplasms

What participants receive

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

  • ERLOTINIB WITH CHEMOTHERAPYDrug

  • CHEMOTHERAPY ONLYDrug

Study groups in NCT02178397
Study groupRoleWhat they receive
EXPERIMENTAL ARM BExperimentalINDUCTION chemotherapy: 4 cycles of * pemetrexed with cisplatin or carboplatin * or gemcitabine with cisplatin or carboplatin in combination with erlotinib THEN, for responders and for patients with stable disease :MAINTENANCE chemotherapy by Pemetrexed in combination with erlotinib
Receives: Drug: ERLOTINIB WITH CHEMOTHERAPY
STANDARD ARM AActive comparatorINDUCTION chemotherapy: 4 cycles of * pemetrexed with cisplatin or carboplatin * or gemcitabine with cisplatin or carboplatin THEN, for responders and for patients with stable disease :MAINTENANCE chemotherapy by Pemetrexed
Receives: Drug: CHEMOTHERAPY ONLY

What is being measured

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

  1. Efficacy by PFS

    Efficacy will be assessed by the PFS, define as time between randomization of the patient in the study and disease progression (local, regional, distant and second cancer) or death (all causes). Alive patients free of progression will be censored at the last follow-up.

    Measured: From date of randomization until the date of first documented progression evaluated every 6-9 weeks

Secondary outcomes (5)

  1. scores of QoL

    difference between the scores of QoL at baseline and at 4 months after inclusion for the three targeted dimensions of EORTC QLQ-C30 (global quality of life, fatigue and physical functioning). A difference or 10 points or more at 4 months after inclusion for one score between the 2 arms will be considered as clinically relevant.

    Measured: at 4 months after inclusion

  2. Overall survival

    Overall survival defined as time interval between randomization and death (all causes). Alive patients will be censored at the last date of news or data cut off

    Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months

  3. Tumoral response

    Tumoral response (complete response, partial response, stable disease, progression) according to RECIST 1.1

    Measured: every 6-9 weeks

  4. Toxicities

    Toxicities according to NCI-CTC-AE v.4

    Measured: From date of randomization until study participation, assessed up to 100 months

  5. Rebound phenomenon (flare)

    Rebound phenomenon (flare) defined by a hospitalization or a death within 3 weeks for disease progression after the end of TKI EGFR treatment (in the arm without EGFR TKI) and date of onset

    Measured: within 3 weeks after disease progression before inclusion

Timeline

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

  1. First posted30 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Why it stopped: lack of recruitment

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02178397
Sponsor's protocol ID
FLARE /GFPC 03-2013
Acronym
FLARE
Status last verified
Jul 2016
First submitted
25 Jun 2014
Last updated
17 Jul 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ERLOTINIB WITH CHEMOTHERAPY and CHEMOTHERAPY ONLY in people with NSCLC Patients With EGFR Activating Mutation, run by Centre Francois Baclesse at 35 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 17 inclusion and 15 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: stopped early, as of the sponsor's last update on 17 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: lack of recruitment). Results are not available in the source record.

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?

Efficacy by PFS (time frame: From date of randomization until the date of first documented progression evaluated every 6-9 weeks). 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 NCT02178397.

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 17 Jul 2017.

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