Non Small Cell Lung Cancer (Squamous or Non Squamous)Phase 3MODELNCT01850303
Maintenance After Induction Chemotherapy in Elderly Patients With Advanced Non-small Cell Lung Cancer
A Phase 3 study testing Pemetrexed, Gemcitabine and Induction chemotherapy in people with Non Small Cell Lung Cancer (Squamous or Non Squamous), run by Intergroupe Francophone de Cancerologie Thoracique at 78 sites in France.
Trial summary
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. Read more about this study
- Who is it for?
- Ages 70 to 89 years
- Conditions the study is for
- Non Small Cell Lung Cancer (Squamous or Non Squamous)
- What is being tested?
- Pemetrexed, Gemcitabine and Induction chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 78 sitesFrance
- Study dates
- 16 May 2013to 31 Jan 2020
- 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 70 to 89 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Histologically or cytologically documented Non Small Cell Lung Cancer non resectable or non irradiable stage III or stage IV
- EGFR wild type or non feasible EGFR
- 90 >Age ≥ 70
- ECOG Performance status : 0, 1 or 2
- Mini-Mental Test Status (MMS) > 23
Who cannot join
- Mixed non-small cell and small cell tumors
- Patients with EGFR mutated tumor
- Patient with EML4-ALK translocation
- Evolutive or symptomatic metastasis of central nervous system
- Superior vena cava syndrome
- Calcemia > 2,70 mmol/L
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
France78 sites
Abbeville - CH
Abbeville, 80142
Centre Hospitalier du Pays d'Aix
Aix-en-Provence
Amiens - CHU
Amiens
Clinique de l'Europe
Amiens
Annecy - CH
Annecy, 74374
Auxerre - CH
Auxerre, 89011
CH de la Côte Basque
Bayonne
CHU Besancon - Pneumologie
Besançon, 25000
Blois - CH
Blois, 41016
APHP - CHU Avicenne - Oncologie Medicale
Bobigny, 93000
CH Pierre Oudot
Bourgoin
Brest - Clinique Pasteur
Brest
Caen - Centre François Baclesse
Caen, 14000
CHU Côte de Nâcre
Caen
CH Cahors
Cahors
CH de Cannes
Cannes
Chauny - CH
Chauny
Hôpital de Cholet - Pneumologie
Cholet
Clamart - Hôpital Percy
Clamart, 92140
Hôpitral Gabriel Montpied - Pneumologie
Clermont-Ferrand
CH
Colmar
CH Compiègne - Pneumologie
Compiègne
CHI Créteil
Créteil
CH de Dax
Dax
CHU Hôpital du Bocage
Dijon
Foix - CH
Foix
CHU Grenoble - pneumologie
Grenoble, 38000
Saint Omer - CHI
Helfaut, 62570
Jonzac - CH
Jonzac, 17500
Chartres - CH
Le Coudray, 28630
Le Mans - Centre Hospitalier
Le Mans, 72000
Institut d'Oncologie Hartmann
Levallois-Perret
CH de Longjumeau
Longjumeau
Lorient - CHBS
Lorient
Lyon - Clinique Mutualiste
Lyon, 69003
CH Saint Joseph Saint Luc
Lyon
Hôpital de la Croix Rousse
Lyon
Hôpital Louis Pradel
Lyon
Lyon - Clinique de la Sauvegarde
Lyon
Lyon - Hôpital Jean Mermoz
Lyon
CH de Macon
Mâcon
Hôpital Ambroise Paré
Marseille
Hôpital Nord - Oncologie Multidisciplinaire & Innovations Thérapeutiques
Marseille
Institut Paoli Calmette
Marseille
Maubeuge - Polyclinique du Parc
Maubeuge, 59600
Polyclinique du Val de Sambre
Maubeuge
Metz - Belle Isle
Metz
Mont de Marsan - CH
Mont-de-Marsan, 40000
Montargis - CH
Montargis
Montbéliard - CH
Montbéliard
Centre Hospitalier
Montélimar
Montpellier - CHRU
Montpellier, 34295
Mulhouse - CH
Mulhouse, 68000
CHU Nancy
Nancy
Nevers - CH
Nevers, 58033
Centre Antoine Lacassagne
Nice
Orléans - CH
Orléans, 45000
Paris - Saint Louis
Paris, 75000
Hopital Tenon - Pneumologie
Paris, 75020
GH Paris Saint-Joseph
Paris
CHG de Pau
Pau
Perpignan - Centre Catalan d'Oncologie
Perpignan, 66000
Perpignan - Ch
Perpignan, 66046
Lyon Sud
Pierre-Bénite, 69495
Rennes - CHU
Rennes
Roubaix - CH
Roubaix, 59100
Saint-Nazaire - Clinique Mutualiste de l'Estuaire
Saint-Nazaire
Centre Hospitalier
Saint-Quentin
Strasbourg - NHC
Strasbourg, 63000
Suresnes - Hopital Foch
Suresnes, 92151
Toulon - CHI
Toulon, 83000
Hôpital Larrey - Pneumologie
Toulouse
Tours - CHU
Tours, 37000
Troyes - CH
Troyes, 10000
Valenciennes - Clinique
Valenciennes, 59304
Vernon - CHI
Vernon
Versailles - CH
Versailles, 78157
CH de Villefranche - Pneumologie
Villefranche
About this study
Official title: Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).
There is two types of maintenance :
Read more
- continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.
- switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.
Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.
The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
- Being tested
- Pemetrexed, Gemcitabine, Induction chemotherapy
- Keywords
- Elderly, lung cancer, switch, maintenance, Elderly patients (between 70 and 89 years), NSCLC, IFCT
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
GemcitabineDrug
Induction chemotherapyDrug
4 cycles of carboplatin-paclitaxel
| Study group | Role | What they receive |
|---|---|---|
| Surveillance | Other | Not described Receives: Drug: Induction chemotherapy |
| Maintenance | Experimental | Pemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC Receives: Drug: Pemetrexed; Drug: Gemcitabine; Drug: Induction chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: Up to 15 months
Secondary outcomes (9)
Feasibility of treatment (number of cycles of maintenance)
Number of cycles of maintenance (median)
Measured: 84 days on average
Progression free survival
Measured: up to 7 months
response and stabilisation duration
Measured: up to 7 months
Number of patient with at least one adverse event
Measured: up to 7 months
Treatment duration
Measured: Up to 7 months
2nd line response rate
Measured: Up to 4 months
Number of adverse events
Measured: Up to 7 months
2nd line overall survival
Measured: Up to 7 months
2nd line progression free survival
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study start16 May 2013
- Primary completion20 Aug 2018
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung Cancer (Squamous or Non Squamous)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 632 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intergroupe Francophone de Cancerologie Thoracique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01850303
- Sponsor's protocol ID
- IFCT-1201
- Acronym
- MODEL
- Status last verified
- Mar 2023
- First submitted
- 29 Apr 2013
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.
PubMed 21831418Quoix E, Audigier-Valette C, Lavole A, Molinier O, Westeel V, Barlesi F, Le Treut J, Pichon E, Dauba J, Otto J, Moreau L, Madelaine J, Dumont P, Margery J, Debieuvre D, Renault PA, Pujol JL, Langlais A, Morin F, Moro-Sibilot D, Souquet PJ. Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial. Eur J Cancer. 2020 Oct;138:193-201. doi: 10.1016/j.ejca.2020.07.034. Epub 2020 Sep 6.
PubMed 32898792
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study Comparing Maintenance With Pemetrexed or Gemcitabine to a Surveillance in Elderly Patients (70 Years Old and More) With a Advanced Non Small Cell Lung Cancer Controlled by Induction Chemotherapy.
- ClinicalTrials.gov ID
- NCT01850303
- Acronym / sponsor ID
- MODEL / IFCT-1201
- Keywords
- Elderly, lung cancer, switch, maintenance, Elderly patients (between 70 and 89 years), NSCLC, IFCT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 632 participants (actual)
- Lead sponsor
- Intergroupe Francophone de Cancerologie ThoraciqueUniversity, hospital or other
- Study start
- 16 May 2013 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
For elderly patient, the treatment of Non Small Cell Lung Cancer was based on monotherapy but IFCT-0501 trial begun in 2006, demonstrated that a bitherapy (carboplatin and paclitaxel) is better than monotherapy in term of overall survival and progression free survival. The current recommendations are now to administer a carboplatin based bitherapy (4 or 6 cycles). After the treatment is stopped until progression and initiation of a second line treatment. The risk of this strategy is to be confronted to a rapid disease progression during the free interval. Indeed, about 1/3 of the patients whose disease was controlled after the chemotherapy do not receive 2nd line. The concept of maintenance is based on a continuous therapeutic pressure in order to preserve the therapeutic profit obtained by the treatment of 1st line (induction chemotherapy).
There is two types of maintenance :
- continuous maintenance therapy which consists in continuing the treatment initially associated with platinum until disease progression.
- switch maintenance which consists in introducing a new treatment after the end of induction chemotherapy The two types are validated by several trials. The marketing authorization of pemetrexed was enlarged to maintenance for non squamous carcinoma.
Gemcitabine has a good tolerance profile which make possible the use in a maintenance strategy. Several trials evaluated maintenance with this product and some show benefits in term of progression free survival.
The objective of this trial is to evaluate the switch maintenance in elderly patient with a controlled disease after 4 cycles of chemotherapy carboplatin-paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance | Other | Drug: Induction chemotherapy |
| Maintenance | Experimental | Drug: Pemetrexed, Drug: Gemcitabine, Drug: Induction chemotherapyPemetrexed for non squamous NSCLC Gemcitabine for squamous NSCLC |
Who may qualify
- Ages
- 70 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically documented Non Small Cell Lung Cancer non resectable or non irradiable stage III or stage IV
- EGFR wild type or non feasible EGFR
- 90 >Age ≥ 70
- ECOG Performance status : 0, 1 or 2
- Mini-Mental Test Status (MMS) > 23
Key exclusion criteria (6 listed)
- Mixed non-small cell and small cell tumors
- Patients with EGFR mutated tumor
- Patient with EML4-ALK translocation
- Evolutive or symptomatic metastasis of central nervous system
- Superior vena cava syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pemetrexed | Drug | Maintenance |
| Gemcitabine | Drug | Maintenance |
| Induction chemotherapy4 cycles of carboplatin-paclitaxel | Drug | Maintenance, Surveillance |
Primary outcome
Overall survival
Time frame: Up to 15 months
9 secondary outcomes
Feasibility of treatment (number of cycles of maintenance)
Time frame: 84 days on average
Progression free survival
Time frame: up to 7 months
response and stabilisation duration
Time frame: up to 7 months
Number of patient with at least one adverse event
Time frame: up to 7 months
Treatment duration
Time frame: Up to 7 months
2nd line response rate
Time frame: Up to 4 months
Number of adverse events
Time frame: Up to 7 months
2nd line overall survival
Time frame: Up to 7 months
2nd line progression free survival
Time frame: Up to 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Background: PubMed 21831418Quoix E, Zalcman G, Oster JP, Westeel V, Pichon E, Lavole A, Dauba J, Debieuvre D, Souquet PJ, Bigay-Game L, Dansin E, Poudenx M, Molinier O, Vaylet F, Moro-Sibilot D, Herman D, Bennouna J, Tredaniel J, Ducolone A, Lebitasy MP, Baudrin L, Laporte S, Milleron B; Intergroupe Francophone de Cancerologie Thoracique. Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial. Lancet. 2011 Sep 17;378(9796):1079-88. doi: 10.1016/S0140-6736(11)60780-0. Epub 2011 Aug 8.
- Results publication: PubMed 32898792Quoix E, Audigier-Valette C, Lavole A, Molinier O, Westeel V, Barlesi F, Le Treut J, Pichon E, Dauba J, Otto J, Moreau L, Madelaine J, Dumont P, Margery J, Debieuvre D, Renault PA, Pujol JL, Langlais A, Morin F, Moro-Sibilot D, Souquet PJ. Switch maintenance chemotherapy versus observation after carboplatin and weekly paclitaxel doublet chemotherapy in elderly patients with advanced non-small cell lung cancer: IFCT-1201 MODEL trial. Eur J Cancer. 2020 Oct;138:193-201. doi: 10.1016/j.ejca.2020.07.034. Epub 2020 Sep 6.
- IFCT official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pemetrexed, Gemcitabine and Induction chemotherapy in people with Non Small Cell Lung Cancer (Squamous or Non Squamous), run by Intergroupe Francophone de Cancerologie Thoracique at 78 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 5 inclusion and 6 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 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 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?
Overall survival (time frame: Up to 15 months). 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 NCT01850303, which also lists 2 linked publications.
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 14 Mar 2023.