Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
1 other identifier
interventional
106
1 country
38
Brief Summary
Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2010
Longer than P75 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 10, 2010
CompletedFirst Posted
Study publicly available on registry
April 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
February 16, 2021
CompletedFebruary 16, 2021
January 1, 2021
3.8 years
April 10, 2010
January 6, 2021
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-Control Rate
percentage of patients with disease control (complete response + partial response + stable disease) according to RECIST 1.1 criteria Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for Progressive Disease (at least a 20% increase in the sum of diameters of target lesions).
16 weeks after inclusion
Secondary Outcomes (2)
18-month Overall Survival Rate
18 months
Progression Free Survival
52.3 months (median duration of follow-up)
Study Arms (1)
A
EXPERIMENTALChemoradiotherapy
Interventions
Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
Eligibility Criteria
You may qualify if:
- non-squamous stage III non-small cell lung cancer
- measurable disease (RECIST 1.1)
- ECOG performance status 0-1
- normal organ and marrow function
You may not qualify if:
- prior chest radiation therapy
- history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma in situ of the cervix) within the last five years.
- Prior therapy with known specific inhibitors of the EGFR.
- history of severe allergic reaction to prior therapy with monoclonal antibodies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
Clinique de l'Europe
Amiens, France
Centre Hospitalier
Annemasse, France
CHU Besancon - Pneumologie
Besançon, 25000, France
Bordeaux - Polyclinique Nord
Bordeaux, 33300, France
Caen - Centre François Baclesse
Caen, 14000, France
Caen - CHU Côte de Nacre
Caen, 14000, France
CH
Chartres, France
CH
Cholet, France
CHU
Clermont-Ferrand, France
CH
Colmar, France
Clinique des Cèdres
Cornebarrieu, France
Dijon - CAC
Dijon, 21000, France
CHU Grenoble
Grenoble, 38000, France
Institut d'Oncologie Hartmann
Levallois-Perret, France
CHU (Hôpital Calmette) - Pneumologie
Lille, 59000, France
CH
Longjumeau, France
Clinique des 4 Pavillons
Lormont, France
Hôpital Louis Pradel
Lyon, France
Hôpital Nord
Marseille, France
Centre Hospitalier
Montélimar, France
CHU
Nancy, France
CH
Nevers, France
Centre Hospitalier
Niort, France
APHP - Hopital Tenon - Pneumologie
Paris, 75020, France
Hôpital du Val de Grâce
Paris, France
Hôpital Saint-Joseph
Paris, France
Perpignan - Centre Catalan d'Oncologie
Perpignan, 66000, France
HCL - Lyon Sud
Pierre-Bénite, 69495, France
CHU
Poitiers, France
Centre Hospitalier
Rambouillet, France
Reims - CHU
Reims, 51092, France
Institut Jean Godinot
Reims, France
Centre Frederic Joliot
Rouen, France
Centre Etienne Dolet
Saint-Nazaire, France
Hôpitaux Universitaires - Nouvel Hôpital Civil
Strasbourg, 63000, France
Suresnes - Hopital Foch
Suresnes, 92151, France
Tours - CHU
Tours, 37000, France
Institut Gustave Roussy
Villejuif, 94800, France
Related Publications (2)
Auperin A, Le Pechoux C, Rolland E, Curran WJ, Furuse K, Fournel P, Belderbos J, Clamon G, Ulutin HC, Paulus R, Yamanaka T, Bozonnat MC, Uitterhoeve A, Wang X, Stewart L, Arriagada R, Burdett S, Pignon JP. Meta-analysis of concomitant versus sequential radiochemotherapy in locally advanced non-small-cell lung cancer. J Clin Oncol. 2010 May 1;28(13):2181-90. doi: 10.1200/JCO.2009.26.2543. Epub 2010 Mar 29.
PMID: 20351327BACKGROUNDTredaniel J, Mornex F, Barillot I, Diaz O, Hennequin C, Le Pechoux C, Lavole A, Giraud P, Souquet PJ, Teixeira L, Vaylet F, Zalcman G, Baudrin L, Morin F, Milleron B. [A phase II study of cetuximab, pemetrexed, cisplatin, and concurrent radiotherapy in patients with locally advanced, unresectable, stage III, non squamous, non-small cell lung cancer (NSCLC)]. Rev Mal Respir. 2011 Jan;28(1):51-7. doi: 10.1016/j.rmr.2010.06.027. Epub 2011 Jan 11. French.
PMID: 21277474BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Non randomized study
Results Point of Contact
- Title
- Communications Officer
- Organization
- IFCT
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Trédaniel, MD, PhD
IFCT, GH Paris Saint-Joseph
- PRINCIPAL INVESTIGATOR
Françoise Mornex, MD, PhD
IFCT, HCL Lyon-Sud
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2010
First Posted
April 13, 2010
Study Start
March 1, 2010
Primary Completion
January 1, 2014
Study Completion
December 1, 2015
Last Updated
February 16, 2021
Results First Posted
February 16, 2021
Record last verified: 2021-01