Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
TARSEQ
Randomized Open Non Comparative Multicenter Phase II Study of Sequential Erlotinib With Docetaxel Versus Docetaxel Alone in Second Line of Treatment in Patients With Non Small Cell Lung Cancer After Failure of First Line Chemotherapy
1 other identifier
interventional
156
1 country
30
Brief Summary
This 2 arms study will compare the efficacy and safety of treatment with sequential erlotinib plus docetaxel therapy versus docetaxel alone as second line treatment in patients with recurrent non-small cell lung cancer. Patients will be randomized to receive in group 1(experimental arm): docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 and group 2 (control arm): docetaxel :75 mg/m² IV day 1 every 3 weeks. The anticipated time on study treatment is until disease progression. Target sample size is 156. The main of this study is to determine the relevance of the association sequential erlotinib and docetaxel in terms of progression-free survival .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2011
30 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
First Submitted
Initial submission to the registry
May 9, 2011
CompletedFirst Posted
Study publicly available on registry
May 10, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedResults Posted
Study results publicly available
May 15, 2026
CompletedMay 15, 2026
April 1, 2015
1.8 years
May 9, 2011
March 11, 2026
April 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival at 15 Weeks.
at 15 weeks
Secondary Outcomes (3)
Survival Rate at 12 Months
12 months
Overall Survival
12 mois
Progression-free Survival
12 months
Study Arms (2)
Docetaxel
ACTIVE COMPARATORErlotinib
EXPERIMENTALInterventions
docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
Eligibility Criteria
You may qualify if:
- Histologically proven NSCLC (
- Mutational status of EGFR : wild type or unknown
- Stage IV disease with cytologic or histologic documentation in patients with a single easily accessible metastasis or metastatic relapses in a non irradiated region from a primary tumor treated with surgery or radiotherapy (with cytologic or histologic documentation of relapse)
- Presence of at least one measurable target lesion (one dimension) in a non irradiated region (at least 10 mm on spiral computed tomography).
- Age ≥ 18 years
- Performance status 0,1,2 exception : age \> 74 years only PS 0 or 1
- Normal hepatic function
- Normal renal function
- Normal calcemia
- Normal haematological function
- Life expectancy \> 12 weeks.
- Women of child bearing potential must use effective contraception.
- Men might be surgically sterile or accept to use an effective contraceptive procedure during and until 6 months after the treatment.
- Written informed consent to participate in the study.
You may not qualify if:
- PS \> 2, exception : age \> 74 years only PS ≥ 2
- Presence of another cancer
- Previous treatment with an anti egfr agent or docetaxel
- QT prolongation (\>470 ms)
- Uncontrolled arterial hypertension.
- Concurrent radiotherapy, except for palliative bone irradiation.
- Stroke less than 6 months before study entry.
- Psychiatric or neurological disorders preventing the patient from understanding the nature of the trial
- Uncontrolled infection.
- Caval syndrome
- Malabsorption syndrome
- Allergy to erlotinib or one of its constituents
- Allergy to docetaxel or one of its constituents
- Pregnancy and breast-feeding
- Surgery less than two months before study entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Limogeslead
- Hoffmann-La Rochecollaborator
Study Sites (30)
Service de Pneumologie, CHU Angers
Angers, 49033, France
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, 74011, France
Service de Pneumologie; Centre Hospitalier
Beauvais, 60 021, France
Service de Pneumologie
Beauvais, France
Service de Pneumologie
Bordeaux, France
CHU Brest
Brest, France
Service de Pneumologie
Charleville Mezière, France
Service de Pneumologie ; Centre hospitalier
Charleville-Mézières, 08 000, France
Service de Pneumologie
Créteil, France
Service de Pneumologie; Centre Hospitalier
Draguignan, 83300, France
Service de Pneumologie
Draguignan, France
Service de Pneumologie
Elbeuf, France
Service de Pneumologie
Gap, France
Département de Pathologie Respiratoire du CHU de Limoges
Limoges, France
Service de Pneumologie, Hôpital de la Croix Rousse
Lyon, France
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay
Mantes-la-Jolie, 78200, France
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite
Marseille, 13274, France
CH de Meaux
Meaux, France
Service de Pneumologie
Meaux, France
Service de Pneumologie
Mulhouse, France
Service de Pneumologie - Hôpital St Antoine, Paris
Paris, 75571, France
Service de Pneumologie-Allergologie; Centre Hospitalier Général
Périgueux, 24019, France
CHU Reims
Reims, France
Service de Pneumologie, Hôpital Pontchailloux
Rennes, France
Service de Pneumologie; CHG de Roanne
Roanne, 42300, France
Clinique Pneumologique; Hôpital Charles Nicolle
Rouen, 76031, France
Service de Pneumologie; Hôpital Bois Guillaume
Rouen, 76233, France
Hôpital Charles Nicolle, Service de Pneumologie
Rouen, France
Service de Pneumologie, Hôpital Nord
Saint-Etienne, France
Service de Pneumologie
Villefranche, France
Related Publications (1)
Auliac JB, Chouaid C, Greillier L, Monnet I, Le Caer H, Falchero L, Corre R, Descourt R, Bota S, Berard H, Schott R, Bizieux A, Fournel P, Labrunie A, Marin B, Vergnenegre A; GFPC team. Randomized open-label non-comparative multicenter phase II trial of sequential erlotinib and docetaxel versus docetaxel alone in patients with non-small-cell lung cancer after failure of first-line chemotherapy: GFPC 10.02 study. Lung Cancer. 2014 Sep;85(3):415-9. doi: 10.1016/j.lungcan.2014.07.006. Epub 2014 Jul 17.
PMID: 25082565RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr J.B. Auliac
- Organization
- Quesnay Hospital,
Study Officials
- STUDY CHAIR
Alain Vergnengre, MD
University Hospital, Limoges
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 9, 2011
First Posted
May 10, 2011
Study Start
June 1, 2011
Primary Completion
March 1, 2013
Study Completion
January 1, 2014
Last Updated
May 15, 2026
Results First Posted
May 15, 2026
Record last verified: 2015-04