Non Small Cell Lung CancerPhase 2TARSEQNCT01350817
Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
A Phase 2 study testing Erlotinib + docetaxel and Docetaxel in people with Non Small Cell Lung Cancer, run by University Hospital, Limoges at 30 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Erlotinib + docetaxel and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 30 sitesFrance
- Study dates
- Jun 2011to Jan 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
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- 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.
Who cannot join
- 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.
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- 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
- Other organic disorders preventing inclusion in the trial
- 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
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
France30 sites
Service de Pneumologie, CHU Angers
Angers, 49033
Service de pneumologie; Centre Hospitalier d'Annecy
Annecy, 74011
Service de Pneumologie; Centre Hospitalier
Beauvais, 60 021
Service de Pneumologie
Beauvais
Service de Pneumologie
Bordeaux
CHU Brest
Brest
Service de Pneumologie
Charleville Mezière
Service de Pneumologie ; Centre hospitalier
Charleville-Mézières, 08 000
Service de Pneumologie
Créteil
Service de Pneumologie; Centre Hospitalier
Draguignan, 83300
Service de Pneumologie
Draguignan
Service de Pneumologie
Elbeuf
Service de Pneumologie
Gap
Département de Pathologie Respiratoire du CHU de Limoges
Limoges
Service de Pneumologie, Hôpital de la Croix Rousse
Lyon
Service de Pneumologie-Neurologie ; Centre Hospitalier F. Quesnay
Mantes-la-Jolie, 78200
Département des Maladies Respiratoires ; Hôpital Sainte Marguerite
Marseille, 13274
CH de Meaux
Meaux
Service de Pneumologie
Meaux
Service de Pneumologie
Mulhouse
Service de Pneumologie - Hôpital St Antoine, Paris
Paris, 75571
Service de Pneumologie-Allergologie; Centre Hospitalier Général
Périgueux, 24019
CHU Reims
Reims
Service de Pneumologie, Hôpital Pontchailloux
Rennes
Service de Pneumologie; CHG de Roanne
Roanne, 42300
Clinique Pneumologique; Hôpital Charles Nicolle
Rouen, 76031
Service de Pneumologie; Hôpital Bois Guillaume
Rouen, 76233
Hôpital Charles Nicolle, Service de Pneumologie
Rouen
Service de Pneumologie, Hôpital Nord
Saint-Etienne
Service de Pneumologie
Villefranche
About this study
Official title: 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
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 .
Read the detailed description
In this study, the patient will be randomized 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.
Assessment during treatment: Physical examination, ECG,: every 3 weeks, laboratory tests: weekly, every 3 weeks pulmonary X-ray .The CT scans:. Measurable targets are assessed by RECIST compared to the beginning of treatment: at 6 weeks (day 42 EVA 2), 12 weeks (D84 EVA 3), 15 weeks (D105 EVA 4: Evaluation of the SSP) and then every 6 weeks until progression.
Quality of life will be assessed Day 42 then every 6 weeks during chemotherapy, Tolerability will be assessed at each visit based on CTC v4.0 criteria.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Erlotinib + docetaxel, Docetaxel
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib + docetaxelDrug
docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
DocetaxelDrug
docetaxel :75 mg/m² IV day 1 every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
| Erlotinib | Experimental | Not described Receives: Drug: Erlotinib + docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival at 15 Weeks.
Measured: at 15 weeks
Secondary outcomes (3)
Survival Rate at 12 Months
Measured: 12 months
Overall Survival
Measured: 12 mois
Progression-free Survival
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startJun 2011
- Primary completionMar 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Alain Vergnengre, MD, Study chair, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350817
- Sponsor's protocol ID
- I10004
- Other IDs
- 2010-024592-77
- Acronym
- TARSEQ
- Status last verified
- Apr 2015
- First submitted
- 9 May 2011
- Last updated
- 21 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25082565
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01350817
- Acronym / sponsor ID
- TARSEQ / I10004
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Jun 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 May 2011 (estimated)
- Results
- Posted 15 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
In this study, the patient will be randomized 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.
Assessment during treatment: Physical examination, ECG,: every 3 weeks, laboratory tests: weekly, every 3 weeks pulmonary X-ray .The CT scans:. Measurable targets are assessed by RECIST compared to the beginning of treatment: at 6 weeks (day 42 EVA 2), 12 weeks (D84 EVA 3), 15 weeks (D105 EVA 4: Evaluation of the SSP) and then every 6 weeks until progression.
Quality of life will be assessed Day 42 then every 6 weeks during chemotherapy, Tolerability will be assessed at each visit based on CTC v4.0 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: Docetaxel |
| Erlotinib | Experimental | Drug: Erlotinib + docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Erlotinib + docetaxeldocetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16 | Drug | Erlotinib |
| Docetaxeldocetaxel :75 mg/m² IV day 1 every 3 weeks. | Drug | Docetaxel |
Primary outcome
Progression Free Survival at 15 Weeks.
Time frame: at 15 weeks
3 secondary outcomes
Survival Rate at 12 Months
Time frame: 12 months
Overall Survival
Time frame: 12 mois
Progression-free Survival
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25082565Auliac 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.
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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.
Alain Vergnengre, MD study chair
University Hospital, Limoges
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib + docetaxel and Docetaxel in people with Non Small Cell Lung Cancer, run by University Hospital, Limoges at 30 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 14 inclusion and 16 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 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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?
Yes. Results are posted in the registry (first posted 15 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at 15 Weeks. (time frame: at 15 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 NCT01350817, 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 21 Sep 2026.