Phase 2
N=151
Erlotinib and Docetaxel in Second Line of Treatment in Patients With Non Small Cell Lung Cancer
Non Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01350817 ↗Enrolled (actual)
151
Serious AEs
91.8%
Results posted
May 2026
Primary outcome: Primary: Progression Free Survival at 15 Weeks. — 17; 18 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erlotinib + docetaxel (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Limoges
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival at 15 Weeks. |
17; 18 | — |
| SECONDARY Survival Rate at 12 Months |
37.8; 35.6 | — |
| SECONDARY Overall Survival |
8.3; 6.5 | — |
| SECONDARY Progression-free Survival |
2.5; 2.2 | — |
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 .
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT01350817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.