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Phase 1
18 Years
Open (Enrolling)
Non-small Cell Lung Cancer, Locally Advanced Disease

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Trial Information

Inclusion Criteria:

1. Unresectable non-small cell lung cancer, stage IIIA/B, or stage IV for which the
primary tumor is symptomatic (cough, dyspnea, pain) without extra-thoracic lesions
rapidly evolving for which patients should receive radiotherapy at curative dose

2. Measurable lesion, documented histologically, potentially accessible during
fiberoptic bronchoscopy.

3. Age > 18 years, WHO 0-1,

4. Neutrophil count > 1500 /mm3, Hemoglobin > 9 g/dL, Platelet count > 100,000/mm3

5. Bilirubin < 1.5 mg/dL, Transaminases < 3 N, albumin >30 g / L, PT > 70%

6. Creatinine < 120 μM/L

7. Patient information and informed consent form signed.

8. No previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).

Exclusion Criteria:

1. Patients previously treated with RAD001 (everolimus) or any other mTOR inhibitor

2. Stage IV for which the primary tumor is not symptomatic with extra-thoracic lesions
rapidly evolving requiring systemic treatment

3. Previous radiotherapy,

4. Venous or arterial thrombosis, pulmonary embolism during the previous six months

5. Concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent,
history of epilepsy

6. Concomitant treatment with medicinal products that inhibit, induce or are substrates
for CYP3A4(inhibitors: atazanavir, clarithromycin, indinavir, itraconazole,
ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin,
amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir,
verapamil, ciclosporin, voriconazoleinducers: rifampicin, carbamazepine,
rifabutinsubstrates: midazolam, buspirone, felodipine)

7. Concomitant therapy with agents otherwise used in the treatment of cancer (for
example methotrexate for rheumatoid arthritis).

8. Chronic treatment with corticosteroids or another immunosuppressant

9. Patients with an active bleeding diathesis or taking an oral vitamin K antagonist
(except low-dose Coumadin (warfarin sodium))

10. Other concurrent severe and/or uncontrolled disease which could compromise
participation in the study (i.e. uncontrolled diabetes, uncontrolled hypertension,
severe infection, severe malnutrition, unstable angina, or congestive heart failure -
New York Heart Association Class III or IV, ventricular arrhythmia, active ischemic
heart disease, myocardial infarction during the previous six months, chronic liver or
renal disease, active upper GI tract ulceration)

11. Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001 (EVEROLIMUS) (i.e. ulcerative disease,
uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel

12. HIV seropositivity

13. Patient with a virological test positive to hepatitis B (HBs positive)

14. Patients with active cutaneous, mucosal, ocular or gastrointestinal disorders of
grade > 1

15. Previous cancer (except basal cell skin cancer or cervical carcinoma in situ) during
the 3 years prior to entering the trial.

16. important pulmonary fibrosis on X-ray

17. Women who are or could become pregnant or who are currently breastfeeding,

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

Dose limiting toxicity

Outcome Time Frame:

Eleven week

Safety Issue:



France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IGR 1269



Start Date:

March 2008

Completion Date:

July 2014

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Locally Advanced Disease
  • Everolimus
  • Radiotherapy
  • Chemotherapy
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms