Study to Evaluate RAD001 in Combination With Radiotherapy in Non-small Cell Lung Cancer (RAD001)

The phase 1 study evaluats RAD001 in combination with radiotherapy in non-small cell lung cancer.

First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of the study:RAD001 (everolimus) will be administered per os every day one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be conducted independently and in parallel.Radiotherapy: 66 Grays over 6.5 weeks. (5 weekly fractions of 2 Grays)Chemotherapy: 2 cycles: Cisplatin 100 mg/m2 D1, Navelbine 25 mg/m2 D1, D8, every 21 days.

Study Overview

• Status: Completed
• Conditions: Non-small Cell Lung Cancer; Locally Advanced Disease
• Intervention / Treatment: Drug: Everolimus

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Villejuif, France, 94800
    • Institut Gustave Roussy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 resection)
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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Toxicity	Dose limiting toxicity	Eleven week

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free and overall survival.	Three years
Response rate	Four months

Collaborators and Investigators

• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Collaborators: Novartis

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2008
• Primary Completion (Actual): July 4, 2013
• Study Completion (Actual): February 9, 2017

Study Registration Dates

• First Submitted: July 21, 2010
• First Submitted That Met QC Criteria: July 21, 2010
• First Posted (Estimated): July 22, 2010

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Radiotherapy; Everolimus; Chemotherapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung; Organic Chemicals; Macrolides; Lactones; Sirolimus; Everolimus
• Other Study ID Numbers: IGR 1269