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

August 13, 2026 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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

Intervention / Treatment

Drug: Everolimus

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Villejuif, France, 94800
    - Institut Gustave Roussy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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
Measurable lesion, documented histologically, potentially accessible during fiberoptic bronchoscopy.
Age > 18 years, WHO 0-1,
Neutrophil count > 1500 /mm3, Hemoglobin > 9 g/dL, Platelet count > 100,000/mm3
Bilirubin < 1.5 mg/dL, Transaminases < 3 N, albumin >30 g / L, PT > 70%
Creatinine < 120 μM/L
Patient information and informed consent form signed.
No previous treatment for lung cancer (surgery, radiotherapy, chemotherapy).

Exclusion Criteria:

Patients previously treated with RAD001 (everolimus) or any other mTOR inhibitor
Stage IV for which the primary tumor is not symptomatic with extra-thoracic lesions rapidly evolving requiring systemic treatment
Previous radiotherapy,
Venous or arterial thrombosis, pulmonary embolism during the previous six months
Concomitant treatment with phenytoin, phenobarbital or any other antiepileptic agent, history of epilepsy
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)
Concomitant therapy with agents otherwise used in the treatment of cancer (for example methotrexate for rheumatoid arthritis).
Chronic treatment with corticosteroids or another immunosuppressant
Patients with an active bleeding diathesis or taking an oral vitamin K antagonist (except low-dose Coumadin (warfarin sodium))
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)
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)
HIV seropositivity
Patient with a virological test positive to hepatitis B (HBs positive)
Patients with active cutaneous, mucosal, ocular or gastrointestinal disorders of grade > 1
Previous cancer (except basal cell skin cancer or cervical carcinoma in situ) during the 3 years prior to entering the trial.
important pulmonary fibrosis on X-ray
Women who are or could become pregnant or who are currently breastfeeding,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 Time Frame: Eleven week	Dose limiting toxicity	Eleven week

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Collaborators

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Deutsch E, Le Pechoux C, Faivre L, Rivera S, Tao Y, Pignon JP, Angokai M, Bahleda R, Deandreis D, Angevin E, Hennequin C, Besse B, Levy A, Soria JC. Phase I trial of everolimus in combination with thoracic radiotherapy in non-small-cell lung cancer. Ann Oncol. 2015 Jun;26(6):1223-1229. doi: 10.1093/annonc/mdv105. Epub 2015 Feb 20.

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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