New combo therapy for lung cancer passes first safety test
NCT ID NCT01167530
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This early-phase trial tested the drug everolimus (RAD001) alongside radiation therapy in 26 people with advanced non-small cell lung cancer that could not be surgically removed. The goal was to find a safe dose and check for side effects. Participants received everolimus weekly or daily before, during, and after radiation, followed by chemotherapy. The study focused on toxicity, not yet on whether the combination improves survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- everolimus (RAD001)
- What this could lead to
- If successful, this could point toward a safer way to combine targeted therapy with radiation for advanced lung cancer.
- What could go wrong
- This is a very early phase 1 trial with only 26 participants, focused on safety and dosing. It is not designed to prove the treatment works, and side effects may be significant.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
26 people
The number who actually took part.
- Started
-
Feb 2008
- Finished
-
Feb 2017
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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,
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Institut Gustave Roussy
Villejuif, 94800, France
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