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New combo therapy for lung cancer passes first safety test

NCT ID NCT01167530

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.