Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

Study summary

This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedEverolimus

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 21, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?Novartis Pharmaceuticals

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Novartis Pharmaceuticals
Interventions being studied: Drug: Everolimus

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Small cell lung cancer (SCLC)→

Treatment approach

Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
Age ≥ 18 years
WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
Adequate bone marrow, liver and renal function

Reasons someone may not be able to joinExclusion criteria

Chronic steroid treatment
Prior treatment with chemotherapy for advanced lung cancer
Prior treatment with mTOR inhibitors
Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
Symptomatic or uncontrolled brain metastases
Other cancers within the past 5 years
Pregnant or breastfeeding women Other protocol-defined inclusion/

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Highlands Oncology GroupFayetteville, Arkansas
University of Colorado Health Sciences CenterAurora, Colorado
Dana Faber Cancer InstituteBoston, Massachusetts
MD Anderson Cancer CenterHouston, Texas
Cancer Therapy and Research Center at UTHSCSASan Antonio, Texas
Novartis Investigative SiteParis

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 21, 2020. Always confirm current availability with the study team.

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