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

A Phase Ib Study Investigating the Combination of RAD001 With Cisplatin and Etoposide in Patients With Extensive-stage Small-cell Lung Cancer Not Previously Treated With Chemotherapy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00466466

Enrollment

Registered

2007-04-27

Start date

2007-04-30

Completion date

Unknown

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small-Cell Lung Cancer

Keywords

Small-Cell Lung Cancer, SCLC, Advanced Lung Cancer, RAD, RAD001, Chemotherapy, Cisplatin, Etoposide

Brief 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.

Interventions

DRUGEverolimus

RAD001 will be supplied by Novartis as tablets in 3 different dosage strengths, 2.5, 5 and 10 mg. The drug will be packaged in blisters containing 10 tablets per blister. Blisters and packaging will be compliant with local regulations and be printed in local language.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Exclusion 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/

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicity (DLT) rate will be measured at End-of-Cycle 1	Day 21

Secondary

Measure	Time frame
Overall tumor response	Every 6-8 weeks
Relative dose intensity (RDI) of carboplatin and paclitaxel will be evaluated upon completion of the dose escalation within each regimen	within 6 cycles (Day 126)
PK parameters derived from the PK profile of treatment drugs when administered alone or in combination will be evaluated during the first 6 cycles	During the first 6 cycles

Countries

France, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026