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A Phase I Dose Escalation Study of RAD001 in Combination With Chemotherapy and Radiation in Patients With NSCLC

Phase 1
18 Years
89 Years
Not Enrolling
Non-Small Cell Lung Cancer

Thank you

Trial Information

A Phase I Dose Escalation Study of RAD001 in Combination With Chemotherapy and Radiation in Patients With NSCLC

In oncology, clinical experience with RAD001 has been based on a number of phase I and II
studies with single agent RAD001 as well as phase Ib and II studies of RAD001 in combination
with other chemotherapeutic and molecular targeted agents, including paclitaxel,
gemcitabine, and erlotinib among others. More recently, a phase III trial of single agent
RAD001 in patients with metastatic renal cell carcinoma who had failed therapy with VEGF
tyrosine kinase inhibitors was completed. Clinical experience for indications other than
oncology comes from single dose studies in healthy volunteers, and studies in solid organ
transplant patients, where RAD001 was administered with other immunosuppressive agents.

Inclusion Criteria:

- Histologically or cytologically confirmed NSCLC of any type

- Disease stage. Patients with unresectable stage II, stage III, and Mx are eligible.
This includes patients who are being considered as surgical candidates after
induction chemoradiation. Patients with Mx or M1 disease whose life-span and
prognosis are felt to be dominated by the locoregional disease in the chest and are
candidates for chemoradiotherapy are also eligible.

- Patients with pleural effusion that is transudative, cytologically negative and non-
bloody are eligible if the radiation oncologist feels that the tumor can be
encompassed within a reasonable field of radiotherapy.

- If a pleural effusion is of such a small size that a thoracentesis is not possible,
then the patient is eligible

- Patients with malignant pleural or pericardial effusions are not eligible

- Patients will be eligible with or without measurable or evaluable disease. Patients
with both measurable and evaluable disease will be evaluated for criteria for
measurable disease

- Measurable disease is defined according to RECIST criteria

- Evaluable disease is defined as lesions apparent on CT which do not fit criteria for

- Ill defined masses associated with post obstructive changes

- Mediastinal or hilar adenopathy measurable in only one dimension

- Age ≥ 18 years

- ECOG performance status ≤ 2

- Life expectancy > 6 months

- Adequate lung function as defined by an 02 saturation that is ≥ 90% on room air

- Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x
109/L, Hb >9 g/dL Adequate liver function as shown by: serum bilirubin ≤ 1.5 x ULN,
ALT and AST ≤ 2.5x ULN (≤ 5x ULN in patients with liver metastases), INR and PTT
≤1.5. (Anticoagulation is allowed if target INR ≤ 1.5 on a stable dose of warfarin or
on a stable dose of LMW heparin for >2 weeks at time of randomization.)

- Adequate renal function: serum creatinine ≤ 1.5 x ULN

- Fasting serum cholesterol ≤300 mg/dL OR ≤7.75 mmol/L AND fasting triglycerides ≤ 2.5
x ULN. NOTE: In case one or both of these thresholds are exceeded, the patient can
only be included after initiation of appropriate lipid lowering medication.

- Informed consent must be obtained from all patients prior to beginning therapy.
Patients should have the ability to understand and the willingness to sign a written
informed consent document.

- Radiation therapy requirements: Patient must have a completed treatment plan approved
by the protocol review team

Exclusion Criteria:

- Patients who have received prior radiation or chemotherapy for the current diagnosis
of NSCLC (patients who received surgery only for a prior NSCLC are eligible if the
current diagnosis is felt to represent a new primary, and the PFT's would allow for
concurrent chemoradiation)

- Patients, who have had a major surgery or significant traumatic injury within 4 weeks
of start of study drug, patients who have not recovered from the side effects of any
major surgery (defined as requiring general anesthesia) or patients that may require
major surgery during the course of the study

- Prior treatment with any investigational drug within the preceding 4 weeks

- Patients receiving chronic, systemic treatment with corticosteroids or another
immunosuppressive agent. Topical or inhaled corticosteroids are allowed.

- Patients should not receive immunization with attenuated live vaccines within one
week of study entry or during study period

- Other malignancies within the past 3 years except for adequately treated carcinoma of
the cervix, basal or squamous cell carcinomas of the skin, or breast DCIS, who may be
included if the diagnosis was within 3 years.

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study such as:

- unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction
within 6 months of start of study drug

- serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac

- symptomatic congestive heart failure of New York heart Association Class III or IV

- uncontrolled diabetes as defined by fasting serum glucose >1.5 x ULN

- active (acute or chronic) or uncontrolled severe infections

- liver disease such as cirrhosis, chronic active hepatitis or chronic persistent

- A known history of HIV seropositivity

- Impairment of gastrointestinal function or gastrointestinal disease that may
significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled
nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)

- Patients with an active, bleeding diathesis

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the maximum tolerated dose (MTD) and dose limiting toxicities (DLT) of RAD001 when administered in combination with chemotherapy and radiation.

Outcome Time Frame:


Safety Issue:


Principal Investigator

Everett E Vokes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Chicago


United States: Institutional Review Board

Study ID:




Start Date:

February 2010

Completion Date:

January 2012

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-Small Cell
  • Lung Cancer
  • Unresectable advanced NSCLC
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



University of Chicago Medical Center Chicago, Illinois  60637