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A Randomized Phase 2 Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung, Adenocarcinoma, Carcinoma, Large Cell, Carcinoma, Squamous Cell

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Trial Information

A Randomized Phase 2 Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage III/IV Non-Small Cell Lung Cancer Patients

This is a Phase 2, open-label, randomized, multicenter study of maintenance temozolomide
versus observation in subjects with stable or responding stage III/IV NSCLC to be conducted
in conformance with Good Clinical Practices. Subjects will be randomly assigned to a study
drug (temozolomide) or observation arm. The study drug will be administered at a dose of 75
mg/m^2 PO daily for 21 consecutive days, followed by a 7-day rest period, until progression
or up to a maximum of 6 cycles, whichever occurs first. Subjects completing 6 cycles of
treatment will be followed up for incidence of brain metastasis for up to 2 years, or until

Inclusion Criteria:

- Adult subjects (age >=18 years), of either sex, and of any race.

- Subjects must have stage IV or III with pleural and/or pericardial effusion
histologically confirmed NSCLC.

- Subjects must have completed 2-6 cycles of a standard systemic therapy, with or
without radiation therapy, consisting of at least 2 anti-tumor agents as first-line
treatment for Stage III/IV disease, and have documented complete response (CR),
partial response (PR), or stable disease (SD) per Response Evaluation Criteria in
Solid Tumors (RECIST).

- Response must be confirmed within 4-8 weeks of completing first-line chemotherapy.
Study treatment must begin within 12 weeks of completing first-line chemotherapy.

- Female subjects of childbearing potential or male subjects with female partner of
childbearing potential must agree to use a medically accepted method of contraception
or be surgically sterilized prior to Screening, while receiving study drug, and for
30 days after stopping study drug. Female subjects of childbearing potential must
have a negative pregnancy test confirmed prior to dosing with study drug.

- Subjects must be free of any clinically relevant disease (other than stage III/IV
NSCLC) that would, in the principal investigator and/or Sponsor's opinion, interfere
with the conduct of the study or study evaluations.

- Subjects must be able to adhere to the dosing and visit schedules, and agree to
report medication taken, concomitant medications, and adverse events (AEs).

- Eastern Cooperative Oncology Group (ECOG) performance status <=2.

- Clinical laboratory tests (complete blood count [CBC], serum chemistries) must be
obtained within 14 days prior to randomization and meet specified criteria.

Exclusion Criteria:

- Brain metastases documented on post-chemotherapy magnetic resonance imaging (MRI).

- Documented history of brain metastases.

- Subject has received more than one prior anti-tumor regimen for Stage III/IV disease.
"Regimen" refers to single drug or planned combination of two or more anti-tumor
therapies. Bevacizumab (AvastinĀ®) as part of a planned sequence of therapy after
first-line platinum-containing double regimen is not considered a second regimen.
Neo-adjuvant treatment for resectable subjects is not considered a second regimen.

- Subject has used any investigational product within 4 weeks prior to enrollment.

- Subject is currently receiving immunotherapy or chemotherapy, cytotoxic or targeted
therapy as treatment for active systemic disease. Bevacizumab (AvastinĀ®) as part of
the prescribed standard first-line regimen is allowed.

- Female who is pregnant, or intends to become pregnant, during the study.

- Subject is in a situation or condition that, in the opinion of the investigator, may
interfere with optimal participation in the study.

- Subject is currently participating in any other clinical study, with the exception of
observational long-term follow-up.

- Subject is allergic to, or has sensitivity to, the study drug or its excipients.

- Documented symptomatic, progressive or new bone metastases following the first-line
chemotherapy with or without radiation therapy (biphosphonate use for prophylaxis or
as a maintenance therapy is allowed).

- No prior malignancy except for adequately treated basal cell or squamous cell skin
cancer, in situ cervical cancer, or other cancer for which the subject has been
disease-free for 5 years.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Had Brain Metastases

Outcome Description:

Brain Metastases were defined as radiological evidence of brain metastases on magnetic resonance imaging (MRI).

Outcome Time Frame:

Up to 12 months (as measured from day 1 of cycle 1 of standard first-line systemic chemotherapy)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

January 2011

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Adenocarcinoma
  • Carcinoma, Large Cell
  • Carcinoma, Squamous Cell
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Squamous Cell
  • Lung Neoplasms
  • Carcinoma, Large Cell