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A Phase II Study of Velcade® (Bortezomib) in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Chemotherapy

Phase 2
18 Years
Not Enrolling

Thank you

Trial Information

A Phase II Study of Velcade® (Bortezomib) in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer (NSCLC) Who Have Not Received Prior Chemotherapy

Chemotherapy for non-small-cell lung cancer (NSCLC), mainly Cisplatin-based combinations,
provides a measurable but modest survival benefit for selected patients with advanced
disease. Advanced NSCLC remains largely fatal, with the positive impact of chemotherapy
limited by intrinsic and acquired resistance, manifested clinically by early progression and
transient responses. Current chemotherapy regimens have limited efficacy with a magnitude of
survival benefit that is still modest, and lead to significant toxicity, with many patients
unable to receive this kind of treatment, even in first line setting. There is, therefore, a
great need to provide patients with less toxic agents such as the novel targeted therapies,
with the potential to improve the efficacy and maintain a good quality of life. Bortezomib,
a proteasome inhibitor, has shown benefit as single agent in pretreated patients with
similar or lesser toxicity compared to chemotherapy. The current project is a phase II trial
that will include 46 patients with advanced NSCLC and without prior chemotherapy. An early
tumor assessment (after 6 weeks of therapy) will be performed, combined with regular
clinical and symptom assessment to allow for rapid and appropriate management of
non-responding patients, with cross over to another therapy as per the investigator and
patient choice. The primary objective is efficacy of bortezomib as determined by the rate of
no progression at 6 weeks. Secondary objectives are efficacy of bortezomib as determined by
objective response rate (incidence of CR and PR), disease control rate (CR, PR and
stabilization), duration of disease control, duration of objective response,
progression-free survival,overall survival, safety of bortezomib, rate of doublet therapy in
second line.

Inclusion Criteria:

- Histologically documented, inoperable, unresectable, incurable, locally advanced,
recurrent or metastatic (Stage IIIB or Stage IV) non-small cell lung cancer. (Note:
Histology is the preferred method of diagnosis. However, in case only cytology is
available, specimens from brushing, washing or needle aspiration etc. are acceptable
for diagnosis. Sputum cytology alone is not acceptable)

- No prior chemotherapy or therapy with systemic anti-tumour therapy (e.g., monoclonal
antibody therapy). Prior surgery and/or localized irradiation (palliative RT or
curative RT) is permitted. Pre operative or post operative anti neo-plastic therapy
is allowed if ended more than 2 years ago

- No prior exposure to agents directed at the HER axis (e.g. EGFR TK Inhibitors,

- Measurable disease as defined by RECIST criteria (attachment 1)

- Age 18 or greater

- ECOG performance status of 0 - 2 (attachment 2)

- Life expectancy of at least 12 weeks

- At least 4 weeks since any prior surgery or radiotherapy. Patients who, in the
opinion of the investigator, have fully recovered from surgery in less than 4 weeks
may also be considered for the study. Patients must have recovered (CTC < 1) from
acute toxicities of any previous therapy

- Granulocyte count > 1.5 x 109/L, platelet count > 100 x 109/L and hemoglobin >8.0

- Serum bilirubin must be < 1.5 upper limit of normal (ULN) or ≤ 5 times ULN in
patients with liver metastases. SGOT (AST) and SGPT (ALT) must be < 3 x ULN.

- Serum creatinine < 1.5 ULN or creatinine clearance > 60 ml/min

- Normal serum calcium

- Able to comply with study and follow-up procedures

- For all females of childbearing potential a negative pregnancy test must be obtained
within 48 hours before registration starting therapy

- Patients with reproductive potential must use effective contraception

- Written (signed) Informed Consent to participate in the study.

Exclusion Criteria:

- Any unstable systemic disease [including active infection, uncontrolled hypertension,
unstable angina, New York Heart Association (NYHA) Class III or IV heart failure
(Attachment 3, NYHA Classification of Cardiac Disease), myocardial infarction within
the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal or
metabolic disease] or Serious medical or psychiatric illness likely to interfere with
participation in this clinical study

- Any other malignancies within 5 years (except for adequately treated carcinoma in
situ of the cervix or basal or squamous cell skin cancer)

- Patients are excluded if they have brain metastasis or spinal cord compression that
is newly diagnosed and/or has not yet been definitively treated with surgery and/or
radiation; previously diagnosed and treated CNS metastases or spinal cord compression
with evidence of stable disease (clinically stable imaging) for at least 2 months is

- Any diseases, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of the study drug or that might affect the interpretation of
the results or render the subject at high risk from treatment complications

- Nursing mothers

- Has known or suspected hypersensitivity or intolerance to boron, mannitol, or
heparin, if an indwelling catheter is used

- Neuropathy ³ Grade 2

Type of Study:


Study Design:

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

Outcome Measure:

Efficacy of VELCADE as determined by the rate of no progression at 6 weeks

Principal Investigator

Jean-Charles SORIA, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

June 2006

Completion Date:

December 2007

Related Keywords:

  • Stage IIIB or IV Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms