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STAGE IIIB OR IV NON-SMALL CELL LUNG CANCERPhase 2NCT00346645

A Phase II Study of Velcade® in Patients Stage IIIB OR IV Non-Small Cell Lung Cancer

A Phase 2 study testing Bortezomid (VELCADE®) in people with STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine whether Bortezomib is effective in the treatment of patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen for advanced disease. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bortezomid (VELCADE®)
How many people
46 participants
Where
1 siteFrance
Study dates
Jun 2006to Dec 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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, Herceptin)
  • Measurable disease as defined by RECIST criteria (attachment 1)
  • Age 18 or greater
  • ECOG performance status of 0 - 2 (attachment 2)
Show all 16Show fewer
  • 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 g/dL
  • 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.

Who cannot join

  • 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 permitted
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Institut Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

Official title: 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

The purpose of this study is to determine whether Bortezomib is effective in the treatment of patients with non-small-cell lung cancer who have not received any prior chemotherapy regimen for advanced disease.

Read the detailed description

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.

Being tested
Bortezomid (VELCADE®)
Keywords
NON-SMALL CELL LUNG CANCER METASTATIC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bortezomid (VELCADE®)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (9)

  1. Efficacy of VELCADE as determined by

  2. Objective response rate (incidence of CR and PR)

  3. Disease control rate (CR, PR and stabilization)

  4. Duration of disease control

  5. Duration of objective response

  6. Progression-free survival (PFS)

  7. Overall survival (OS)

  8. Safety of VELCADE

  9. Rate of doublet therapy in second line

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jun 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionMay 2007
  4. Study completionDec 2007

Why it stopped: stopped after planned interim analysis for lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00346645
Sponsor's protocol ID
VELCADE
Other IDs
CSET 1192
Status last verified
Aug 2026
First submitted
29 Jun 2006
Last updated
19 Aug 2026
Results posted
No

Publications

  • Besse B, Planchard D, Veillard AS, Taillade L, Khayat D, Ducourtieux M, Pignon JP, Lumbroso J, Lafontaine C, Mathiot C, Soria JC. Phase 2 study of frontline bortezomib in patients with advanced non-small cell lung cancer. Lung Cancer. 2012 Apr;76(1):78-83. doi: 10.1016/j.lungcan.2011.09.006. Epub 2011 Dec 18.

    PubMed 22186627

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bortezomid (VELCADE®) in people with STAGE IIIB OR IV NON-SMALL CELL LUNG CANCER, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: stopped after planned interim analysis for lack of efficacy). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of VELCADE as determined by the rate of no progression at 6 weeks. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00346645, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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