Can a cancer drug stall advanced lung cancer?

NCT ID NCT00346645

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This phase II trial is testing whether bortezomib, a drug that interferes with cancer cell growth, can help people with advanced non-small cell lung cancer. Participants have stage IIIB or IV disease and have not received prior chemotherapy. The main goal is to see if the drug can prevent the cancer from progressing at six weeks, with additional measures of response and survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bortezomib (Velcade), a drug that blocks cancer cell growth
What this could lead to
If effective, bortezomib could offer a new treatment option for people with advanced non-small cell lung cancer who have not yet had chemotherapy.
What could go wrong
This is an early-phase study with a small number of patients, so results may not be conclusive. Bortezomib can cause side effects like fatigue, nausea, and nerve damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 46 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Jun 2006

Finished

Dec 2007

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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, Herceptin) * 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 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. 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 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institut Gustave Roussy

    Villejuif, 94800, France