Recurrent Non-small Cell Lung CancerPhase 2NCT00004883
Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
A Phase 2 study testing trastuzumab and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- What is being tested?
- trastuzumab and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Aug 2005
- 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 confirmed stage IIIB or IV non-small cell lung cancer
- Supraclavicular node involvement allowed
- Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative)
- No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
- Recurrent disease allowed
- HER2 overexpression (2-3+)
Show all 38Show fewer
- At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques
- At least 10 mm by spiral CT scan
- The following are not considered measurable:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses not confirmed and followed by imaging
- Cystic lesions
- No CNS metastases
- Performance status - ECOG 0-2
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Creatinine no greater than 1.5 times ULN
- LVEF at least 45% (by echocardiogram or MUGA)
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No concurrent immunologic disease (e.g., autoimmune disease)
- No history of allergy to murine products
- No prior murine antibodies
- No prior anthracyclines
- No more than 1 prior chemotherapy regimen for lung cancer
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic
- No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
- At least 6 months since prior radiotherapy
- No concurrent palliative radiotherapy
- At least 4 weeks since prior major surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Read the detailed description
PRIMARY OBJECTIVES:
- Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer.
SECONDARY OBJECTIVES:
- Determine the duration of response in patients treated with this regimen. II. Determine the toxicity of this treatment regimen in this patient population.
III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population.
- Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression.
OUTLINE:
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression or death.
PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Being tested
- trastuzumab, laboratory biomarker analysis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trastuzumabBiological
Also called anti-c-erB-2, Herceptin, MOAB HER2
Given IV
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (trastuzumab) | Experimental | Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity. Receives: Biological: trastuzumab; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate (complete response [CR] and partial response [PR])
Measured: Up to 5 years
Secondary outcomes (5)
Overall survival (OS)
Kaplan-Meier curves will be used to describe OS.
Measured: From registration until death or last known follow-up, assessed up to 5 years
Failure-free survival (FFS)
Kaplan-Meier curves will be used to describe FFS.
Measured: Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years
Duration of response
Kaplan-Meier curves will be used to describe duration of response.
Measured: Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years
Toxicity as assessed by NCI's Common Toxicity Criteria
The frequency of occurrence of various toxicities will be tabulated by the most severe occurrence experienced by each individual patient.
Measured: Up to 5 years
Relationship between HER2 expression in tumor tissue and serum
A 95% confidence interval for this proportion will be estimated using the binomial distribution. The level of circulating HER2 receptor will be descriptively summarized with means, medians, quartiles, etc.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2003 (estimated)
- Study startFeb 2000
- Primary completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gerald Clamon, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004883
- Sponsor's protocol ID
- NCI-2012-02318
- Other IDs
- CLB-39810, U10CA031946, CDR0000067555
- Status last verified
- Jan 2013
- First submitted
- 7 Mar 2000
- Last updated
- 16 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00004883
- Acronym / sponsor ID
- NCI-2012-02318
- Conditions
- Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Feb 2000
- Primary completion
- Aug 2005 (actual)
- First posted
- 30 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed description
PRIMARY OBJECTIVES:
- Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer.
SECONDARY OBJECTIVES:
- Determine the duration of response in patients treated with this regimen. II. Determine the toxicity of this treatment regimen in this patient population.
III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population.
- Correlate circulating HER2 levels with non-small cell lung cancer tissue HER2 expression.
OUTLINE:
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression or death.
PROJECTED ACCRUAL: Approximately 84 patients (42 per stratum) will be accrued for this study within 17.5 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (trastuzumab) | Experimental | Biological: trastuzumab, Other: laboratory biomarker analysisPatients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1. Treatment continues once a week in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (38 listed)
- Histologically confirmed stage IIIB or IV non-small cell lung cancer
- No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
- Recurrent disease allowed
- HER2 overexpression (2-3+)
- At least 1 unidimensionally measurable lesion
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trastuzumabAlso: anti-c-erB-2, Herceptin, MOAB HER2Given IV | Biological | Treatment (trastuzumab) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (trastuzumab) |
Primary outcome
Response rate (complete response [CR] and partial response [PR])
Time frame: Up to 5 years
5 secondary outcomes
Overall survival (OS)
Time frame: From registration until death or last known follow-up, assessed up to 5 years
Failure-free survival (FFS)
Time frame: Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years
Duration of response
Time frame: Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years
Toxicity as assessed by NCI's Common Toxicity Criteria
Time frame: Up to 5 years
Relationship between HER2 expression in tumor tissue and serum
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Clamon principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing trastuzumab and laboratory biomarker analysis in people with Recurrent Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
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 38 inclusion and 0 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: finished, as of the sponsor's last update on 16 Jan 2013. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Response rate (complete response [CR] and partial response [PR]) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jan 2013.