Carcinoma, Non-Small-Cell LungPhase 2NCT00051571
Safety/Efficacy Study of Immunoconjugate With Docetaxel in Non-small Cell Lung Carcinoma
A Phase 2 study testing SGN-15 and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Seagen Inc. at 9 sites in United States.
Trial summary
This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- SGN-15 and Docetaxel
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- Start not givento Oct 2003
- 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
- Patients with pathologically confirmed NSCLC which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy.
- Lewis-y antigen expression documented by immunohistochemistry for all patients.
- Patients must have:
- Bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or
- Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion
- Performance status ≤ 2 (ECOG scale) with a life expectancy of at least 3 months
- Patients must be at least four weeks from prior treatment (chemotherapy, hormonal therapy, or definitive radiotherapy)
Who cannot join
- Prior therapy with TAXOTERE (docetaxel)
- Cumulative anthracycline exposure > 300 mg/m2.
- More than one primary malignancy with the exception of:
- Non-melanoma skin cancer
- In situ carcinoma of the cervix
- Localized prostate cancer
Show all 16Show fewer
- Completely resected stage I or II disease with no evidence of recurrent cancer from which the patient has remained disease free for more than 3 years.
- Uncontrolled significant non-malignant disease (e.g. congestive heart failure, bleeding, renal failure, hepatic failure).
- Uncontrolled, symptomatic brain metastasis.
- Peripheral neuropathy > grade 2.
- Concomitant therapy with other anti-neoplastic agents or experimental agents except for small volume radiation to a solitary bony metastasis.
- Active viral, bacterial or systemic fungal infections including known HIV or Hepatitis B or C.
- Women who are pregnant or breastfeeding
- Any serious underlying medical condition, which would impair the ability of the patient to receive the planned treatment including prior allergic reactions to recombinant human or murine proteins.
- Dementia or altered mental status that would prohibit the understanding and rendering of informed consent.
- Patients with uncontrolled peptic ulcer disease will be excluded.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Chicago
Chicago, Illinois, 60637
Florida Cancer Specialists
Fort Myers, Florida, 33901
Bendheim Cancer Center
Greenwich, Connecticut, 06830
UCLA Medical Center
Los Angeles, California, 90095
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952
Providence Health System
Portland, Oregon, 97213
Kaiser Permanente
Portland, Oregon, 97227
Virginia Mason Research Center
Seattle, Washington, 98101
Madigan Army Medical Center
Tacoma, Washington, 98431
About this study
Official title: A Phase II Study Using SGN-15 (cBR96-Doxorubicin Immunoconjugate) in Combination With Docetaxel for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma
This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. The objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen.
Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- SGN-15, Docetaxel
- Keywords
- Carcinoma, Non-Small-Cell Lung
- 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.
SGN-15Drug
DocetaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2003 (estimated)
- Study completionOct 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Sandler, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051571
- Sponsor's protocol ID
- SG0002-015
- Status last verified
- Oct 2011
- First submitted
- 13 Jan 2003
- Last updated
- 24 Oct 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Using SGN-15 (cBR96-Doxorubicin Immunoconjugate) in Combination With Docetaxel for the Treatment of Advanced Stage or Recurrent Non-Small Cell Lung Carcinoma
- ClinicalTrials.gov ID
- NCT00051571
- Acronym / sponsor ID
- SG0002-015
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Carcinoma, Non-Small-Cell Lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study completion
- Oct 2003 (actual)
- First posted
- 15 Jan 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.
This randomized phase II clinical trial evaluates the combination of a monoclonal antibody-based drug (SGN-15) with a chemotherapeutic agent compared to chemotherapy given alone in patients with non-small cell lung cancer that has failed at least one prior systemic therapy. The objective of the study is to determine the safety and clinical benefit, as measured by tumor response and quality of life, to the combination regimen.
Monoclonal antibody therapy has been used in other types of cancer to target therapy to the tumor, thereby allowing for the chemotherapeutic agent to have a lesser effect on normal, healthy tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with pathologically confirmed NSCLC which is metastatic or recurrent (non-resectable), who have failed at least one but no more than two prior therapies for advanced stage disease or have a recurrence within 6 months of completing adjuvant chemotherapy.
- Lewis-y antigen expression documented by immunohistochemistry for all patients.
- Bidimensionally or unidimensionally measurable disease on the basis of physical exam or imaging studies, or
- Evaluable disease: bone metastases defined on bone scan or malignant pleural effusion
- Performance status ≤ 2 (ECOG scale) with a life expectancy of at least 3 months
Key exclusion criteria (16 listed)
- Prior therapy with TAXOTERE (docetaxel)
- Cumulative anthracycline exposure > 300 mg/m2.
- Non-melanoma skin cancer
- In situ carcinoma of the cervix
- Localized prostate cancer
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 |
|---|---|---|
| SGN-15 | Drug | – |
| Docetaxel | Drug | – |
Primary outcome
Not reported in the source record.
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 24 Oct 2011.
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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.
Andrew Sandler, MD study director
Seagen Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGN-15 and Docetaxel in people with Carcinoma, Non-Small-Cell Lung, run by Seagen Inc. at 9 sites 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 7 inclusion and 16 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 24 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
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 24 Oct 2011; AzTrials last refreshed its copy on 7 Nov 2026.