Non-Small-Cell Lung CarcinomaPhase 3IMAC/HerbstNCT00090675
Maintenance ZD1839 (IRESSA®) Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
A Phase 3 study testing ZD1839 in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca.
Trial summary
In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small-Cell Lung Carcinoma
- What is being tested?
- ZD1839
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Nov 2007
- Phase
- Phase 3
- 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
- Must sign Informed Consent
- Females and males aged 18 years and over.
- Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.
- Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy.
- No prior EGFR therapy
- No newly diagnosed intracerebral metastases while receiving or after completing chemotherapy
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- At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy
- Must be completely healed from previous major oncologic surgery
- Life expectancy of ≥ 8 weeks.
Who cannot join
- Known severe hypersensitivity to ZD1839 or any of the excipients of these products.
- Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.
- Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
- Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy.
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- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
- Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases.
- Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy.
- Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.
About this study
Official title: A Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA®) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.
- Conditions
- Non-Small-Cell Lung Carcinoma
- Being tested
- ZD1839
- 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.
ZD1839Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2004 (estimated)
- Study startJan 2006
- Primary completionNov 2007 (estimated)
- Study completionNov 2007 (estimated)
Why it stopped: No patients randomised
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small-Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Iressa Medical Science Director, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090675
- Sponsor's protocol ID
- D7913L00019
- Other IDs
- Herbst trial
- Acronym
- IMAC/Herbst
- Status last verified
- Jan 2013
- First submitted
- 2 Sep 2004
- Last updated
- 29 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA®) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00090675
- Acronym / sponsor ID
- IMAC/Herbst / D7913L00019
- Conditions
- Non-Small-Cell Lung Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients randomised
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Nov 2007 (estimated)
- Study completion
- Nov 2007 (estimated)
- First posted
- 3 Sep 2004 (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.
In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must sign Informed Consent
- Females and males aged 18 years and over.
- Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC.
- Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy.
- No prior EGFR therapy
Key exclusion criteria (10 listed)
- Known severe hypersensitivity to ZD1839 or any of the excipients of these products.
- Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded).
- Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.
- Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia.
- Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
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 |
|---|---|---|
| ZD1839 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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.
Iressa Medical Science Director study director
AstraZeneca
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZD1839 in people with Non-Small-Cell Lung Carcinoma, run by AstraZeneca.
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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 29 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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 29 Jan 2013.