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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically proven non-small cell lung cancer Stage III disease that is not curable with surgery or radiotherapy OR Stage IV disease chemotherapy naive
Hepatic: ALT or AST no greater than 2.5 times upper limit of normal (ULN) (no greater than 5 times ULN if liver metastasis present)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will compare the effectiveness of combination chemotherapy with or without ZD 1839 in treating patients who have stage III or stage IV non-small cell lung cancer.
Who is the study for?
This trial is for adults over 18 with non-small cell lung cancer that hasn't been treated with chemo yet. They should have a certain level of kidney, liver, and blood health, no severe heart or lung conditions, and not be pregnant or nursing. Participants must use contraception if they can have children.Check my eligibility
What is being tested?
The study is testing the effectiveness of ZD 1839 (a drug that may block tumor growth) combined with chemotherapy versus chemotherapy alone in patients with advanced stage III (not curable by surgery/radiotherapy) or stage IV non-small cell lung cancer.See study design
What are the potential side effects?
ZD 1839 might cause side effects like diarrhea and skin reactions. Chemotherapy can lead to hair loss, nausea, fatigue, increased risk of infection due to low blood counts, and other organ-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is at an advanced stage and hasn't been treated with chemotherapy.
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My liver tests are within the required range, even with liver metastasis.
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My kidney function, measured by creatinine, is within normal limits.
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My heart condition is stable and under control.
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My lung condition is stable and not severe.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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Who is running the clinical trial?
AstraZenecaLead Sponsor
4,259 Previous Clinical Trials
288,593,902 Total Patients Enrolled
Ron StaugarrdStudy ChairAstraZeneca
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer is at an advanced stage and hasn't been treated with chemotherapy.My liver tests are within the required range, even with liver metastasis.I am not taking any medications that strongly affect liver enzyme activity.My kidney function, measured by creatinine, is within normal limits.My heart condition is stable and under control.My lung condition is stable and not severe.I am not on any treatments that could affect the study's results.I am 18 years old or older.I can take care of myself and perform daily activities.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients being accepted into this research project at this time?
"This information is available on clinicaltrials.gov. The trial in question was last active 5/1/2000- 12/18/2013, and is not currently looking for participants. There are 2098 other trials that patients can sign up for."
Answered by AI
Does this medication have the FDA's OK?
"The safety of this intervention falls on the higher end of the spectrum because it is a Phase 3 trial. This indicates that while there may be some data supporting efficacy, there is multiple rounds of data affirming its safety."
Answered by AI
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