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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
Renal: Creatinine less than 1.5 times ULN, Creatinine clearance greater than 60 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying giving chemotherapy with or without ZD 1839 to see if it is more effective in treating patients with stage IIIB or stage IV non-small cell lung cancer.
Who is the study for?
This trial is for adults with stage IIIB or IV non-small cell lung cancer who haven't had chemotherapy. They must be relatively healthy, with good blood counts and no severe heart, liver, or lung disease. People taking certain drugs that affect the body's enzyme systems or hormone therapies known to impact lung cancer can't join.Check my eligibility
What is being tested?
The study is testing whether adding ZD 1839 to standard combination chemotherapy improves outcomes in patients with advanced non-small cell lung cancer. Participants are randomly assigned to receive either just chemo or chemo plus ZD 1839.See study design
What are the potential side effects?
ZD 1839 may cause skin reactions, diarrhea, and abnormal liver function tests. Chemotherapy can lead to hair loss, nausea, fatigue, increased risk of infection due to low blood counts, and other organ-related side effects.
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 kidney function tests are within normal limits.
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My heart condition is stable and under control.
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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.
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My liver function tests are within the required range.
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My lung condition is stable and not severe.
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
4,267 Previous Clinical Trials
288,611,981 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 kidney function tests are within normal limits.My heart condition is stable and under control.I am not taking any medications known to strongly affect liver enzyme activities.I am 18 years old or older.I can take care of myself and perform daily activities.My liver function tests are within the required range.My lung condition is stable and not severe.
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 people still able to sign up for this research project?
"Although this trial is not seeking patients at the moment, that doesn't mean it won't in the future. This study was initially posted on 5/1/2000 and was last edited on 12/18/2013. Right now, there are 2098 other trials actively recruiting patients."
Answered by AI
What is the risk profile for patients who undergo this treatment?
"There is some efficacy data from Phase 3 trials as well as additional safety data, so the Power team rates this treatment a 3 on our scale."
Answered by AI
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