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Erlotinib for Non-Small Cell Lung Cancer
Study Summary
This trial compares erlotinib hydrochloride to observation in treating patients with resected stage IB-IIIA non-small cell lung cancer. Erlotinib hydrochloride may stop tumor cell growth by blocking enzymes needed for cell growth.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 29 Patients • NCT01664897Trial Design
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- I am fully active or can carry out light work.My cancer does not have the T790M mutation in the EGFR gene.My lung cancer was surgically removed, it was stage IB (>= 4 cm), II or IIIA, and I didn't receive chemo or radiotherapy before surgery.I have fully recovered from my surgery and it's been the right amount of time since then.I have no history of cornea abnormalities.I haven't had any cancer that spread or needed whole-body treatment in the last 5 years, nor have I been diagnosed with a new lung cancer in the last 2 years.Your total bilirubin level is not higher than 1.5 times the upper limit of normal.Your SGOT blood test result is not more than 1.5 times the normal level.My lung cancer has a specific EGFR mutation, confirmed by a central lab.Your serum creatinine level is not more than 1.5 times the upper limit of normal.You have a healthy level of a type of white blood cell called granulocytes.You must have at least 100,000 platelets per microliter of blood.My cancer has both EGFR mutation and ALK rearrangement.
- Group 1: Arm A (blinded erlotinib hydrochloride)
- Group 2: Arm B (placebo)
- Group 3: Arm C (unblinded erlotinib hydrochloride)
- Group 4: Arm D (observation)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Has the FDA greenlit Erlotinib Hydrochloride?
"Erlotinib Hydrochloride has received a Phase 3 safety score of 3."
Is Erlotinib Hydrochloride a new medication?
"Initially, Erlotinib Hydrochloride was investigated in 2002 by Mayo Clinic's Rochester branch. Since then, a total of 997 clinical trials have concluded, with 52 more active trials taking place across the globe. A considerable amount of these active trials are based in Manitowoc, Wisconsin."
Are there any available slots in this experiment for new participants?
"Unfortunately, this trial is not currently recruiting patients. Although, it is worth noting that the study was first posted on 8/18/2014 and was most recently edited on 10/18/2022. If the patient is willing to look at other options, there are 3761 trials actively enrolling patients with non-small cell lung carcinoma and 52 trials for Erlotinib Hydrochloride that are looking for patients."
Is this Canadian clinical trial only being run in a few hospitals?
"Presently, this clinical trial is enrolling patients at multiple locations including Holy Family Memorial Hospital in Manitowoc, Wisconsin, MedStar Washington Hospital Center in Washington, District of Columbia, and Saint Francis Hospital in Federal Way, Washington. In total, there are 100 active recruitment sites."
For what purpose is Erlotinib Hydrochloride most often prescribed?
"Erlotinib Hydrochloride is a medication used to manage metastatic pancreatic cancer. Additionally, it has shown efficacy in the treatment of pancreatic carcinoma, malignant neoplasms, and in patients that have not yet undergone treatment."
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