Study on Erlotinib Hydrochloride for Patients with Stage IB-IIIA Non-small Cell Lung Cancer After Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02193282
This clinical trial is testing whether the drug erlotinib hydrochloride can help improve survival in patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. The study compares erlotinib to simply observing patients without additional treatment.
Patient Parameters
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Program Overview
The purpose of this study is to find out if taking erlotinib hydrochloride after surgery can help patients with stage IB-IIIA non-small cell lung cancer live longer. Erlotinib works by blocking certain enzymes that cancer cells need to grow. The study will compare the effects of erlotinib to just monitoring patients without giving them any additional treatment.
Description
The main goal of this study is to see if taking erlotinib hydrochloride after surgery can help patients with stage IB-IIIA non-small cell lung cancer live longer compared to just being observed. The study will also look at whether erlotinib can help patients stay cancer-free for longer periods and evaluate its safety when used after surgery.
Patients in the study are divided into different groups:
- One group takes erlotinib daily for up to two years, as long as the cancer does not return or side effects are manageable.
- Another group is observed without taking any additional treatment.
After finishing the study treatment, patients will have follow-up visits every six months for four years, and then once a year for six more years.
Eligibility Criteria
Inclusion Criteria
- Must have been previously registered in a related study and have lung cancer with specific EGFR mutations.
- Cancer must be completely removed by surgery and be stage IB (4 cm or larger), II, or IIIA non-squamous non-small cell lung cancer.
- Must have fully recovered from surgery and any required post-surgery treatments.
- Must be at least 18 years old.
- Must have a good performance status, meaning they are fully active or able to carry out light work.
- Must not have had any other advanced or metastatic cancer needing treatment in the past five years.
- Must not be pregnant or breastfeeding.
- Must have normal blood counts and organ function as shown by specific blood tests.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Southern Cancer Center PC-Daphne | 36526 | Daphne | Alabama |
| Southern Cancer Center PC-Mobile | 36607 | Mobile | Alabama |
| Southern Cancer Center PC-Providence | 36608 | Mobile | Alabama |
| Southern Cancer Center PC-Springhill | 36608 | Mobile | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Regional Hospital | 99508 | Anchorage | Alaska |
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