Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT02277457
Eligibility Criteria:
Inclusion Criteria:
* Patients with FDG-avid (radioactive glucose) and pathologically proven stage IIA-IIB or IIIA-IIIB non-small cell lung cancer (according to AJCC \[American Joint Committee on Cancer\] staging, 7th edition).
* Patients with tumors that harbor either EGFR sensitizing mutations or ALK rearrangement.
* Patients must be considered unresectable or medically inoperable; patients who decline surgery are also eligible.
* Patients must be 18 years of age or older.
* Patients with ECOG (Eastern Cooperative Oncology Group) performance status of 0-2.
* Patients must have adequate organ function.
* Patients must be able to take oral medications.
* Women with reproductive capability must be willing to use effective contraception.
* Patients must be informed of the investigational nature of this study and sign written informed consent in accordance with institutional and federal guidelines.
* Patients must be willing to comply with study procedures.
Exclusion Criteria:
* Patients with tumors that have a component of small cell carcinoma.
* Patients wtih stage I, II, or IV disease, including malignant pleural or pericardial effusion.
* Prior radiotherapy to the thorax such that composite radiation would significantly over-dose critical structures, either per estimation of the treating radiation oncologist or defined by failure to meet normal tissue tolerance constraints.
* Patients who cannot tolerate thoracic radiotherapy or targeted therapy.
* Patients wtih a prior diagnosis of interstitial lung disease or pulmonary fibrosis.
* Patients who cannot take oral medication, require intravenous alimentation, had prior surgical procedures affecting gastrointestinal absorption, or have active peptic ulcer disease.
* Hypersensitivity to erlotinib, crizotinib, or to any of the excipients.
* Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects.
* Prisoners are excluded from this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02277457
Study Brief:
Protocol Section:
NCT02277457