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 @ 9:30 PM
Ignite Modification Date:
2025-12-24 @ 9:30 PM
NCT ID:
NCT03132532
Eligibility Criteria:
Inclusion Criteria:
* Age \>= 18 years
* Histological confirmation of non-small cell lung cancer
* Forced expiratory volume in 1 second (FEV1) \> 1.0 L
* Unresectable or medically inoperable stage 2-3 non-small cell lung cancer (based on computed tomography/positron emission tomography \[CT/PET\], magnetic resonance imaging \[MRI\] or CT of brain, and physical exam);
* Eligible if recurrence after surgery and now has the equivalent stage 2-3 non-small cell lung cancer (NSCLC) OR had sub totally resected stage 2-3 NSCLC
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* White blood cell (WBC) \>= 3.0 x 10\^9/L
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Hemoglobin (Hgb) \>= 9 g/dl
* Platelets (plts) \> 100 x 10\^9/L
* Serum creatinine \< 1.5 x upper limits of normal (ULN)
* Serum bilirubin \< 1.5 x ULN
* Provide informed written consent
* Willing to return to enrolling institution for follow-up for a minimum of 1 year
* Ability to undergo potentially curative chemotherapy plus radiotherapy
Exclusion Criteria:
* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Weight loss of \> 10% in the past 3 months
* Distant metastases (M1 disease)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, lupus, usual interstitial pneumonitis (UIP), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Receiving any investigational agent, that would be considered as a treatment for the primary neoplasm
* Active second malignancy
* History of myocardial infarction =\< 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
* Received chemotherapy for lung cancer within 6 months of registration
* Previous chest radiotherapy that would overlap with the proton field
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03132532
Study Brief:
Protocol Section:
NCT03132532