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:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT06139627
Eligibility Criteria:
Inclusion Criteria:
* ONCOLOGY PHYSICIANS INCLUSION:
* Oncology physicians must work at the participating site with no plans to leave that site or retire at the time of enrollment into the study
* PATIENTS INCLUSION:
* Any patient with unresectable non-small cell lung cancer diagnosis who is 60 years of age or older and must be treated at the participating site
* Clinical staging without pathological confirmation of nodal disease is allowed
* Plan to start a new cancer treatment regimen within 4-6 weeks from time of baseline study visit. The treatment regimen is up to the discretion of the treating oncology physician. The regimen must include a chemotherapy drug or other agents that have similar prevalence of toxicity. This can be either concurrent or sequential with radiation therapy
* Chemotherapy will be defined as cytotoxic drugs; in addition, agents (e.g., monoclonal antibodies and targeted agents) will be allowed. Given the rapidly changing landscape of new drugs for cancer, the study team led by the principal investigator (PI) will update the list accordingly after reviewing the toxicity profile of new therapies
* Patients who are receiving approved cancer treatment in combination or sequentially with radiation including hypo fractionated radiation (45-60Gy in 15-20 fractions) are eligible
* Those patients with oligometastatic disease having only one site and one lesion outside of the radiation field will be eligible. Examples include a solitary brain metastasis (met), contralateral lung nodule or an adrenal metastatic site
* A patient may also be enrolled on a treatment trial and participate in this study, if all other inclusion and exclusion criteria are met
* Able to provide informed consent, or if the oncology physician determines the patient to not have decision-making capacity, a patient-designated health care proxy (or authorized representative per institutional policies) must sign consent by the baseline visit
* Participant or healthcare proxy has adequate understanding of the English language (preferred) because not all GA measures have been validated in other languages. Study team should be contacted for any participants with other preferred languages including Spanish and Mandarin. Inclusion of these participants will depend upon the availability of the translators and their ability to accurately translate the measures as approved by the local Institutional Review Board (IRB)
Exclusion Criteria:
* PATIENTS EXCLUSION:
* Have surgery planned within 3 months of approach date. Patients who have previously received surgery are eligible
* Presence of symptomatic brain metastases (if more than one) at time of study consent process. Patients with history of treated brain metastases or small indeterminate lesions (\< 1cm) are eligible if they are not symptomatic at the time of study enrollment
* More than one metastatic site: Examples: brain and adrenal, adrenal and liver
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT06139627
Study Brief:
Protocol Section:
NCT06139627