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:
2025-12-26 @ 5:20 PM
Ignite Modification Date:
2025-12-26 @ 5:20 PM
NCT ID:
NCT05713006
Eligibility Criteria:
Inclusion Criteria:
* Both sexes
* ≥ 18 years old
* Pathologically confirmed diagnosis of NSCLC
* Stage IIIB - IV by the American Joint Committee of Cancer Version 8.
* Recurrent disease (at least 180 days from curative intent treatment)
* ALK rearrangements tested by FDA-approved tests (IHQ or FISH)
* Karnofsky PS scale ≥ 70%
* Having received first-line treatment with anti-ALK inhibitors and one previous line of platinum-based chemotherapy.
* Measurable disease as referred by RECIST version 1.1
* Symptomatic brain metastases could receive prior treatment with radiotherapy or surgery for at least two weeks before treatment initiation.
* Asymptomatic brain metastases could not receive local therapy before study inclusion.
* Negative highly sensitive pregnancy test (serum or urine) within 72 days before first dose intervention.
* Sexually active patients should use a contraceptive method with a failure rate of less than 1% per year.
* Signed written informed consent
* Adequate organ function (hematological, liver, and renal function)
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Carcinomatous meningitis confirmed by a positive CRL cytology or highly suspicious brain MRI.
* Previous malignancies except for any carcinoma in-situ
* Treatment with other anti-cancer therapy
* Participating in other clinical trials in the former four weeks
* Any other serious condition or uncontrolled active infection, altered mental status, or psychiatric condition that, in the investigator´s opinion, would limit the ability of an individual to meet the requirements of the study or which affects the interpretability of the results.
* Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.
* Active HIV infection.
* Breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05713006
Study Brief:
Protocol Section:
NCT05713006