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New treatment option for Non-small Cell Lung Cancer Stage IIIB
Official title Alectinib Pharmacokinetic in Patients With NSCLC
ClinicalTrials.gov ID: NCT05713006
What this study is testing
What is Alectinib Oral Product?
Alectinib Oral Product is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for non-small cell lung cancer stage iiib.
Also referred to as Alecensa 150 mg Roche.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This interventional study aims to determine the pharmacokinetics of orally administered alectinib with dose escalation from 300 mg to 600 mg twice daily in Mexican patients with advanced ALK-positive NSCLC. The main question it aims to answer is: what will be the peak plasma concentrations of alectinib following sequential dose escalation (300, 450, and 600 mg BID) over nine weeks of pharmacokinetic evaluation (phase I) in Mexican patients with advanced ALK-rearranged NSCLC?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.
See the full eligibility 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
- 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...
- Active hepatitis virus infection (any serotype) or chronic infection with a potential risk of reactivation evaluated through a serological panel.
- Active HIV infection.
- Breastfeeding.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.