Evaluating alectinib in patients with advanced lung cancer
A Phase I/II Open-label Clinical Trial to Evaluate the Pharmacokinetics of Alectinib With Sequential Dose Escalation in Patients Diagnosed With ALK-rearranged Advanced Non-small Cell Lung Cancer.
This study is testing how well alectinib works and how the body processes it in Mexican patients with advanced lung cancer that has a specific genetic change.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Instituto Nacional de Cancerologia de Mexico Academic / other |
| Drugs / interventions | chemotherapy, alectinib |
| Locations | 1 site (Mexico City, Mexico City) |
| Trial ID | NCT05713006 on ClinicalTrials.gov |
What this trial studies
This interventional study investigates the pharmacokinetics of alectinib, an oral medication, in Mexican patients diagnosed with advanced ALK-positive non-small cell lung cancer (NSCLC). The study consists of two phases: Phase I focuses on dose escalation from 300 mg to 600 mg taken twice daily, while monitoring peak plasma concentrations and dose-limiting toxicity. Blood samples will be collected at specified intervals to assess the drug's pharmacokinetic parameters. Phase II will evaluate the overall response rate and other secondary endpoints such as progression-free survival and overall survival.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with pathologically confirmed stage IIIB or IV NSCLC and documented ALK rearrangements.
Not a fit: Patients with asymptomatic brain metastases who have not received prior local therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal dosing of alectinib, potentially improving treatment outcomes for patients with advanced ALK-positive NSCLC.
How similar studies have performed: Other studies have shown promising results with alectinib in similar patient populations, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Mexico City, Mexico City
- Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología — Mexico City, Mexico City, Mexico (Recruiting)
Study contacts
- Principal investigator: Oscar G Arrieta Rodriguez, M.D., M.Sc. — Instituto Nacional de Cancerologia de Mexico
- Study coordinator: Oscar G Arrieta Rodriguez, M.D., M.Sc.
- Email: ogar@unam.mx
- Phone: 5556280400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.