Evaluating alectinib in patients with advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Alectinib with Radiation Therapy for Advanced Lung Cancer with ALK Mutation

  This study is testing if combining alectinib with targeted radiation therapy can help people with advanced lung cancer that has an ALK mutation feel better and live longer.

  Recruiting Karolinska University Hospital · Stockholm · NCT05724004

• Combining Pembrolizumab, Bevacizumab, and Chemotherapy for Advanced Lung Cancer with ALK Mutation

  This study is testing a new combination of two drugs and chemotherapy to see if it helps people with advanced lung cancer that has an ALK mutation and hasn't improved with another treatment.

  Recruiting Phase 2 Hunan Province Tumor Hospital · Changsha, Hunan · NCT05266846

• Alectinib plus duvelisib for ALK-positive anaplastic large cell lymphoma

  This trial tests whether combining alectinib with duvelisib is a safe, time-limited treatment for people with relapsed or refractory ALK-positive anaplastic large cell lymphoma.

  Recruiting at 7 sites Phase 1 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07001384

• Evaluating outcomes of ALK-positive lung cancer patients treated with Alectinib after surgery

  This study is testing if Alectinib can help adults with ALK-positive lung cancer feel better after their surgery.

  Recruiting at 43 sites Hoffmann-La Roche · Zhanjiang, Guangdong and 43 other locations · NCT06862869

• Treatment for advanced ALK-positive non-small cell lung cancer

  This study is testing whether a new drug called neladalkib can help people with advanced ALK-positive non-small cell lung cancer live longer without their disease getting worse compared to the standard treatment, alectinib.

  Recruiting at 158 sites Phase 3 Nuvalent Inc. · Glendale, Arizona and 158 other locations · NCT06765109

• Combining chemotherapy with Lorlatinib for ALK positive lung cancer

  This study is testing if combining chemotherapy with Lorlatinib can help people with ALK positive lung cancer who have seen their disease get worse while on Lorlatinib.

  Recruiting Phase 2 Centro di Riferimento Oncologico - Aviano · Aviano and 8 other locations · NCT06378892

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.