Alectinib Pharmacokinetic in Patients With NSCLC

April 6, 2026 updated by: Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico

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 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?

In phase I (on days 0, 21, and 42), oral alectinib will be administered twice per day (BID) to patients with ALK-positive NSCLC; starting with 300 mg BID in 21-day cycles and dose escalation in 150 mg increments until 600 mg BID. Blood samples will be taken before and after administration of each dose (on days 1, 22, and 43). The primary endopoints in phase I will be dose-limiting toxicity (DLT) and PK parameters (Cmax. maximum plasma concentration; Tmax: time to reach maximum concentration: AUC 1-12: area under plasma ocncentrations-time curve steady-state concentration). At the end of the last blood collection (at day 43), the evaluation of each cycle will be at 600 mg, and the participant will be discharged to continue their treatment on an outpatient basis. Phase one will finish on day 63 of the study.

In phase II, the chosen BID dose based on the phase I portion will be administrated until disease progression, development of unacceptable side effects, or withdrawal of consent. The primary endpoint in phase 2 is the overall response rate (ORR) per RECIST V.1.1.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Alectinib will be administrated under fast conditions.

The primary endpoint of the phase II part was ORR. Other secondary endpoints in phase II are progression-free survival (PFS), overall survival (OS), intracranial response (ICR), and duration of response (DOR).

Exploratory endpoints in this follow-up analysis included the evaluation of the correlation between tumor shrinkage and PFS and chosen dose to relieve cancer symptoms.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Oscar G Arrieta Rodriguez, M.D., M.Sc.
  • Phone Number: 71101 5556280400
  • Email: ogar@unam.mx

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • Recruiting
        • Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología
        • Contact:
          • Oscar G Arrieta, M.D., M.Sc.
          • Phone Number: 71101 5556280400
          • Email: ogar@unam.mx

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alectinib escalation dose
Alecensa 150 mg Roche
Drug: Alectinib Oral Product
Alectinib is administered with a sequential dose escalation every 21 days from 300 to 600mg twice daily in the phase 1 portion. In phase 2, patients received an investigator-chosen dose based on the PK analysis.
Other Names:
  • Alecensa 150 mg Roche

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: Amount of drug concentration between 0 to 12 hours after first drug administration
The area under the curve (AUC). Pharmacokinetic behavior of the initial alectinib for each given dose (300, 450 and 600 mg).
Amount of drug concentration between 0 to 12 hours after first drug administration
Cmax
Time Frame: From baseline control pre-dose, 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00 and 11.90 hours
Highest concentration of drug in blood (Serum) for each given dose (300, 450 and 600 mg).
From baseline control pre-dose, 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00 and 11.90 hours
Cmin
Time Frame: From baseline control pre-dose, 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00 and 11.90 hours
Lowest concentration of drug in blood (Serum) for each given dose (300, 450 and 600 mg).
From baseline control pre-dose, 0.50, 1.00, 2.00, 3.00, 4.00, 5.00, 6.00, 8.00, 10.00 and 11.90 hours
Tmax
Time Frame: From first dose administration through the following 12 hours (day 1)
Time in witch Cmax is reached in each dose of the drug (300,450 and 600 mg)
From first dose administration through the following 12 hours (day 1)
ORR
Time Frame: From first dose administration up to disease progression by CT scan every 6 weeks, through study completion.
overall response rate is measured in phase two
From first dose administration up to disease progression by CT scan every 6 weeks, through study completion.
Steady state
Time Frame: For phase two: between 2 and 4 months of treatment with investigators chosen dose.
The amount of drug in the plasma has built up to a therapeutically effective concentration level, and as long as regular doses are administered to balance the amount of drug being cleared, the drug will continue to be active.
For phase two: between 2 and 4 months of treatment with investigators chosen dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: From date of first dose administration through 9 weeks.
Tolerance during drug escalation doses (300, 450, and 600 mg) in the phase one portion based on the PK analysis.
From date of first dose administration through 9 weeks.
Drug toxicity
Time Frame: From date of starting phase 2 portion until the date of first documented progression date or death from any cause, whichever comes first, assessed up to 60 months.
Adverse events under alectinib Administration a the chosen dose are measured in the phase two portion.
From date of starting phase 2 portion until the date of first documented progression date or death from any cause, whichever comes first, assessed up to 60 months.
PFS
Time Frame: From date of first dose administration until the date of first documented progression date or death from any cause, whichever comes first, assessed up to 100 months.
Progression-free survival
From date of first dose administration until the date of first documented progression date or death from any cause, whichever comes first, assessed up to 100 months.
OS
Time Frame: From date of first dose administration until the date of documented death from any cause or last follow-up, whichever comes first, assessed up to 120 months.
overall survival
From date of first dose administration until the date of documented death from any cause or last follow-up, whichever comes first, assessed up to 120 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Cancerologia de Mexico

Investigators

  • Principal Investigator: Oscar G Arrieta Rodriguez, M.D., M.Sc., Instituto Nacional De Cancerologia de Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 022/023/ICI_CEI/1583/21_V.2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ALK Gene Mutation

Clinical Trials on Alectinib Oral Product

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe