A Phase 1/2 interventional study of Alectinib Oral Product in Non-small Cell Lung Cancer Stage IIIB and ALK Gene Mutation, sponsored by Instituto Nacional de Cancerologia de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Instituto Nacional de Cancerologia de Mexico · Phase 1/2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Also known as: Alecensa 150 mg Roche
AUC
The area under the curve (AUC). Pharmacokinetic behavior of the initial alectinib for each given dose (300, 450 and 600 mg).
Time frame: Amount of drug concentration between 0 to 12 hours after first drug administration
Cmax
Highest concentration of drug in blood (Serum) for each given dose (300, 450 and 600 mg).
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
Cmin
Lowest concentration of drug in blood (Serum) for each given dose (300, 450 and 600 mg).
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
Tmax
Time in witch Cmax is reached in each dose of the drug (300,450 and 600 mg)
Time frame: From first dose administration through the following 12 hours (day 1)
ORR
overall response rate is measured in phase two
Time frame: From first dose administration up to disease progression by CT scan every 6 weeks, through study completion.
Steady state
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.
Time frame: For phase two: between 2 and 4 months of treatment with investigators chosen dose.
Adverse events
Tolerance during drug escalation doses (300, 450, and 600 mg) in the phase one portion based on the PK analysis.
Time frame: From date of first dose administration through 9 weeks.
Drug toxicity
Adverse events under alectinib Administration a the chosen dose are measured in the phase two portion.
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.
PFS
Progression-free survival
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.
OS
overall survival
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.
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Carcinoma, Non-Small-Cell Lung→
Instituto Nacional de Cancerologia de Mexico