Non-small Cell Lung Cancer Stage IIIBPhase 1/2NCT05713006
Alectinib Pharmacokinetic in Patients With NSCLC
A Phase 1/2 study testing Alectinib Oral Product in people with Non-small Cell Lung Cancer Stage IIIB and ALK Gene Mutation, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer Stage IIIB, ALK Gene Mutation
- What is being tested?
- Alectinib Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteMexico
- Study dates
- 1 May 2022to 1 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 16Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Thoracic Oncology Unit and Personalized Medicine Laboratory, Instituto Nacional de Cancerología
Mexico City, Mexico City, 14080
Oscar G Arrieta, M.D., M.Sc., 5556280400 ext. 71101, ogar@unam.mx
About this study
Official title: 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?
Read more
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.
Read the 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.
- Being tested
- Alectinib Oral Product
- Keywords
- alectinib, positive-ALK, non small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alectinib Oral ProductDrug
Also called Alecensa 150 mg Roche
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.
| Study group | Role | What they receive |
|---|---|---|
| Alectinib escalation dose | Experimental | Alecensa 150 mg Roche Receives: Drug: Alectinib Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC
The area under the curve (AUC). Pharmacokinetic behavior of the initial alectinib for each given dose (300, 450 and 600 mg).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: From first dose administration through the following 12 hours (day 1)
ORR
overall response rate is measured in phase two
Measured: 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.
Measured: For phase two: between 2 and 4 months of treatment with investigators chosen dose.
Secondary outcomes (4)
Adverse events
Tolerance during drug escalation doses (300, 450, and 600 mg) in the phase one portion based on the PK analysis.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 May 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung Cancer Stage IIIBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients (≥18 years), both sex, clinical stage IIIB and IV, ALK-rearranged NSCLC treated by Thoracic Oncology Department at Instituto Nacional de Cancerología (INCan).
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cancerologia de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Gerardo Arrieta Rodríguez, Instituto Nacional de Cancerologia de Mexico
- Investigators
- Oscar G Arrieta Rodriguez, M.D., M.Sc., Principal investigator, Instituto Nacional de Cancerologia de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713006
- Sponsor's protocol ID
- 022/023/ICI_CEI/1583/21_V.2
- Status last verified
- Apr 2026
- First submitted
- 4 Jan 2023
- Last updated
- 8 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.
PubMed 29748847Sivignon M, Monnier R, Tehard B, Roze S. Cost-effectiveness of alectinib compared to crizotinib for the treatment of first-line ALK+ advanced non-small-cell lung cancer in France. PLoS One. 2020 Jan 16;15(1):e0226196. doi: 10.1371/journal.pone.0226196. eCollection 2020.
PubMed 31945065Carlson JJ, Suh K, Orfanos P, Wong W. Cost Effectiveness of Alectinib vs. Crizotinib in First-Line Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer. Pharmacoeconomics. 2018 Apr;36(4):495-504. doi: 10.1007/s40273-018-0625-6.
PubMed 29488070Hida T, Nokihara H, Kondo M, Kim YH, Azuma K, Seto T, Takiguchi Y, Nishio M, Yoshioka H, Imamura F, Hotta K, Watanabe S, Goto K, Satouchi M, Kozuki T, Shukuya T, Nakagawa K, Mitsudomi T, Yamamoto N, Asakawa T, Asabe R, Tanaka T, Tamura T. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial. Lancet. 2017 Jul 1;390(10089):29-39. doi: 10.1016/S0140-6736(17)30565-2. Epub 2017 May 10.
PubMed 28501140Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.
PubMed 28586279
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05713006
- Acronym / sponsor ID
- 022/023/ICI_CEI/1583/21_V.2
- Keywords
- alectinib, positive-ALK, non small cell lung cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cancerologia de MexicoUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients (≥18 years), both sex, clinical stage IIIB and IV, ALK-rearranged NSCLC treated by Thoracic Oncology Department at Instituto Nacional de Cancerología (INCan).
| Arm | Type | Receives |
|---|---|---|
| Alectinib escalation dose | Experimental | Drug: Alectinib Oral ProductAlecensa 150 mg Roche |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alectinib Oral ProductAlso: Alecensa 150 mg RocheAlectinib 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. | Drug | Alectinib escalation dose |
Primary outcome
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).
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).
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).
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)
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
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.
4 secondary outcomes
Adverse events
Time frame: 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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Background: PubMed 29748847Morcos PN, Nueesch E, Jaminion F, Guerini E, Hsu JC, Bordogna W, Balas B, Mercier F. Exposure-response analysis of alectinib in crizotinib-resistant ALK-positive non-small cell lung cancer. Cancer Chemother Pharmacol. 2018 Jul;82(1):129-138. doi: 10.1007/s00280-018-3597-5. Epub 2018 May 10.
- Background: PubMed 31945065Sivignon M, Monnier R, Tehard B, Roze S. Cost-effectiveness of alectinib compared to crizotinib for the treatment of first-line ALK+ advanced non-small-cell lung cancer in France. PLoS One. 2020 Jan 16;15(1):e0226196. doi: 10.1371/journal.pone.0226196. eCollection 2020.
- Background: PubMed 29488070Carlson JJ, Suh K, Orfanos P, Wong W. Cost Effectiveness of Alectinib vs. Crizotinib in First-Line Anaplastic Lymphoma Kinase-Positive Advanced Non-Small-Cell Lung Cancer. Pharmacoeconomics. 2018 Apr;36(4):495-504. doi: 10.1007/s40273-018-0625-6.
- Background: PubMed 28501140Hida T, Nokihara H, Kondo M, Kim YH, Azuma K, Seto T, Takiguchi Y, Nishio M, Yoshioka H, Imamura F, Hotta K, Watanabe S, Goto K, Satouchi M, Kozuki T, Shukuya T, Nakagawa K, Mitsudomi T, Yamamoto N, Asakawa T, Asabe R, Tanaka T, Tamura T. Alectinib versus crizotinib in patients with ALK-positive non-small-cell lung cancer (J-ALEX): an open-label, randomised phase 3 trial. Lancet. 2017 Jul 1;390(10089):29-39. doi: 10.1016/S0140-6736(17)30565-2. Epub 2017 May 10.
- Background: PubMed 28586279Peters S, Camidge DR, Shaw AT, Gadgeel S, Ahn JS, Kim DW, Ou SI, Perol M, Dziadziuszko R, Rosell R, Zeaiter A, Mitry E, Golding S, Balas B, Noe J, Morcos PN, Mok T; ALEX Trial Investigators. Alectinib versus Crizotinib in Untreated ALK-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2017 Aug 31;377(9):829-838. doi: 10.1056/NEJMoa1704795. Epub 2017 Jun 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oscar G Arrieta Rodriguez, M.D., M.Sc. principal investigator
Instituto Nacional de Cancerologia de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Alectinib Oral Product in people with Non-small Cell Lung Cancer Stage IIIB and ALK Gene Mutation, run by Instituto Nacional de Cancerologia de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oscar G Arrieta Rodriguez, M.D., M.Sc. (5556280400 ext. 71101, ogar@unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC (time frame: Amount of drug concentration between 0 to 12 hours after first drug administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05713006, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.