ALK-positive Non-small Cell Lung CancerNCT06361589
Real World Study of Lolatinib for Advanced ALK+ NSCLC Patients
An observational study of ALK-positive Non-small Cell Lung Cancer and Real World Study, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
Trial summary
This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK-positive Non-small Cell Lung Cancer, Real World Study
- What is being tested?
- Lorlatinib
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 1 Nov 2028
- Phase
- Observational
- 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
Study population: All eligible patients with ALK-mutated non-small cell lung cancer were included.
Who may be able to join
- Voluntary participation in this clinical study, understanding of study procedures, and ability to sign written informed consent.
- Age ≥18 years.
- Locally advanced or metastatic (inoperable stage IIIa or IIIb-IV) NSCLC with disease staging according to the American Joint Committee on Cancer (AJCC)/UICC 8th edition lung cancer staging criteria.ALK fusion mutations confirmed by tumor histology or hematology.
- Expected survival greater than 12 weeks.
- Adequate bone marrow reserve, organ function, and coagulation as assessed by the investigator as evidenced by complete blood count, biochemical parameters in blood and urine, coagulation, and electrocardiogram or cardiac ultrasound at baseline.
- Can take the medicine orally and swallow it.
- Female patients of childbearing potential are willing to use appropriate contraception and should not breastfeed within 6 months from signing the main informed consent to efficacy evaluation/end of medication (whichever is later); Male patients were willing to use barrier contraception (i.e., condom) for 6 months from signing the main informed consent until the efficacy assessment/end of medication, whichever occurred later.
- Female patients have a negative blood pregnancy test within 3 days before enrollment or meet one of the following criteria to demonstrate no risk of pregnancy: a. Postmenopausal is defined as age 50 years or older and amenorrhea for at least 12 months after cessation of all exogenous hormone replacement therapy; b. Females less than 50 years of age may also be considered postmenopausal if they have been amenorrhoeic for 12 months or more after cessation of all exogenous hormonal therapy and have luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels within the laboratory postmenopausal reference values; c. History of irreversible sterilization, including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, except for bilateral tubal ligation.
Who cannot join
- Use of strong CYP3A4 inhibitors, strong inducers, or drugs with a narrow therapeutic window that are sensitive substrates of CYP3A4 within 7 days and need to continue treatment with these drugs during the study.
- Patients with known active infectious diseases, such as active hepatitis B or C or HIV infection of human immunodeficiency virus, active hepatitis B and C including hepatitis B or C surface antigen (+) patients receiving intravenous treatment for infection - patients receiving oral antiviral suppression of hepatitis B or C will be allowed to participate in the study.
- Any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition that is not appropriate for the use of lorlatinib, or would affect the interpretation of the study results, or place the patient at high risk.
- Female patients who are pregnant, breastfeeding, or plan to become pregnant during the study.
- Patients with hypersensitivity to any active or inactive ingredient of lorlatinib.
- Any other patient who, in the judgment of the investigator, may have poor compliance with the study procedures and requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan cancer hospital
Chengdu, Sichuan, 610000
Juan Li, MD, 13880276636, dr.lijuan@hotmail.com
About this study
Official title: Real World Study of Lolatinib for Patients With Advanced/Metastatic Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC)
This study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain/meningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients.
- Being tested
- Lorlatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorlatinibDrug
lolatinib 100mg qd po
| Study group | Role | What they receive |
|---|---|---|
| Advanced ALK+ NSCLC Patients | Not described Receives: Drug: Lorlatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Intracranial and systemic PFS as assessed by the investigators using RECIST V1.1 or RANO-BM Separately.
Measured: From date of receiving therapy until date of disease progression or death.Approximately 5 years following the first dose of study drugs
Secondary outcomes (6)
OS
Overall survival for first-line and late-line of lorlatinib medication
Measured: From date of receiving therapy until date of death.Approximately 5 years following the first dose of study drugs
ORR
the Sum of percentage of participants with CR and PR as assessed by RECIST v1.1 or RANO-BM criteria every 8-12 weeks.
Measured: From date of receiving therapy until date of disease progression or the end of study, up to approximately 5 years.
AE
Number and percentage of participants with treatment-related AEs as assessed by CTCAE v5.0, and the duration of AEs on every grade.
Measured: Approximately 5 years following the first dose of study drugs.
PRO1
Change from baseline in quality of life of patients on EORTC QLQ-C30 at every 8-12 Weeks.
Measured: Approximately 5 years following the first dose of study drugs.
PRO2
Change from baseline in quality of life complemented by EORTC QLQ-LC29 at every 8-12 Weeks.
Measured: Approximately 5 years following the first dose of study drugs.
PRO3
Change from baseline in activities of daily living of patients with CNS metastases on EORTC QLQ-BM20 at every 8-12 Weeks.
Measured: Approximately 5 years following the first dose of study drugs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-positive Non-small Cell Lung CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Cancer Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan LI, MD, Sichuan Cancer Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06361589
- Sponsor's protocol ID
- EK2023003-1
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of Lolatinib for Patients With Advanced/Metastatic Anaplastic Lymphoma Kinase (ALK) - Positive Non-Small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT06361589
- Acronym / sponsor ID
- EK2023003-1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sichuan Cancer Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 12 Apr 2024 (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 study was a multicenter, prospective, non-interventional clinical study that included first-line and late-line patients with advanced non-small cell lung cancer with ALK fusions treated with the third generation ALK-TKI lorlatinib until disease progression, intolerable toxicity, investigator or subject decision to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death. Clinical pathology including sex, age, ALK mutation status at diagnosis, and clinical stage at diagnosis were collected from medical records. Physical condition as assessed by ECOG-PS before administration of lorlatinib was also recorded. Treatment information was obtained from the records, including dose and timing of ALK-TKI therapy and tumor response, number of prior systemic lines of therapy, and local treatment modalities such as radiotherapy and surgery. Quality of life based on the EORTC QLQ C30+LC29 scale (plus the EORTC QLQ BN20 scale in patients with brain/meningeal metastases) was performed at baseline and at each follow-up point. This study will use REDCap platform to collect and manage the study data information of multi-center patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced ALK+ NSCLC Patients | – | Drug: Lorlatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All eligible patients with ALK-mutated non-small cell lung cancer were included.
Key inclusion criteria (8 listed)
- Voluntary participation in this clinical study, understanding of study procedures, and ability to sign written informed consent.
- Age ≥18 years.
- Locally advanced or metastatic (inoperable stage IIIa or IIIb-IV) NSCLC with disease staging according to the American Joint Committee on Cancer (AJCC)/UICC 8th edition lung cancer staging criteria.ALK fusion mutations confirmed by tumor histology or hematology.
- Expected survival greater than 12 weeks.
- Adequate bone marrow reserve, organ function, and coagulation as assessed by the investigator as evidenced by complete blood count, biochemical parameters in blood and urine, coagulation, and electrocardiogram or cardiac ultrasound at baseline.
Key exclusion criteria (6 listed)
- Use of strong CYP3A4 inhibitors, strong inducers, or drugs with a narrow therapeutic window that are sensitive substrates of CYP3A4 within 7 days and need to continue treatment with these drugs during the study.
- Patients with known active infectious diseases, such as active hepatitis B or C or HIV infection of human immunodeficiency virus, active hepatitis B and C including hepatitis B or C surface antigen (+) patients receiving intravenous treatment for infection - patients receiving oral antiviral suppression of hepatitis B or C will be allowed to participate in the study.
- Any other disease, metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the judgment of the investigator, has reason to suspect that the patient has a disease or condition that is not appropriate for the use of lorlatinib, or would affect the interpretation of the study results, or place the patient at high risk.
- Female patients who are pregnant, breastfeeding, or plan to become pregnant during the study.
- Patients with hypersensitivity to any active or inactive ingredient of lorlatinib.
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 |
|---|---|---|
| Lorlatiniblolatinib 100mg qd po | Drug | Advanced ALK+ NSCLC Patients |
Primary outcome
PFS
Time frame: From date of receiving therapy until date of disease progression or death.Approximately 5 years following the first dose of study drugs
Intracranial and systemic PFS as assessed by the investigators using RECIST V1.1 or RANO-BM Separately.
6 secondary outcomes
OS
Time frame: From date of receiving therapy until date of death.Approximately 5 years following the first dose of study drugs
ORR
Time frame: From date of receiving therapy until date of disease progression or the end of study, up to approximately 5 years.
AE
Time frame: Approximately 5 years following the first dose of study drugs.
PRO1
Time frame: Approximately 5 years following the first dose of study drugs.
PRO2
Time frame: Approximately 5 years following the first dose of study drugs.
PRO3
Time frame: Approximately 5 years following the first dose of study drugs.
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 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALK-positive Non-small Cell Lung Cancer and Real World Study, run by Sichuan Cancer Hospital and Research Institute at 1 site in China.
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 8 inclusion and 6 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 12 Apr 2024. 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 China. 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of receiving therapy until date of disease progression or death.Approximately 5 years following the first dose of study drugs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2024.