ALK-Positive NSCLCNCT06904547
Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC
An observational study of ALK-Positive NSCLC, run by Shanghai Chest Hospital.
Trial summary
This is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK-Positive NSCLC
- What is being tested?
- Non Interventional Study
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2025to 31 Dec 2030
- 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: adult patients with ALK-positive locally advanced or metastatic NSCLC
Who may be able to join
- Age: Patients aged 18 years or older;
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS).
- first-line loelaninab treatment fom Apr2023-Apr-2027.
- Evidenoe of popression to first-line lorlztinib within 2 weekes.
Who cannot join
- Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib;
- Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC: A Multi-center, Observational, Prospective Real-world Cohort Study (LORES)
This is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.
- Conditions
- ALK-Positive NSCLC
- Being tested
- No intervention administered, Non Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention administeredOther
No intervention administered
Non Interventional StudyOther
Non Interventional Study
What is being measured
The primary outcome is the main question the study is designed to answer.
mechanisms of resistance to first-line lorlatinib
Reslstance Assessment
- Liquld Blops-Blood eIDNA NGS
- Tissue Biopsy (If applicablo)-NGS mechanisms of resistance to first-line lorlatinib
- Propression pattern
- Priary ressstance
- Acquined resistance
- Moleculsr mechanisms of progression via ctDNA/organize NGS testing.
- Difference between the mnechsnisins of primary and acquired resistance
Measured: 24 months
Secondary outcomes (1)
Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib
- rwTTD1： discontinuation of lorlatinib for any reason (including disease progression, death, severe adverse events, or patient choice)
- rwTTD2： progression on first-line lorlatinib to discontinuation of the first sequential anti-tumor treatment for any reason (including disease progression, death, severe adverse events, or patient withdrawal from the study)
- rwORR2: the overall proportion of patients who achieve complete response (CR) and partial response (PR)
- rwDCR2: the overall proportion of patients who achieve complete response (CR), partial response (PR), and stable disease (SD)
- rwPFS2: progression on first-line lorlatinib to disease progression or death from any cause or last confirmed survival 6、1-year/2-year-rwPFS2 rate: he proportion of patients who remain progression-free within 1 year/2 years
7、the overall proportion of patients who survive within 1 year/2 years 8、Exploration of the proportion and related reasons for dose adjustment
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK-Positive NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ziming Li, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904547
- Sponsor's protocol ID
- IS25052
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Mechanisms and Sequential Treatment Strategies Following First-Line Lorlatinib in ALK-Positive NSCLC: A Multi-center, Observational, Prospective Real-world Cohort Study (LORES)
- ClinicalTrials.gov ID
- NCT06904547
- Acronym / sponsor ID
- IS25052
- Conditions
- ALK-Positive NSCLC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 1 Apr 2025 (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 is a prospective, multicenter, non-interventional, single-arm, real-world study planned to be conducted in China, aimed at exploring the resistance mechanisms of first-line lorlatinib treatment in patients with ALK-positive locally advanced or metastatic NSCLC, as well as the efficacy and safety of sequential treatments following lorlatinib resistance in the real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients with ALK-positive locally advanced or metastatic NSCLC
Key inclusion criteria (5 listed)
- Age: Patients aged 18 years or older;
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC
- Documened ALK resrrangemen by approved test (eg.. FisH,IHC. .r NGS).
- first-line loelaninab treatment fom Apr2023-Apr-2027.
- Evidenoe of popression to first-line lorlztinib within 2 weekes.
Key exclusion criteria (2 listed)
- Previous treatment with other ALK-TKIs: Patients who have previously received any ALK TKI other than lorlatinib;
- Concomitant medications: Patients who have received any systemic anti-tumor treatment other than lorlatinib before enrollment.
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 |
|---|---|---|
| No intervention administeredNo intervention administered | Other | – |
| Non Interventional StudyNon Interventional Study | Other | – |
Primary outcome
mechanisms of resistance to first-line lorlatinib
Time frame: 24 months
Reslstance Assessment 1. Liquld Blops-Blood eIDNA NGS 2. Tissue Biopsy (If applicablo)-NGS mechanisms of resistance to first-line lorlatinib 1. Propression pattern * Priary ressstance * Acquined resistance 2. Moleculsr mechanisms of progression via ctDNA/organize NGS testing. 3. Difference between the mnechsnisins of primary and acquired resistance
1 secondary outcome
Exploring the sequential treatment strategies and their efficacy and safety after first-line progression with lorlatinib
Time frame: 24 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 11 Apr 2025.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of ALK-Positive NSCLC, run by Shanghai Chest Hospital.
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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Li Zi ming (18017321562, liziming1980@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mechanisms of resistance to first-line lorlatinib (time frame: 24 months). 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 11 Apr 2025.