ALK Fusion-positive Non-small Cell Lung CancerPhase 4NCT07674368
Rucaparib Monoclonal Antibody for Lorlatinib-Induced Hypercholesterolemia / Mixed
A Phase 4 study testing Recaticimab in people with ALK Fusion-positive Non-small Cell Lung Cancer, run by Hunan Cancer Hospital at 1 site in China.
Trial summary
This prospective single-arm clinical study plans to enroll 29 participants with unresectable stage IIIB-IV ALK fusion-positive non-small cell lung cancer (NSCLC). Eligible patients must be aged ≥18 years with an ECOG performance status of 0-2 and have developed grade 1-3 hypercholesterolemia adverse events (AEs, per… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALK Fusion-positive Non-small Cell Lung Cancer
- What is being tested?
- Recaticimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2026to 1 Aug 2028
- Phase
- Phase 4
- 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
- Aged ≥ 18 years on the day of signing the informed consent form, with no gender restriction;
- Patients with unresectable stage IIIB/IIIC/IV non-small cell lung cancer (NSCLC) confirmed by cytology or histology (staging defined per the 9th edition of the International Association for the Study of Lung Cancer (IASLC) Staging Manual in Thoracic Oncology);
- Positive ALK fusion confirmed by genetic testing;
- Developed Grade 1-3 hypercholesterolemia adverse events after lorlatinib treatment (per CTCAE Version 5.0);
- Fasting triglyceride level ≤ 5.6 mmol/L at screening;
- Willing and able to comply with scheduled study visits, treatment regimens, laboratory tests and all other study procedures.
Who cannot join
- Subjects with known hypersensitivity to the investigational product, or a history of severe hypersensitivity reactions to other antibody-based drugs;
- Diagnosed with familial hypercholesterolemia per the Simon Broome Criteria;
- Received other PCSK9 inhibitors within 6 months prior to screening;
- Uncontrolled hypercholesterolemia (total cholesterol above the upper limit of normal) existed before lorlatinib initiation;
- Prior diagnosis of New York Heart Association (NYHA) Class III-IV cardiac dysfunction;
- Prior diagnosis of atherosclerotic cardiovascular disease (ASCVD), including acute coronary syndrome, stable coronary artery disease, post-revascularization status, ischemic cardiomyopathy, ischemic stroke, transient ischemic attack, peripheral atherosclerotic artery disease, etc.;
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- Prior diagnosis of severe arrhythmia, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response;
- Uncontrolled hypertension at screening or randomization (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);
- Prior diagnosis of diseases that significantly affect lipid levels, including nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;
- Prior diagnosis of Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus at screening (HbA1c >8.5%);
- Active infectious disease at screening judged by the investigator to render the subject ineligible for trial participation;
- Participation in another interventional clinical trial within 1 month before screening (excluding screen failures), or within 5 half-lives of the investigational product at screening (whichever duration is longer);
- History of drug abuse, illicit substance use, or chronic alcohol abuse prior to screening;
- Major surgery within 3 months before screening, or planned major surgery during the study period;
- Chronic continuous or repeated systemic glucocorticoid use within 3 months prior to screening (topical administration excluded, e.g., intra-articular, intranasal, inhaled, cutaneous external use; chronic continuous use defined as ≥7 consecutive days; repeated use defined as cumulative administration ≥3 courses);
- Weight-loss medication use or weight-altering bariatric surgery within 2 months prior to screening;
- Any laboratory test value meeting the following criteria at screening or randomization:
- Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² (calculated via the MDRD formula);
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN); for patients with liver metastases, ALT/AST >5×ULN; or total bilirubin >1.5×ULN;
- Creatine kinase (CK) >3×ULN;
- Thyroid-stimulating hormone (TSH) below the lower limit of normal (LLN) or >1.5×ULN;
- Positive human immunodeficiency virus antibody (HIV-Ab) or hepatitis C virus antibody (HCV-Ab); positive hepatitis B surface antigen (HBsAg) with HBV-DNA ≥1000 copies/mL (or ≥200 IU/mL; if the assay lower limit exceeds 1000 copies/mL or 200 IU/mL, HBV-DNA ≥ assay lower limit);
- Positive pregnancy test;
- Planned implantation of cardiac pacemaker, cardiac resynchronization therapy (CRT), implantable cardioverter-defibrillator (ICD), or equivalent device during the study period;
- Positive human immunodeficiency virus antibody (HIV-Ab) or hepatitis C virus antibody (HCV-Ab); positive hepatitis B surface antigen (HBsAg) with HBV-DNA ≥1000 copies/mL (or ≥200 IU/mL; if the assay lower limit exceeds 1000 copies/mL or 200 IU/mL, HBV-DNA ≥ assay lower limit);
- Judged by the investigator to be unsuitable for subcutaneous injection;
- The investigator determines the subject has poor compliance or any other factor precluding trial participation, including but not limited to conditions placing the subject at unacceptable risk or likely confounding study results.
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
Hunan Cancer Hospital
Changsha, Hunan, 410013
Xingxiang Pu, 86731-88651900, pxx_1354@163.com
About this study
Official title: A Prospective Single-Arm Clinical Study of Recakimab for Lorlatinib-Induced Hypercholesterolemia / Mixed Hyperlipidemia
This prospective single-arm clinical study plans to enroll 29 participants with unresectable stage IIIB-IV ALK fusion-positive non-small cell lung cancer (NSCLC). Eligible patients must be aged ≥18 years with an ECOG performance status of 0-2 and have developed grade 1-3 hypercholesterolemia adverse events (AEs, per CTCAE 5.0) after lorlatinib treatment. All subjects will receive recakimab 300 mg administered once every 8 weeks.
The primary endpoint is the percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 16. Secondary endpoints include absolute change in LDL-C at week 16; percentage and absolute change in LDL-C at week 32; percentage and absolute changes from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a) [Lp(a)] and triglycerides (TG) at weeks 16 and 32; proportion of patients whose hypercholesterolemia AEs return to normal at weeks 16 and 32; LDL-C target achievement rate at weeks 16 and 32; and safety profile related to recakimab.
- Being tested
- Recaticimab
- Keywords
- lunng cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecaticimabDrug
Recaticimab (SHR-1209) injection, a fully human monoclonal antibody targeting PCSK9. All eligible subjects will receive subcutaneous injection of recaticimab 300 mg once every 8 weeks during the treatment period. The administration cycle will be maintained up to 32 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Recakimab Treatment Arm | Experimental | Not described Receives: Drug: Recaticimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 16
Measured: 16 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start10 Jul 2026 (estimated)
- Primary completion10 Jul 2028 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALK Fusion-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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-group (Single-arm) interventional study: All enrolled subjects will receive recakimab 300 mg subcutaneous injection every 8 weeks.
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunan Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674368
- Sponsor's protocol ID
- MA-NSCLC-Ⅱ-059
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Arm Clinical Study of Recakimab for Lorlatinib-Induced Hypercholesterolemia / Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT07674368
- Acronym / sponsor ID
- MA-NSCLC-Ⅱ-059
- Keywords
- lunng cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Hunan Cancer HospitalUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 29 Jun 2026 (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 prospective single-arm clinical study plans to enroll 29 participants with unresectable stage IIIB-IV ALK fusion-positive non-small cell lung cancer (NSCLC). Eligible patients must be aged ≥18 years with an ECOG performance status of 0-2 and have developed grade 1-3 hypercholesterolemia adverse events (AEs, per CTCAE 5.0) after lorlatinib treatment. All subjects will receive recakimab 300 mg administered once every 8 weeks.
The primary endpoint is the percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at week 16. Secondary endpoints include absolute change in LDL-C at week 16; percentage and absolute change in LDL-C at week 32; percentage and absolute changes from baseline in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), total cholesterol/HDL-C ratio, ApoB/apolipoprotein A1 (ApoA1) ratio, lipoprotein(a) [Lp(a)] and triglycerides (TG) at weeks 16 and 32; proportion of patients whose hypercholesterolemia AEs return to normal at weeks 16 and 32; LDL-C target achievement rate at weeks 16 and 32; and safety profile related to recakimab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-group (Single-arm) interventional study: All enrolled subjects will receive recakimab 300 mg subcutaneous injection every 8 weeks.
| Arm | Type | Receives |
|---|---|---|
| Recakimab Treatment Arm | Experimental | Drug: Recaticimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years on the day of signing the informed consent form, with no gender restriction;
- Patients with unresectable stage IIIB/IIIC/IV non-small cell lung cancer (NSCLC) confirmed by cytology or histology (staging defined per the 9th edition of the International Association for the Study of Lung Cancer (IASLC) Staging Manual in Thoracic Oncology);
- Positive ALK fusion confirmed by genetic testing;
- Developed Grade 1-3 hypercholesterolemia adverse events after lorlatinib treatment (per CTCAE Version 5.0);
- Fasting triglyceride level ≤ 5.6 mmol/L at screening;
Key exclusion criteria (27 listed)
- Subjects with known hypersensitivity to the investigational product, or a history of severe hypersensitivity reactions to other antibody-based drugs;
- Diagnosed with familial hypercholesterolemia per the Simon Broome Criteria;
- Received other PCSK9 inhibitors within 6 months prior to screening;
- Uncontrolled hypercholesterolemia (total cholesterol above the upper limit of normal) existed before lorlatinib initiation;
- Prior diagnosis of New York Heart Association (NYHA) Class III-IV cardiac dysfunction;
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 |
|---|---|---|
| RecaticimabRecaticimab (SHR-1209) injection, a fully human monoclonal antibody targeting PCSK9. All eligible subjects will receive subcutaneous injection of recaticimab 300 mg once every 8 weeks during the treatment period. The administration cycle will be maintained up to 32 weeks. | Drug | Recakimab Treatment Arm |
Primary outcome
Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 16
Time frame: 16 weeks after treatment initiation
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 1 Jul 2026.
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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?
A Phase 4 study testing Recaticimab in people with ALK Fusion-positive Non-small Cell Lung Cancer, run by Hunan Cancer Hospital 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 6 inclusion and 27 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 1 Jul 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Xingxiang pu Pu (86-731-88651900, pxx_1354@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 16 (time frame: 16 weeks after treatment initiation). 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 1 Jul 2026.