Can a drug duo outsmart ALK-Positive lung cancer?
NCT ID NCT07750704
First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This trial is testing whether combining two targeted therapies—lorlatinib and sacituzumab tirumotecan—can better control advanced ALK-positive non-small cell lung cancer when used as the first treatment. The study involves about 153 adults with locally advanced or metastatic disease who have not yet received systemic therapy. Researchers will also use a blood test (ctDNA) to guide treatment decisions. The main goal is to see how long the cancer stays under control after one year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lorlatinib combined with sacituzumab tirumotecan
- What this could lead to
- If successful, this combination could become a new first-line treatment option for ALK-positive lung cancer, potentially improving how long the cancer is kept under control.
- What could go wrong
- This is an early-phase trial, so the combination may not work better than existing treatments or may cause unexpected side effects. The results are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 153 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged ≥ 18 years at the time of signing the informed consent, regardless of gender; 2. Histologically/cytologically confirmed NSCLC, Stage III (locally advanced) or IV (metastatic), unsuitable for curative surgery and/or curative radiotherapy, with or without prior concurrent/sequential chemotherapy; 3. No prior systemic therapy for locally advanced or metastatic NSCLC, patients previously treated with curative-intent adjuvant/neoadjuvant chemo or concurrent/sequential chemoradiotherapy for non-metastatic disease are eligible if progression occurred ≥ 12 months after the last treatment; 4. Confirmation of ALK fusion by tumor histology, cytology, or blood-based testing; 5. Patients must have at least one measurable lesion according to RECIST v1.1. Lesions that have been previously irradiated should not be selected as target lesions. Subjects with only skin lesions or bone lesions are not eligible for inclusion; 6. ECOG performance status score of 0 or 1 within 7 days prior to the first dose of study drug; 7. Estimated survival of ≥ 12 weeks; 8. Adequate organ and bone marrow function, without having received blood transfusion, recombinant human thrombopoietin, or colony-stimulating factors within 2 weeks prior to the first dose of study drug. Exclusion Criteria: 1. Histological or cytological confirmation of mixed small cell lung cancer, neuroendocrine carcinoma, carcinosarcoma, or squamous cell carcinoma components; 2. Prior receipt of any of the following therapies (including in the adjuvant or neoadjuvant setting): a) TROP2-targeted therapy; b) Any therapy containing topoisomerase I, including antibody-drug conjugate (ADC) therapy; c) Lorlatinib targeted therapy; 3. Presence of factors affecting oral drug administration; 4. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that precludes or delays corneal healing; 5. Presence of spinal cord compression. Subjects who have received adequate local treatment (surgery or radiotherapy) and have clinical evidence of symptom relief for ≥ 1 week prior to the first dose may be enrolled; 6. Presence of active central nervous system (CNS) metastases. Subjects with stable asymptomatic CNS metastases may be enrolled; 7. Presence of other malignancy within 3 years prior to the first dose (except for tumors cured by local therapy or in situ carcinomas that do not require immediate treatment); 8. Presence of severe cardiovascular or cerebrovascular disease or cardiovascular risk factors; 9. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid therapy, current ILD or non-infectious pneumonitis, or suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; 10. Prior antitumor therapy-related toxicities have not recovered to ≤ grade 1 (based on NCI CTCAE v5.0) or to the levels specified in the eligibility criteria (excluding toxicities deemed by the investigator to be of low safety risk, such as alopecia, fatigue, or peripheral neuropathy); 11. Active hepatitis B (hepatitis B surface antigen \[HBsAg\] positive, requiring HBV-DNA testing; HBV-DNA ≥ 2000 IU/mL or above the lower limit of detection, whichever is higher) or hepatitis C (positive for hepatitis C antibody with HCV-RNA above the lower limit of detection).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Guangdong Provincial Perople's Hospital
Guangzhou, Guangdong, China
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- New hope for ALK lung cancer: first human trial of AQUA07 begins
- Real-World data reveals how lung cancer drug lorlatinib performs outside the lab