Drug duo aims to tackle tough lung cancers after first treatment fails
NCT ID NCT07703228
First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time
Summary
This trial tests whether combining sacituzumab tirumotecan (a targeted antibody-drug conjugate) with anlotinib (a multi-targeted pill) can shrink tumors or slow cancer growth in people with advanced non-squamous non-small cell lung cancer that has no known driver gene mutations. Participants receive both drugs after their first-line immunotherapy and chemotherapy stopped working. The study also looks for biomarkers in blood that might predict who benefits most.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of sacituzumab tirumotecan (an antibody-drug conjugate targeting TROP2) and anlotinib (a multi-target tyrosine kinase inhibitor)
- What this could lead to
- If successful, this combination could offer a new second-line treatment option for people with advanced non-squamous lung cancer who have no targetable gene mutations.
- What could go wrong
- This is a small, early-phase single-arm study without a control group, so results may not be definitive. Side effects from the drug combination could be significant.
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 38 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Mar 2028
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. Age ≥18 years, regardless of gender. 2. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-squamous NSCLC, progressing after prior anti-PD-1/L1 monoclonal antibody combined with platinum-based doublet chemotherapy. 3. No known driver gene alterations such as EGFR, ALK, ROS1, NTRK, BRAF, MET, KRAS, HER2, RET, etc. 4. At least one measurable target lesion not previously irradiated, assessed by the investigator per RECIST v1.1. 5. ECOG performance status score of 0 or 1. 6. Asymptomatic or locally treated and stable brain metastases are allowed. 7. Life expectancy ≥ 12 weeks. 8. Adequate organ and bone marrow function. 9. Agreement to use effective medical contraception from signing informed consent until 6 months after the last dose. 10. Voluntary participation, signed informed consent, and ability to comply with the protocol. Exclusion Criteria: 1. Tumors histologically or cytologically confirmed with mixed small cell lung cancer, squamous cell carcinoma, neuroendocrine carcinoma, or carcinosarcoma components. 2. Prior treatment with TROP2-targeted therapy or any drug targeting topoisomerase I (including ADCs). 3. Known meningeal, brainstem, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases. 4. Other malignancies within 3 years prior to dosing (except locally cured tumors like basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.). 5. Presence of major cardiovascular diseases or risk factors within 6 months prior to dosing (e.g., myocardial infarction, severe arrhythmias, active myocarditis, major vascular disease requiring surgery). 6. Poorly controlled hypertension (systolic \> 160 mmHg and/or diastolic \> 100 mmHg). 7. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, or current active/suspected ILD/pneumonitis. 8. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or corneal disease preventing/delaying healing. 9. Active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding. 10. Risk of esophageal-tracheal or esophageal-pleural fistula. 11. Tumors invading major blood vessels or high risk of fatal bleeding. 12. Bleeding symptoms or any ≥CTCAE grade 3 bleeding event with unhealed wounds, ulcers, or fractures within 1 month prior to first dose. 13. Known active tuberculosis. 14. History of allogeneic organ transplant or allogeneic hematopoietic stem cell transplant. 15. HIV positive, history of AIDS, or active syphilis infection. 16. Major surgery within 4 weeks prior to dosing or planned major surgery during the study. 17. Current use of strong CYP3A4 inducers (must be avoided at least 3 weeks prior). 18. Live vaccine within 30 days prior to dosing or planned during the study. 19. Pregnant or lactating women. 20. Any condition that, in the investigator's opinion, interferes with the evaluation of the study drug or compromises subject safety.
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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.
Contacts and locations
Locations
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Two-Drug combo outsmart tough lung cancer?
- Can a new Antibody-Drug conjugate outsmart advanced lung cancer?
- Experimental pill SHY-ONC6 takes on Hard-to-Treat cancers
- Blood test may let cancer patients take safe breaks from immunotherapy
- New combo aims to stall lung cancer when targeted pills start to fail
- New hope for lung cancer patients: drug combo targets tough tumors