New drug cocktail targets tough lung cancer
NCT ID NCT07669779
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This phase 2 trial tests a new drug called AK146D1, given together with other cancer drugs, in 348 people with advanced non-small cell lung cancer that cannot be surgically removed. The study aims to see if the combination is safe and can shrink tumors. Participants will receive the drugs by injection or infusion, and researchers will monitor side effects and how long the cancer stays under control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AK146D1 (a bispecific antibody-drug conjugate targeting Trop2 and Nectin4) combined with AK112 (a bispecific antibody targeting PD-1 and VEGF) or other anticancer drugs
- What this could lead to
- If successful, this could provide a new treatment option for advanced non-small cell lung cancer that has not responded to other therapies.
- What could go wrong
- This is an early phase 2 trial, so the combination may not prove effective or safe enough for wider use. Side effects from the drug combination are possible and being studied.
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 348 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 to 75 years
- 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. Be able to understand and voluntarily sign the written informed consent form. 2. Aged of ≥ 18 years and ≤75 years. 3. ECOG PS 0 or 1. 4. The expected lifespan is ≥3 months. 5. Patients with histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) who are not eligible for curative surgical resection and cannot receive definitive concurrent or sequential chemoradiotherapy. 6. At least one measurable non-brain lesion according to RECIST v1.1. 7. Have sufficient organ function. 8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception. Exclusion Criteria: 1. NSCLC mixed with a component of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma. 2. Having other active malignancies within 3 years. 3. Currently participating in another interventional clinical study. 4. Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included. 5. Having received any treatment targeting Trop2 or Nectin4. 6. Prior chemotherapy or antibody-drug conjugate (ADC) therapy targeting topoisomerase I inhibitors. 7. Receipt of systemic anti-tumor therapy (including chemotherapy, immunotherapy, biological agents, etc.) within 4 weeks (or 5 half-lives of the drug, whichever is longer) prior to the first dose. 8. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower. 9. Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks. 10. Subjects with active autoimmune diseases requiring systemic treatment within 2 years. 11. Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose. 12. Known to be positive for HIV and other infections. 13. Previous history of severe hypersensitivity reactions. 14. Live attenuated vaccines were received within 4 weeks. 15. Subjects with a history of mental illness and incapacitated or limited capacity. 16. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments.
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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SunYat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, China
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