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Taking people in ChinaPhase 2

AK146D1 combined with AK112 for advanced non-small cell lung cancer

Tests AK146D1 with AK112 in adults with advanced non-small cell lung cancer.

Key facts

Who runs it
Akeso
Where
Guangzhou, ChinaSee the site
Trial code
Registry title
A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer
Status
Recruiting
Phase
Phase 2
People taking part
348 people, planned
Started
10 Jul 2026
Expected to end
30 May 2029
Type of study
Interventional, 3 groups
Treatments tested
  • AK146D1 for injection
  • AK112 Injection
  • Platinum chemotherapy
  • Osimertinib
Record updated
14 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 75 with advanced non-small cell lung cancer that cannot be removed by surgery and cannot be treated with full chemoradiotherapy.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Non-small cell lung cancer, locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV), confirmed by tissue or cell tests. Surgery to remove all the disease and full chemoradiotherapy are not possible. At least one measurable lesion outside the brain.
Earlier treatment
No earlier treatment aimed at Trop2 or Nectin4. No earlier chemotherapy or antibody-drug conjugate therapy aimed at topoisomerase I inhibitors. No systemic anti-tumor therapy in the 4 weeks (or 5 half-lives of the drug, whichever is longer) before the first dose.

Main reasons for not taking part

  • Lung cancer mixed with small cell lung cancer, neuroendocrine carcinoma or carcinosarcoma
  • Other active cancer within 3 years
  • Active cancer spread to the central nervous system (stable or symptom-free brain metastases can join)
  • Known HIV or other infections
  • Active autoimmune disease needing systemic treatment within 2 years

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

  • Be able to understand and voluntarily sign the written informed consent form
  • Aged of ≥ 18 years and ≤75 years
  • ECOG PS 0 or 1
  • The expected lifespan is ≥3 months
  • 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
  • At least one measurable non-brain lesion according to RECIST v1.1
  • Have sufficient organ function
  • Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception

Who cannot take part

  • Having received any treatment targeting Trop2 or Nectin4
  • Prior chemotherapy or antibody-drug conjugate (ADC) therapy targeting topoisomerase I inhibitors
  • 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
  • Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower
  • Receipt of systemic anti-infective therapy within 2 weeks prior to the first dose
  • Previous history of severe hypersensitivity reactions
  • Live attenuated vaccines were received within 4 weeks
  • NSCLC mixed with a component of small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma
  • Having other active malignancies within 3 years
  • Subjects with clinically significant cardiovascular or cerebrovascular diseases or risks
  • Subjects with active autoimmune diseases requiring systemic treatment within 2 years
  • Known to be positive for HIV and other infections
  • Subjects with a history of mental illness and incapacitated or limited capacity
  • Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments
  • Currently participating in another interventional clinical study
  • Presence of active metastases to the central nervous system. For patients with asymptomatic brain metastasis or stable symptoms after treatment can be included

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • SunYat-sen University Cancer CenterGuangzhou, ChinaContact: Li ZhangTaking people

About the trial

What the trial wants to find out

This is a phase II clinical study evaluating the safety, tolerability, pharmacokinetics and antitumor efficacy of AK146D1 in combination with AK112 or other anticancer therapies in patients with advanced Non-Small Cell Lung Cancer.

The 3 groups in the trial

  • Arm ATreatment being tested

    Participants in this group will receive AK146D1 combined with AK112 and platinum as i.v. infusion.

    Treatment: AK146D1 for injection, AK112 Injection, and Platinum chemotherapy

  • Arm BTreatment being tested

    Participants in this group will receive AK146D1 combined with osimertinib.

    Treatment: AK146D1 for injection and Osimertinib

  • Arm CTreatment being tested

    Participants in this group will receive AK146D1 combined with AK112 as i.v. infusion.

    Treatment: AK146D1 for injection and AK112 Injection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antitumor Efficacy of AK146D1 in Combination With AK112 or Other Anticancer Therapies in Patients With Advanced Non-Small Cell Lung Cancer
Plain-language title
AK146D1 combined with AK112 for advanced non-small cell lung cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07669779, who can take part
Record updated
14 July 2026