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NCT05215067

A Phase II Trial of AK104 in Advanced Non-Small Cell Lung Cancer

Active, enrolled Phase 2 Last updated 12 March 2025
What this trial tests

Phase 2 trial testing AK104 in Advanced Non-small Cell Lung Cancer in 44 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
9 March 2022
Primary endpoint
30 June 2025
30 June 2026

Quick facts

Lead sponsorAkeso
PhasePhase 2
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment44
Start date9 March 2022
Primary completion30 June 2025
Estimated completion30 June 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Akeso — full company profile →

Who can join

Adults 18 to 75, any sex, with Advanced Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase II open label, multicenter study to evaluate the efficacy and safety of AK104 (anti-PD-1 and CTLA-4 bispecific antibody) combined with Docetaxel in Advanced Non-Small Cell Lung Cancer whose disease has progressed after prior platinum doublet chemotherapy and anti-PD-1/PD-L1 monoclonal antibody

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Signaling pathways and targeted therapies in lung squamous cell carcinoma: mechanisms and clinical trials.
    Niu Z, Jin R, Zhang Y, Li H. · · 2022 · cited 127× · PMID 36198685 · DOI 10.1038/s41392-022-01200-x
  2. Dual blockade immunotherapy targeting PD-1/PD-L1 and CTLA-4 in lung cancer.
    Cheng W, Kang K, Zhao A, Wu Y. · · 2024 · cited 110× · PMID 39068460 · DOI 10.1186/s13045-024-01581-2
  3. Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question.
    Ordóñez-Reyes C, Garcia-Robledo JE, Chamorro DF, Mosquera A, et al · · 2022 · cited 22× · PMID 35745815 · DOI 10.3390/pharmaceutics14061243
  4. Targeting tumor microenvironment for non-small cell lung cancer immunotherapy.
    Wang L, Jia Q, Chu Q, Zhu B. · · 2023 · cited 16× · PMID 39170874 · DOI 10.1016/j.pccm.2022.11.001
  5. Advances in the Lung Cancer Immunotherapy Approaches.
    Padinharayil H, Alappat RR, Joy LM, Anilkumar KV, et al · · 2022 · cited 9× · PMID 36423060 · DOI 10.3390/vaccines10111963
  6. Current Indications and Future Landscape of Bispecific Antibodies for the Treatment of Lung Cancer.
    Arasanz H, Chocarro L, Fernández-Rubio L, Blanco E, et al · · 2023 · cited 6× · PMID 37373003 · DOI 10.3390/ijms24129855
  7. Application and future prospects of bispecific antibodies in the treatment of non-small cell lung cancer.
    Wen J, Cui W, Yin X, Chen Y, et al · · 2025 · cited 5× · PMID 40192238 · DOI 10.20892/j.issn.2095-3941.2024.0470
  8. Unveiling the Synergistic Potential: Bispecific Antibodies in Conjunction with Chemotherapy for Advanced Non-Small-Cell Lung Cancer Treatment.
    Khan SR, Breadner D. · · 2025 · cited 4× · PMID 40277763 · DOI 10.3390/curroncol32040206

Verify or expand the search:

Other trials of AK104

Trials testing the same drug.

Other recruiting trials for Advanced Non-small Cell Lung Cancer

Currently open trials in the same condition.

Other Akeso trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05215067.

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