Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05184712 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Phase 3 Clinical Study of AK112 for NSCLC Patients

StatusActive, Not Recruiting
PhasePhase 3
SponsorAkeso
Started2022-01-25
View on ClinicalTrials.gov ↗

Amendment history

2026-03-02
Study Status, Contacts/Locations v12
Primary completion dateestimated 2024-06-28→confirmed 2023-03-10
Completion date2025-11-02→2026-09
2024-06-24
Recruiting→Active, Not Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations v11
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-01-01→2024-06-28
Completion date2026-01-01→2025-11-02
Start date2022-01-01→2022-01-25
Enrollment targetestimated 470→confirmed 322
Study sites64→1
Lead sponsorSummit Therapeutics→Akeso
Eligibility criteria+124 characters
[...] ired for the study are performed. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. Eastern Coop [...] ivating mutations before enrollment Have previously received 3rd generation EGFR-TKI treatment and havethe progressedtreatment onhas or followingfailed Subjects have at least one measurable non-brain tumor lesio [...] omodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose. Tumor surrounds important blood vessels or has obvious nec [...]
Secondary endpoints8 to 9 entries
OS
Primary endpoints2 to 1 entries
Overall Survival (OS)
Study description-123 characters
The trial will be performed as a randomized, Double-Blind, Multicenter trial to compare Ivonescimab (SMT112 or AK112) Plus Pemetrexed and Carboplatin to Placebo Plus Pemetrexed [...] Non-Small Cell Lung Cancer (NSCLC) Harboring. Approximately 470320 subjects will be randomized to the two treatment arms at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of Ivonescimab (SMT112 orthe AK112)/Placebo Plus Pemetrexed and Carboplatin or Placebo Plus Pemetrexed and Carboplatin（Q3W,up to 4 cycles) ）in treatment periods per the randomization schedule. Afterward, Ivonescimab (SMT11 [...] [...]
Collaborators-5 characters
Akeso
2024-04-11
Study Status, Contacts/Locations v10
Study sites59→64
2024-03-11
Study Status, Contacts/Locations v9
Study sites46→59
2024-01-04
Study Status, Contacts/Locations v8
Study sites38→46
Show 7 earlier versions
2023-12-14
Study Status, Contacts/Locations v7
Study sites27→38
2023-11-02
Study Status, Contacts/Locations v6
Study sites16→27
2023-10-10
Study Status, Study Description, Arms and Interventions v5
InterventionsAK112 Injection (Drug), Placebo Injection (Drug)→Ivonescimab (SMT112 or AK112) Injection (Drug), Placebo Injection (Drug)
Study description+59 characters
The trial will be performed as a randomized, Double-Blind, Multicenter trial to compare Ivonescimab (SMT112/ or AK112) Plus Pemetrexed and Carboplatin to Placebo Plus Pemet [...] ch enrolled subject will receive an intravenous infusion of the Ivonescimab (SMT112/ or AK112)/ Plus Pemetrexed and Carboplatin or Placebo Plus Pemetrexed and Carboplatin（Q3W, up to 4 cycles）) in treatment periods per the randomization schedule. Afterward, Ivonescimab (SMT112/ or AK112)/ Plus Pemetrexed or Placebo Plus Pemetrexed will be used for maintenance treatm [...]
2023-05-23
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v4
Study sites1→16
Eligibility criteria-124 characters
[...] ired for the study are performed. Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent. Eastern Coop [...] ivating mutations before enrollment Have previously received 3rd generation EGFR-TKI treatment and thehave treatmentprogressed hason failedor following Subjects have at least one measurable non-brain tumor lesio [...] omodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose. Tumor surrounds important blood vessels or has obvious nec [...]
Study description+64 characters
The trial will be performed as a randomized, Double-Blind, Multicenter trial to compare Ivonescimab (SMT112/AK112) Plus Pemetrexed and Carboplatin to Placebo Plus Pemetrexed [...] Non-Small Cell Lung Cancer (NSCLC) Harboring. Approximately 320470 subjects will be randomized to the two treatment arms at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of the Ivonescimab (SMT112/AK112)/Placebo Plus Pemetrexed and Carboplatin （Q3W,up to 4 cycles [...] reatment periods per the randomization schedule. Afterward, Ivonescimab (SMT112/AK112)/ Placebo Plus Pemetrexed will be used for mai [...]
2023-04-25
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Outcome Measures, Contacts/Locations v3
Primary completion date2024-01-01→2025-01-01
Completion date2025-01-01→2026-01-01
Enrollment target320→470
Lead sponsorAkeso→Summit Therapeutics
Secondary endpoints9 to 8 entries
OS
Primary endpoints1 to 2 entries
Overall Survival (OS)
Collaborators1 entry, revised
Summit TherapeuticsAkeso
2022-12-08
Study Status, Sponsor/Collaborators v2
Collaborators+19 characters
Summit Therapeutics
2022-05-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2022-01-07
Original filing
A Randomized, Double-blind, Multi-center, Phase III Clinical Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Failed to Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment
Trial Details
NCT Number NCT05184712
Lead Sponsor Akeso
Conditions Non-Squamous Non-small Cell Lung Cancer
Enrollment 322 participants
Start Date 2022-01-25
Primary Completion 2023-03-10 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-03-04