Phase 3 Clinical Study of AK112 for NSCLC Patients
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ClinicalTrials.gov Identifier: NCT05184712 |
Recruitment Status :
Recruiting
First Posted : January 11, 2022
Last Update Posted : April 12, 2024
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Sponsor:
Summit Therapeutics
Collaborator:
Akeso
Information provided by (Responsible Party):
Summit Therapeutics
Tracking Information | |||||
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First Submitted Date ICMJE | December 21, 2021 | ||||
First Posted Date ICMJE | January 11, 2022 | ||||
Last Update Posted Date | April 12, 2024 | ||||
Actual Study Start Date ICMJE | January 1, 2022 | ||||
Estimated Primary Completion Date | January 1, 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
Progression-free survival (PFS) [ Time Frame: Up to 2 years ] Progression-free survival (PFS) assessed by IRC per RECIST v1.1 in the ITT population.
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase 3 Clinical Study of AK112 for NSCLC Patients | ||||
Official Title ICMJE | A Randomized, Double-blind, Multi-center, Phase III Study of AK112 or Placebo Combined With Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous NSCLC Who Have Failed to EGFR-TKI Treatment | ||||
Brief Summary | A Randomized, Double-blind, Multi-center, Phase III Clinical Study of Ivonescimab (SMT112 or AK112) or Placebo Plus Pemetrexed and Carboplatin in Patients With EGFR-mutant Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Who Have Progressed on or Following Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI) Treatment (HARMONi) | ||||
Detailed Description | 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 and Carboplatin in Patients with Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC) Harboring. Approximately 470 subjects will be randomized to two treatment arms at the ratio of 1:1. Each enrolled subject will receive an intravenous infusion of 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 treatment (administered on Day 1 of each cycle, Q3W) up to 2 years. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Non-Squamous Non-small Cell Lung Cancer | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
470 | ||||
Original Estimated Enrollment ICMJE |
320 | ||||
Estimated Study Completion Date ICMJE | January 1, 2026 | ||||
Estimated Primary Completion Date | January 1, 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada, China, France, Italy, Spain, United States | ||||
Removed Location Countries | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT05184712 | ||||
Other Study ID Numbers ICMJE | AK112-301 HARMONi ( Other Identifier: Summit Therapeutics ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Summit Therapeutics | ||||
Original Responsible Party | Akeso | ||||
Current Study Sponsor ICMJE | Summit Therapeutics | ||||
Original Study Sponsor ICMJE | Akeso | ||||
Collaborators ICMJE | Akeso | ||||
Investigators ICMJE |
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PRS Account | Summit Therapeutics | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |