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This trial is a Phase III study. All patients are stage IIIB/C (unsuitable for radical therapy) or stage IV squamous non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 combined with chemotherapy versus Tislelizumab combined with chemotherapy in patients with advanced squamous NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin | Experimental | AK112 will be administered at a selected dose intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles. |
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| Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin | Active Comparator | Tislelizumab will be administered at a dose of 200 mg intravenously (IV) every three weeks (Q3W). Carboplatin will be administered at AUC5, Q3W, intravenously (IV) for 4 cycles. Paclitaxel will be administered at 175 mg/m2, Q3W, intravenously (IV) for 4 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK112, Carboplatin, Paxlitaxel | Drug | IV infusion,Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by IRRC per RECIST v1.1 | Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression (per RECIST v1.1 criteria) assessed by the blinded IRRC or death due to any cause (whichever occurs first). | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| OS | Overall Survival (OS) is defined as the time from the start of treatment with AK112 until death due to any cause. | Up to approximately 2 years |
| ORR assessed by IRRC per RECIST v1.1 | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42233228 | Derived | Chen Z, Yang F, Jiang Z, Sun L, Wu L, Han Z, Fan Y, Zhao Y, Li X, Xu H, Meng X, Liu Y, Zhang Z, Luo H, Ma X, Ma X, Shi Q, Zhang Z, Yang R, Wang P, Pan P, Ai X, Li J, Pu X, Wang Z, Fang J, He M, He Y, Guo S, Li J, Wang H, Zhang J, Chu Q, Liu X, Ying S, Wu H, Sun H, Ji Y, Zhou M, Cao C, Tang K, Li Z, Li D, Zhang Z, Li J, Zhou J, Yang H, Du Y, Yang H, Shi J, Chen H, Moore AC, Lu S. Plain language summary: comparing ivonescimab plus chemotherapy with tislelizumab plus chemotherapy in people with advanced squamous non-small cell lung cancer in the HARMONi-6 study. Future Oncol. 2026 Jun 3:1-14. doi: 10.1080/14796694.2026.2676052. Online ahead of print. | |
| 42218899 |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| C000707970 | tislelizumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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| Tislelizumab, Carboplatin, Paxlitaxel | Drug | IV infusion,Specified dose on specified days |
|
| Up to approximately 2 years |
| DoR assessed by IRRC per RECIST v1.1 | Duration of response (DoR) assessed according to RECIST v1.1 | Up to approximately 2 years |
| DCR assessed by IRRC per RECIST v1.1 | Disease control rate (DCR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| TTR assessed by IRRC per RECIST v1.1 | Time to response (TTR) is defined as the time to response base on RECIST v1.1. | Up to approximately 2 years |
| PFS assessed by investigator per RECIST v1.1 | Progression-free survival (PFS) is defined as the time from the date of randomization till the first documentation of disease progression assessed by the investigator or death due to any cause (whichever occurs first). | Up to approximately 2 years |
| ORR assessed by the investigator per RECIST v1.1 | ORR is the proportion of subjects with complete response(CR) or partial response(PR) , based on RECIST v1.1. | Up to approximately 2 years |
| DoR assessed by the investigator per RECIST v1.1 | Duration of response (DoR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| DCR assessed by the investigator per RECIST v1.1 | Disease control rate (DCR) assessed according to RECIST v1.1. | Up to approximately 2 years |
| TTR assessed by the investigator per RECIST v1.1 | Time to response (TTR) is defined as the time to response base on RECIST v1.1. | Up to approximately 2 years |
| AE | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. | Up to approximately 2 years |
| ADA | Number of subjects with detectable anti-drug antibodies (ADA). | Up to approximately 2 years |
| Cmax and Cmin | AK112 serum drug concentrations in subjects at different time points after AK112 administration | Up to approximately 2 years |
| PD-L1 expression | The correlationship between PD-L1 expression and efficacy. | Up to approximately 2 years |
| Derived |
| Lu S, Liu B, Luo Y, Sun L, Wu L, Han Z, Fan Y, Zhao Y, Li X, Xu H, Meng X, Liu Y, Zhang Z, Luo H, Ma X, Ma X, Shi Q, Zhang Z, Yang R, Wang P, Pan P, Ai X, Li J, Pu X, Wang Z, Fang J, He M, He Y, Guo S, Li J, Wang H, Zhang J, Chu Q, Liu X, Ying S, Wu H, Sun H, Ji Y, Zhou M, Cao C, Tang K, Li Z, Li D, Zhang Z, Li J, Zhou J, Yang H, Du Y, Yang H, Shi J, Chen H, Chen Z, Li W, Lu D, Hu M, Wang ZM, Li B, Xia MY. Ivonescimab plus chemotherapy versus tislelizumab plus chemotherapy in advanced squamous non-small-cell lung cancer (HARMONi-6): interim overall survival analysis of a randomised, double-blind, phase 3 trial in China. Lancet. 2026 Jun 27;407(10548):2620-2629. doi: 10.1016/S0140-6736(26)00966-9. Epub 2026 May 31. |