Clinical trial · Interventional
AK112 in Combination With Chemotherapy in Advanced Squamous Non-Small Cell Lung Cancer
A Randomized, Controlled, Multi-center Phase III Clinical Study of AK112 Combined With Chemotherapy Versus PD-1 Inhibitor Combined With Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Squamous Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Squamous Non Small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK112, Carboplatin, Paxlitaxel | Drug | — | UNRESOLVED |
| Tislelizumab, Carboplatin, Paxlitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: AK112 in Combination With Paclitaxel Plus Carboplatin
- description
- 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.
- interventionNames
- Drug: AK112, Carboplatin, Paxlitaxel
- type
- ACTIVE_COMPARATOR
- label
- Active Comparator: Tislelizumab in Combination With Paclitaxel Plus Carboplatin
- description
- 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.
- interventionNames
- Drug: Tislelizumab, Carboplatin, Paxlitaxel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * ≥18 years old and ≤75 years old (at the time consent is obtained). * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Has a life expectancy of at least 3 months. * Has a histologically confirmed diagnosis of squamous NSCLC. * Has Stage IIIB/C or IV NSCLC (American Joint Committee on Cancer \[AJCC\]). * Has no prior systemic anti-tumor therapy for locally advanced or metastatic NSCLC. * Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Has adequate organ function. Exclusion Criteria: * Histological diagnosis of non-squamous NSCLC. * Has EGFR-sensitive mutations or ALK gene translocations. * Known ROS1 rearrangement, MET exon 14 skipping mutation, or RET gene fusion positivite. * Is currently participating in a study of an investigational agent or using an investigational device. * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment. * Has undergone major surgery within 30 days of Study Day 1. * Has known active central nervous system (CNS) metastases. * Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Has an active infection requiring systemic therapy. * Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). * History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Has received a live virus vaccine within 30 days of the planned first dose of study therapy. * Has any concurrent medical condition that, in the opinion of the Investigator, would complicate or compromise compliance with the study or the well-being of the subject.
References
Publications (2)
- DERIVEDChen 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;22(14):1637-1650. doi: 10.1080/14796694.2026.2676052. Epub 2026 Jun 3. PMID 42233228
- DERIVEDLu 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. PMID 42218899