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โ† Trials
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Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer

RecruitingPhase 3Ages 18 Years - 75 YearsAllAkeso
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In plain words

What the trial is, and whether it could suit you

This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures). * Age โ‰ฅ 18 years old and โ‰ค 75 years old at the time of randomization. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Expected life expectancy of at least 3 months. * Histologically or cytologically confirmed diagnosis of NSCLC. * Locally advanced or metastatic NSCLC (American Joint Committee on Cancer \[AJCC\] 8th edition). * Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors. * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. * Adequate organ function. Exclusion Criteria: * Histologic or cytopathologic evidence of the presence of small cell lung carcinoma. * Other malignancies within 3 years prior to randomization. * Known actionable genomic alterations. * Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors. * Previous treatment with docetaxel. * History of severe bleeding tendency or coagulation dysfunction. * Active autoimmune disease requiring systemic therapy within 2 years prior to randomization. * History of myocarditis, cardiomyopathy, and malignant arrhythmia.
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What it tests

  • Ivonescimab, docetaxel
  • Placebo, docetaxel
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Where

1 site
Shanghai East Hospital
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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