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NCT06928389 | NOT YET RECRUITING | Non-Small Cell Lung Cancer

Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
Sponsor:

Akeso

Brief Summary:

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.

Condition or disease

Non-Small Cell Lung Cancer

Intervention/treatment

Ivonescimab, docetaxel

Placebo, docetaxel

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 536 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
Official Title : A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab 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
Actual Study Start Date : 2025-06
Estimated Primary Completion Date : 2027-05
Estimated Study Completion Date : 2030-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 ≥ 18 years old and ≤ 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.
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer

Location Details

NCT06928389

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Locations

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