Clinical trial · Interventional
Ivonescimab in Combination With Docetaxel in Advanced Non-Small Cell Lung Cancer
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
- 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 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.
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 |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ivonescimab, docetaxel | Drug | — | UNRESOLVED |
| Placebo, docetaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ivonescimab and docetaxel
- interventionNames
- Drug: Ivonescimab, docetaxel
- type
- ACTIVE_COMPARATOR
- label
- Placebo and docetaxel
- interventionNames
- Drug: Placebo, docetaxel
Primary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- approximately 5 years
- description
- Overall Survival (OS) in the FAS population
Secondary outcomes (2)
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). * 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.
References
Publications (0)
Data not yet available