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

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab, docetaxel

    Drug

    Patients will receive ivonescimab and docetaxel as an IV injection

  • Placebo, docetaxel

    Drug

    Patients will receive placebo and docetaxel as an IV injection

Treatment groups

536 Participants
are divided into 2 treatment groups
Group A: Ivonescimab and docetaxelExperimental treatment 1 intervention
Group B: Placebo and docetaxelActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Overall Survival (OS) in the FAS population

Time frame
approximately 5 years

Secondary outcomes

1

Progression Free Survival (PFS)

Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1

Time frame
approximately 3 years
2

Adverse Event (AE)

Incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

Time frame
From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Akeso

Lead sponsor

Source ClinicalTrials.gov
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