Health Trials

Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients

ConditionNon-Small Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSummit Therapeutics

About this trial

This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old at the time of enrollment

Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

Expected life expectancy ≥ 3 months

Metastatic (Stage IV) NSCLC

Disqualifiers

Histologic or cytopathologic evidence of the presence of small cell lung carcinoma

Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.

For non-squamous histology patients, actionable driver mutation testing results are required before randomization.

Has received any prior therapy for NSCLC in the metastatic setting

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab Injection

    Biological/Vaccine

    Subject will receive ivonescimab and chemotherapy as an IV injection

  • Pembrolizumab Injection

    Biological/Vaccine

    Subject will receive pembrolizumab and chemotherapy as an IV injection

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: Arm A - Ivonescimab and chemotherapyExperimental treatment 1 intervention
Group B: Arm B - Pembrolizumab and chemotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Overall Survival (OS) in the ITT population

Time frame
approximately 4 years
2

Progression Free Survival (PFS)

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

Time frame
approximately 3 years

Secondary outcomes

1

Adverse Event (AE)

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

Time frame
From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, up to 2 years.

Other outcomes

Sponsors and contacts

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Summit Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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