Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSummit Therapeutics

About this trial

Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.

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 - 1

Expected life expectancy ≥ 3 months

Metastatic (Stage IV) NSCLC

Disqualifiers

Histologic or cytopathologic evidence of the presence of small cell lung carcinoma for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.

Has received any prior therapy for NSCLC in the metastatic setting.

Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.

Known actionable genomic alterations for which first-line approved therapies are indicated

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ivonescimab Injection

    Biological/Vaccine

    Subject will receive ivonescimab as an IV injection

  • Pembrolizumab Injection

    Biological/Vaccine

    Subject will receive Pembrolizumab as an IV injection

Treatment groups

780 Participants
are divided into 2 treatment groups
Group A: Arm A - IvonescimabExperimental treatment 1 intervention
Group B: Arm B - PembrolizumabActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time frame
Up to approximately 36 months
2

Progression free survival (PFS)

Time frame
Up to approximately 36 months

Secondary outcomes

1

Objective response rate (ORR)

Time frame
Up to approximately 36 months
2

Disease control rate ( DCR)

Time frame
Up to approximately 36 months
3

Duration of response (DoR)

Time frame
Up to approximately 36 months
4

Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results

Time frame
[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 approximately 24 months.

Other outcomes

Sponsors and contacts

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