RightFit
RecruitingPhase 3

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

A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ivonescimab as the first treatment for non-small cell lung cancer (NSCLC) that has spread to other parts of the body. It is for adults whose tumors have high levels of a protein called PD-L1. The study looks at how long people live and how long they live without the cancer getting worse.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older and are expected to live at least 3 months.
  • You are fully active or can do light work despite some limits on physical activity (ECOG score 0–1).
  • You have stage IV NSCLC, meaning it has spread to other parts of the body.
  • A tissue or cell test confirms squamous or non-squamous NSCLC, the two types allowed in this study.
  • An approved 22C3 test shows PD-L1 on more than 50% of your tumor cells.
  • You have at least one tumor outside the brain that can be measured using the study’s rules.
  • You have not had treatment that acts throughout the body for metastatic NSCLC.
  • If you have non-squamous NSCLC, results from testing for cancer-driving gene changes must be available before you are assigned to a study group.

Who can't join

  • You have small cell lung cancer or a known cancer gene change for which an approved first treatment is available.
  • You have already had any treatment for NSCLC after it spread to other parts of the body.
  • You are in another clinical study, unless it only observes your health or is only following how long you live.
  • Cancer in your brain or spinal cord causes symptoms or is at least 1.5 cm wide; you had radiation there within 7 days before group assignment; you may need radiation there during the first treatment cycle; or cancer has spread to the lining around your brain or spinal cord.
  • You had another cancer, including earlier NSCLC, unless treatment aimed to cure it and it has not returned for 3 years before group assignment.
  • You have active autoimmune disease (when the immune system attacks the body) or lung disease needing treatment throughout the body; past lung inflammation not caused by infection that needed steroid treatment throughout the body; or current interstitial lung disease, which affects tissue around the lung’s air sacs.
  • You have existing nerve damage outside the brain and spinal cord rated grade 2 or higher on the study’s scale.
  • You had a severe infection, major surgery, or serious injury within 4 weeks before group assignment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 * Histologically or cytologically confirmed squamous or non-squamous NSCLC * Tumor demonstrates high PD-L1 expression ( TPS\>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities. * At least one measurable noncerebral lesion according to RECIST 1.1 * No prior systemic treatment for metastatic NSCLC. Exclusion Criteria: * 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 * Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease * Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization * Active autoimmune or lung disease requiring systemic therapy * Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5 * Severe infection within 4 weeks prior to randomization * Major surgical procedures or serious trauma within 4 weeks prior to randomization * History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease

Study sites (97)

AR

AZ

CA

CO

FL

GA

IA

IL

IN

KY

LA

MA

MD

MI

MN

MO

MS

NC

NH

NJ

NY

OH

OK

OR

PA

SC

TN

TX

UT

VA

WA