First-line treatment for metastatic lung cancer patients with high PD-L1 using ivonescimab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study evaluates the effectiveness of ivonescimab as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) who have high levels of PD-L1 expression. The study aims to assess overall survival and progression-free survival in this patient population. Participants must be adults with confirmed metastatic NSCLC and no prior systemic treatment for their condition. The study will compare the outcomes of ivonescimab to pembrolizumab, another treatment option.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinical Study Site
  Chandler, Arizona, United States Recruiting
• Clinical Study Site
  Phoenix, Arizona, United States Recruiting
• Clinical Study Site
  Hot Springs, Arkansas, United States Recruiting
• Clinical Study Sites
  Jonesboro, Arkansas, United States Recruiting
• Clinical Study Site
  Alameda, California, United States Recruiting
• Clinical Study Site
  Anaheim, California, United States Recruiting

+235 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Summit Clinical Trial Information
• Email: medicalinformation@smmttx.com
• Phone: 1-833-256-0522

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• Chidamide plus Ivonescimab for advanced NSCLC with immune resistance and high YAP

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.