Trial NCT06767514
Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
- Phase
- Phase 3
- Sponsor
- Summit Therapeutics
- Conditions
- Non-Small Cell Lung Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
* Age ≥ 18 years old at the time of enrollment
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 - 1Performance status
* 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 diseaseBrain metastases
* 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 randomizationPrior malignancy
* 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
Restrictions found (3)
- Brain metastasesConditionalexclusion
CNS metastasis ≥ 1.5 cm; CNS radiation within 7 days
Show in the text - Performance statusOutrightinclusion
ECOG 0-1
Show in the text - Prior malignancyConditionalexclusion
within 3 years
Show in the text
Recruiting in Massachusetts
- Clinical Study Site · Boston, Suffolk County
- Clinical Study Site · Brighton, Suffolk County
- Clinical Study Site · Foxborough, Norfolk County
- Clinical Study Site · Methuen, Essex County
- Clinical Study Site · Milford, Worcester County
- Clinical Study Site · Weymouth, Norfolk County
- Clinical Study Site · Worcester, Worcester County