NCT06767514 Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients With High PD-L1
| NCT ID | NCT06767514 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Summit Therapeutics |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 780 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 780 participants in total. It began in 2025-02-27 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06767514 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Non-Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06767514 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 780 participants.
Is NCT06767514 currently recruiting?
Yes, NCT06767514 is actively recruiting participants. Contact the research team at medicalinformation@smmttx.com for enrollment information.
Where is the NCT06767514 trial being conducted?
This trial is being conducted at Chandler, United States, Phoenix, United States, Hot Springs, United States, Cerritos, United States and 11 additional locations.
Who is sponsoring the NCT06767514 clinical trial?
NCT06767514 is sponsored by Summit Therapeutics. The trial plans to enroll 780 participants.
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