NCT05899608 Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
| NCT ID | NCT05899608 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Summit Therapeutics |
| Condition | Non-Small Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,600 participants |
| Start Date | 2023-10-26 |
| Primary Completion | 2028-12-31 |
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 1,600 participants in total. It began in 2023-10-26 with a primary completion date of 2028-12-31.
⚠ 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
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years old at the time of enrollment * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Expected life expectancy ≥ 3 months * Metastatic (Stage IV) NSCLC * Histologically or cytologically confirmed squamous or non-squamous NSCLC * Recorded measurement of the Tumor Proportion Score (TPS) or Tumor Cells (TC) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization * 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 * Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available. * For non-squamous histology patients, actionable driver mutation testing results are required before randomization. * Has received any prior therapy for NSCLC in the metastatic setting * Tumor invasion, encasement of organs (e.g. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
Contact & Investigator
Indu Lal
STUDY DIRECTOR
Summit Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT05899608 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 NCT05899608 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 1,600 participants.
Is NCT05899608 currently recruiting?
Yes, NCT05899608 is actively recruiting participants. Contact the research team at medicalinformation@smmttx.com for enrollment information.
Where is the NCT05899608 trial being conducted?
This trial is being conducted at Phoenix, United States, Tucson, United States, Hot Springs, United States, Little Rock, United States and 11 additional locations.
Who is sponsoring the NCT05899608 clinical trial?
NCT05899608 is sponsored by Summit Therapeutics. The principal investigator is Indu Lal at Summit Therapeutics, Inc.. The trial plans to enroll 1,600 participants.
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