Ivonescimab + Radiosurgery for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the safest and most effective dose of a new drug, ivonescimab, when combined with chemotherapy and targeted brain radiation (stereotactic radiosurgery) for treating non-small cell lung cancer that has metastasized to the brain. Researchers will first test various doses to identify those with the fewest side effects, then evaluate the chosen dose's effectiveness against brain tumors. Individuals with non-small cell lung cancer that has spread to the brain and who have not received certain immunotherapies may be suitable candidates for this trial. As a Phase 1/Phase 2 trial, this research focuses on understanding the treatment's effects in people and assessing its effectiveness in an initial, smaller group, offering participants the opportunity to be among the first to benefit from this innovative approach.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ivonescimab, a treatment for non-small cell lung cancer (NSCLC), yields promising results in safety and effectiveness. Patients using ivonescimab have experienced improved quality of life and health outcomes. However, some patients reported serious side effects, with 29% experiencing significant adverse reactions.
For stereotactic radiosurgery (SRS), which targets cancer that has spread to the brain, research suggests it is generally well-tolerated. Most patients report only mild side effects, with serious side effects occurring in about 11% of cases. This method effectively focuses radiation on cancer cells without harming nearby healthy tissue.
Overall, previous studies have shown both ivonescimab and SRS to be safe, though some side effects can occur. Clinical trial participants are closely monitored to manage any adverse effects.12345Why are researchers excited about this trial's treatments for non-small cell lung cancer?
Unlike the standard treatments for non-small cell lung cancer, which often involve chemotherapy and traditional radiation, ivonescimab is unique because it combines with stereotactic radiosurgery to precisely target brain metastases. This approach uses an advanced form of radiation therapy, delivering high doses directly to the tumor while sparing surrounding healthy tissue. Researchers are excited about ivonescimab's potential to enhance the effectiveness of radiosurgery, potentially leading to better outcomes with fewer side effects. Additionally, the treatment's novel mechanism of action, which may work synergistically with chemotherapy, offers a promising new avenue for tackling tough-to-treat cancer metastases.
What evidence suggests that ivonescimab combined with stereotactic radiosurgery could be effective for non-small cell lung cancer with brain metastases?
Research has shown that ivonescimab, when combined with chemotherapy, yields promising results for patients with advanced non-small cell lung cancer (NSCLC). It extends the time patients live without their cancer worsening and reduces the risk of cancer spreading to the brain. In this trial, participants will receive ivonescimab with chemotherapy and stereotactic radiosurgery (SRS). Studies have found that ivonescimab with chemotherapy benefits patients both with and without brain cancer spread, helping them avoid new or growing brain tumors. Additionally, SRS effectively controls brain cancer spread in NSCLC patients, especially those with fewer than four brain tumors, and improves their overall survival. Together, these treatments offer hope for managing brain cancer spread in NSCLC patients.678910
Who Is on the Research Team?
Luke Pike, M.D., PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Phase I
Participants receive ivonescimab at a starting dose of 10 mg/kg on Day 1 with chemotherapy, followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10. A toxicity check is performed at Day 21.
Treatment Phase II
Participants receive the Recommended Phase 2 Dose (RP2D) of ivonescimab and chemotherapy on C1D1, followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with a focus on intracranial progression-free survival.
What Are the Treatments Tested in This Trial?
Interventions
- Ivonescimab
- Stereotactic Radiosurgery
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
In the Phase I portion of the study, patients with NSCLC brain metastases will receive ivonescimab at a starting dose of 10 mg/kg on Day 1 (with chemotherapy), followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10. Following a toxicity check at Day 21, patients will receive standard dosing of ivonescimab with chemotherapy at the discretion of the medical oncologist. In the Phase II portion of the study, patients will receive the RP2D from the initial phase of ivonescimab and chemotherapy on C1D1, followed by stereotactic radiosurgery (9Gy x 3 fractions) starting on Days 7-10.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Summit Therapeutics
Industry Sponsor
Citations
Multiple Ivonescimab Data Sets from Phase III Studies in ...
Three Poster Presentations Will Feature Updated Ivonescimab Data, including Intracranial Anti-Tumor Activity from the Global HARMONi Phase ...
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This randomized clinical trial examines the efficacy of ivonescimab plus chemotherapy vs chemotherapy alone for patients with advanced or metastatic non–small ...
Improved Outcomes Reported With Second-Line Regimen ...
The phase III trial included 438 patients with unresectable locally advanced or metastatic nonsquamous NSCLC with an EGFR mutation and any PD-L1 ...
A randomized phase 3 study of ivonescimab plus ...
The multiregional, randomized, double-blind, phase 3 HARMONi-3 trial (NCT05899608) will compare the efficacy and tolerability of ivonescimab plus chemotherapy ...
A Study of Ivonescimab, Chemotherapy, and Stereotactic ...
The researchers are doing this study to test the safety of ivonescimab given in combination with standard chemotherapy and stereotactic ...
Efficacy and Safety of Ivonescimab in the Treatment of ... - PMC
Ivonescimab showed promising antitumor activity and improved clinical outcomes, particularly in patients with higher PD-L1 expression levels and those ...
Efficacy and safety of ivonescimab in non-small cell lung ...
Ivonescimab (AK112), a novel bispecific antibody targeting PD-1 and VEGF, has emerged as a promising therapeutic agent in the treatment of non-small cell lung ...
Ivonescimab Shows Quality of Life Benefits in ...
According to the EORTC QLQ-LC13 lung cancer-specific questionnaire, patients in the ivonescumab group experienced sustained reductions in scores ...
Ivonescimab: promise or reality for advanced non-small cell ...
Ivonescimab: promise or reality for advanced non-small cell lung cancer? · Table 1. Summary of key efficacy outcomes of phase III trials KEYNOTE- ...
HARMONi Data Update Shows OS HR=0.78, Nominal P= ...
The overallsurvival (OS) hazard ratio (HR) in the HARMONi trial was 0.78, with a nominal p-value of 0.0332. In the North American patients, ...
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