Ivonescimab for Non-Small Cell Lung Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether ivonescimab, administered after standard radiation therapy (SBRT), effectively treats Non-Small Cell Lung Cancer (NSCLC). The focus is on individuals with early-stage NSCLC who have undergone radiation but not surgery. Ideal participants have tumors treatable with specific types of radiation and have not previously used certain immune therapies. As a Phase 1, Phase 2 trial, it provides an opportunity to be among the first to receive this treatment and help assess its effectiveness.
Do I have to stop taking my current medications for the trial?
The trial requires that you do not use certain medications, like monoclonal antibodies or biologic drugs targeting the immune system, within 4 weeks before starting the study. If you're on systemic immunosuppressive medication, you must stop it 4 weeks prior, with some exceptions like low-dose steroids. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that ivonescimab is likely to be safe for humans?
Research has shown that ivonescimab is usually well-tolerated by people with non-small cell lung cancer (NSCLC). Studies have found that this treatment rarely causes serious side effects. For instance, a review noted that the most common side effects were mild and manageable, with few reports of severe issues like bleeding.
Ivonescimab has also been tested with chemotherapy and demonstrated fewer side effects compared to other treatments. This suggests that ivonescimab could be a safe option for patients, with many able to continue treatment without major problems.
Overall, while more research is ongoing, current evidence indicates that ivonescimab is generally safe for NSCLC patients, with few severe side effects reported.12345Why do researchers think this study treatment might be promising for NSCLC?
Researchers are excited about Ivonescimab for non-small cell lung cancer because it represents a new approach by targeting both the PD-1 and VEGF pathways, potentially enhancing the immune response against cancer cells. Unlike other treatments that commonly focus on only one of these targets, Ivonescimab's dual action could lead to more robust and effective cancer control. Additionally, it is used as a consolidation therapy following standard stereotactic body radiotherapy (SBRT), which might help in maintaining the treatment's effectiveness and preventing cancer recurrence.
What evidence suggests that ivonescimab might be an effective treatment for Non-Small Cell Lung Cancer?
Studies have shown that ivonescimab can effectively treat non-small cell lung cancer (NSCLC). Research indicates that ivonescimab helps patients live longer without their cancer worsening, a benefit known as improved progression-free survival (PFS). Specifically, ivonescimab has demonstrated better results than pembrolizumab, a common treatment, in patients with higher levels of a protein called PD-L1. Evidence also suggests that ivonescimab can help patients live longer overall, referred to as improved overall survival (OS). In this trial, participants will receive ivonescimab as a consolidation treatment after undergoing Photon or Proton standard stereotactic body radiotherapy (SBRT). These findings are promising for using ivonescimab to manage NSCLC.24678
Who Is on the Research Team?
Narek Shaverdian, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for people with early-stage non-small cell lung cancer (NSCLC) whose tumors are suitable for a specific type of focused radiation (SBRT). Participants can't have certain genetic mutations, prior immune therapy, or tumors touching the esophagus. Surgery must not be an option for them.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation
Participants receive standard stereotactic body radiotherapy (SBRT) as part of usual care
Treatment
Participants receive ivonescimab during 21-day treatment cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ivonescimab
- Photon or Proton standard stereotactic body radiotherapy (SBRT)
Trial Overview
The study tests if giving ivonescimab after standard stereotactic body radiotherapy (SBRT) helps treat NSCLC. All participants get SBRT first and then receive ivonescimab to see if this combination works better than SBRT alone.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patient will receive SBRT as part of usual care. About 4 to 6 weeks after SBRT, patient will receive ivonescimab during 21-day treatment Cycles.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
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- ...
Efficacy and safety of ivonescimab in non-small cell lung ...
Since the OS data of most studies are not yet mature, therefore, outcomes of interest included PFS, ORR, disease control rate (DCR), and the incidence of AEs.
Ivonescimab Shows Quality of Life Benefits in ...
Based on the HARMONi-2 results, ivonescimab became the first therapy to show a significant PFS benefit over pembrolizumab in a head-to-head ...
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 ...
Ivonescimab versus pembrolizumab in PD-L1-positive ...
The efficacy results from the HARMONi-2 trial show a ... Ivonescimab versus pembrolizumab for PD-L1-positive non-small cell lung cancer ...
Efficacy and Safety of Ivonescimab in the Treatment of ... - PMC
This systematic review critically evaluates the safety and efficacy of the novel drug Ivonescimab in the treatment of advanced and metastatic ...
Efficacy and safety of ivonescimab in non-small cell lung ...
Efficacy and safety of ivonescimab in non-small cell lung cancer: a systematic review and meta-analysis of emerging clinical data · Abstract.
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oncologynewscentral.com
oncologynewscentral.com/nsclc/bispecific-may-be-new-standard-of-care-for-certain-nsclc-phase-3-data-suggestBispecific May Be New Standard of Care for Certain ...
“Ivonescimab plus chemotherapy is the first to demonstrate a clinically ORR and PFS across the PD-1 subgroup, with a low rate of hemorrhage even ...
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