36 Participants NeededMy employer runs this trial

Ivonescimab for Non-Small Cell Lung Cancer

Recruiting at 6 trial locations
NS
CS
Overseen ByCharles Simone, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

NS

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

I have been diagnosed with non-small cell lung cancer.
My lung cancer is early stage and meets the size and spread limits for this study.
I have two separate lung cancers confirmed by pathology and genetic tests.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive standard stereotactic body radiotherapy (SBRT) as part of usual care

4-6 weeks

Treatment

Participants receive ivonescimab during 21-day treatment cycles

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

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

Group I: Ivonescimab Consolidation after Photon or Proton SBRTExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

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 ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41710928/

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.

Bispecific 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 ...