1600 Participants Needed

Ivonescimab + Pembrolizumab for Lung Cancer

Recruiting at 436 trial locations
SC
Overseen BySummit Clinical Trial Information
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Summit Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatment combinations for people with metastatic non-small cell lung cancer (NSCLC). One group receives ivonescimab (a PD-1/VEGF bi-specific antibody) with chemotherapy, while the other receives pembrolizumab with chemotherapy. The main goal is to determine which combination helps patients live longer and prevents cancer growth. People with Stage IV NSCLC who have not received prior treatment might be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering patients access to potentially groundbreaking treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants should not have received any prior therapy for metastatic non-small cell lung cancer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ivonescimab, when combined with chemotherapy, can be safely administered to patients with advanced non-small cell lung cancer. In earlier studies, patients tolerated it well, and it demonstrated promising tumor-fighting results without major safety concerns.

Pembrolizumab has extensive safety information available due to its approval for several conditions. It is usually well-tolerated, though some patients may experience immune-related side effects, such as skin rashes or mild inflammation. These side effects are generally manageable with standard treatments.

Both treatments in this trial have demonstrated safety for patients, making them promising options for those considering participation.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for lung cancer because they offer unique approaches compared to standard options like chemotherapy and existing immunotherapies. Ivonescimab is an innovative treatment that combines the capabilities of a bispecific antibody targeting two different proteins, potentially enhancing the immune system's ability to attack cancer cells more effectively. Pembrolizumab, already a well-known immunotherapy, is being tested in combination with chemotherapy to assess its efficacy in new settings. These combinations aim to improve patient outcomes by harnessing the power of the immune system in different ways, potentially offering more effective and targeted treatment options.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research shows that ivonescimab, one of the treatments in this trial, has promising results for treating advanced non-small cell lung cancer when combined with chemotherapy. Ivonescimab targets two proteins, PD-1 and VEGF-A, which aid cancer growth. One study found that ivonescimab improved patient outcomes more effectively than pembrolizumab. Pembrolizumab, another treatment option in this trial, is well-known, with studies indicating that about 19-22% of patients live for five years when used with chemotherapy. Both treatments in this trial have shown effectiveness, offering hope for better survival rates in lung cancer patients.13456

Who Is on the Research Team?

IL

Indu Lal

Principal Investigator

Summit Therapeutics, Inc.

Are You a Good Fit for This Trial?

Adults with metastatic squamous non-small cell lung cancer (NSCLC) who have not had previous treatments for their advanced disease. Participants must have a certain level of PD-L1 expression, be in good physical condition (ECOG score 0 or 1), and expect to live at least three more months. They cannot join if they have small cell lung carcinoma, non-squamous NSCLC, major blood vessel involvement by the tumor, or known specific genetic alterations.

Inclusion Criteria

I haven't had any systemic treatment for my advanced lung cancer.
I am fully active or restricted in physically strenuous activity but can do light work.
You are expected to live for at least 3 more months.
See 4 more

Exclusion Criteria

My lung cancer is confirmed to be either small cell or non-squamous non-small cell.
My cancer has specific genetic changes in EGFR, ALK, or ROS1.
I have received treatment for my lung cancer after it spread.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ivonescimab or pembrolizumab combined with chemotherapy for the first-line treatment of metastatic non-small cell lung cancer

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

approximately 6 years

What Are the Treatments Tested in This Trial?

Interventions

  • Ivonescimab
  • Pembrolizumab
Trial Overview This Phase 3 trial is testing Ivonescimab combined with chemotherapy against Pembrolizumab with chemotherapy as first-line treatment options for metastatic squamous NSCLC. The main goal is to see which treatment helps patients live longer without their cancer getting worse.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A - Ivonescimab and chemotherapyExperimental Treatment1 Intervention
Group II: Arm B - Pembrolizumab and chemotherapyActive Control1 Intervention

Ivonescimab is already approved in China for the following indications:

🇨🇳
Approved in China as Ivonescimab for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Summit Therapeutics

Lead Sponsor

Trials
18
Recruited
4,500+

Published Research Related to This Trial

In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]
A 68-year-old patient with stage IV lung adenocarcinoma showed an unexpected positive response to paclitaxel after failing treatment with pembrolizumab, an anti-PD-1 immunotherapy.
The patient experienced a response duration of over fourteen months with paclitaxel, suggesting that combining or sequencing chemotherapy with immunotherapy may enhance treatment effectiveness in certain cases.
[Prolonged response with paclitaxel after immunotherapy by pembrolizumab in lung cancer].Zapata, E., Mennecier, B., Leduc, C., et al.[2017]
Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38642937/
Phase 1a dose escalation study of ivonescimab (AK112/ ...Ivonescimab is a first-in-class, humanized tetravalent bispecific antibody targeting PD-1 and VEGF-A simultaneously.
Phase II results of ivonescimab (AK112/ SMT112), a novel ...Ivonescimab, plus chemotherapy has shown promising anti-tumor activity in pts with advanced/metastatic NSCLC without AGA and can be administered safely.
Akeso, Inc | Ivonescimab Receives NMPA Approval for First ...Ivonescimab has shown superior efficacy over pembrolizumab in the HARMONi-2 Phase III trial, becoming the first therapy to achieve this globally.
AK112, a novel PD-1/VEGF bispecific antibody, in ...This study aimed to evaluate the efficacy and safety of AK112 combined with chemotherapy in patients with advanced non-small cell lung cancer ( ...
A Phase 1b Study of Ivonescimab, a Programmed Cell ...Ivonescimab monotherapy was well tolerated and found to have a promising efficacy in patients with advanced or metastatic NSCLC. ClinicalTrials.
WCLC 2024 | Akeso's Ivonescimab Head-to-Head Phase III ...Ivonescimab as first-line treatment for PD-L1 positive NSCLC significantly extends median progression-free survival (mPFS) compared to pembrolizumab.
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