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Monoclonal Antibodies

Ivonescimab + Pembrolizumab for Lung Cancer

Phase 3
Recruiting
Research Sponsored by Summit Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No prior systemic treatment for metastatic NSCLC
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Study Summary

This trial compares the effects of two treatments for metastatic lung cancer on overall survival, progression free survival, response, and safety.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site, immune-related issues such as inflammation in various organs due to an overactive immune response, fatigue, and complications related to chemotherapy like nausea and low blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I haven't had any systemic treatment for my advanced lung cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lung cancer has spread to other parts of my body.
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My lung cancer is confirmed to be squamous type.
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My tumor shows a certain level of PD-L1 expression.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Secondary outcome measures
Adverse Event (AE)
Progression-Free Survival (PFS)

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A - Ivonescimab and chemotherapyExperimental Treatment1 Intervention
Subject will receive ivonescimab and chemotherapy
Group II: Arm B - Pembrolizumab and chemotherapyActive Control1 Intervention
Subject will receive pembrolizumab and chemotherapy

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Who is running the clinical trial?

Summit TherapeuticsLead Sponsor
10 Previous Clinical Trials
2,249 Total Patients Enrolled
~267 spots leftby Sep 2027
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