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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
Must not have
Histologic or cytopathologic evidence of the presence of small cell lung carcinoma, or non-squamous NSCLC histology
Known actionable genomic alterations in epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS1 or genes for which first-line approved therapies are available
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 4 years
Awards & highlights

Summary

This trial is testing two treatments for advanced lung cancer. One uses a new drug, Ivonescimab, and the other uses an existing drug, Pembrolizumab, both combined with chemotherapy. The goal is to see which treatment helps patients live longer and has fewer side effects.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lung cancer is confirmed to be either small cell or non-squamous non-small cell.
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My cancer has specific genetic changes in EGFR, ALK, or ROS1.
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I have received treatment for my lung cancer after it spread.
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My cancer has spread to major blood vessels or caused holes in the tumor.

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

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

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468
40%
FATIGUE
37%
INFUSION RELATED REACTION
37%
NAUSEA
23%
DIARRHEA
23%
BACK PAIN
23%
ABDOMINAL PAIN
23%
ANOREXIA
20%
ARTHRALGIA
20%
COUGH
20%
NON-CARDIAC CHEST PAIN
17%
DYSPNEA
17%
CONSTIPATION
17%
CHILLS
17%
MYALGIA
13%
DIZZINESS
13%
HEADACHE
13%
PRURITUS
13%
RASH MACULO-PAPULAR
10%
ANEMIA
10%
URTICARIA
10%
SINUS TACHYCARDIA
10%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY
10%
EDEMA LIMBS
10%
ALLERGIC REACTION
10%
ANXIETY
10%
LUNG INFECTION
10%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY
7%
TUMOR PAIN
7%
EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY
7%
HYPERGLYCEMIA
7%
PAIN
7%
PELVIC PAIN
7%
PRODUCTIVE COUGH
7%
PLEURAL EFFUSION
7%
VOICE ALTERATION
7%
VOMITING
7%
FEVER
7%
FLATULENCE
7%
CREATININE INCREASED
7%
HYPERTHYROIDISM
7%
NECK PAIN
7%
DEPRESSION
7%
FLU LIKE SYMPTOMS
7%
LYMPHOCYTE COUNT DECREASED
7%
DYSPEPSIA
7%
FLUSHING
7%
HYPONATREMIA
7%
HYPOTHYROIDISM
7%
URINARY TRACT INFECTION
3%
MUSCLE WEAKNESS LOWER LIMB
3%
ALKALINE PHOSPHATASE INCREASED
3%
DYSPHAGIA
3%
ESOPHAGITIS
3%
GASTROESOPHAGEAL REFLUX DISEASE
3%
OSTEONECROSIS OF JAW
3%
BRONCHOSPASM
3%
PNEUMONITIS
3%
SORE THROAT
3%
BLURRED VISION
3%
GAIT DISTURBANCE
3%
HEMORRHOIDS
3%
POSTNASAL DRIP
3%
PRESYNCOPE
3%
ACUTE KIDNEY INJURY
3%
PERIPHERAL MOTOR NEUROPATHY
3%
DRY SKIN
3%
FLASHING LIGHTS
3%
HYPOMAGNESEMIA
3%
HYPERTENSION
3%
HYPOTENSION
3%
SINUSITIS
3%
SYNCOPE
3%
HEARING IMPAIRED
3%
RASH ACNEIFORM
3%
SOMNOLENCE
3%
COLITIS
3%
HOT FLASHES
3%
RESPIRATORY FAILURE
3%
CONJUNCTIVITIS
3%
MOVEMENTS INVOLUNTARY
3%
NASAL CONGESTION
3%
PARESTHESIA
3%
VAGINAL INFECTION
3%
GASTROINTESTINAL DISORDERS - OTHER, SPECIFY
3%
NEUTROPHIL COUNT DECREASED
3%
ALLERGIC RHINITIS
3%
PAIN IN EXTREMITY
3%
SEPSIS
3%
BLOATING
3%
DEHYDRATION
3%
DRY MOUTH
3%
INSOMNIA
3%
MALAISE
3%
PAIN OF SKIN
3%
THROMBOEMBOLIC EVENT
3%
TREMOR
3%
WEIGHT GAIN
100%
80%
60%
40%
20%
0%
Study treatment Arm
Imprime PGG 4 mg/kg
Imprime PGG 2 mg/kg

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

Find a Location

Who is running the clinical trial?

Summit TherapeuticsLead Sponsor
12 Previous Clinical Trials
2,197 Total Patients Enrolled
~267 spots leftby Sep 2027
Unbiased ResultsWe believe in providing patients with all the options.
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