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New treatment option for Extensive Stage Lung Small Cell Cancer
Official title Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07057791
What this study is testing
What is Ivonescimab 10 mg/kg?
Ivonescimab 10 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive stage lung small cell cancer.
Also referred to as AK112, SMT112.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Eligible untreated participants with Extensive Stage Small Cell Lung Cancer (ES-SCLC) who are ≥ 18 years of age will be randomized to receive ivonescimab 10 milligrams per kilogram (mg/kg) or ivonescimab 20 mg/kg in combination with carboplatin and etoposide. Ivonescimab is a type of drug called a bispecific antibody.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Selection Criteria:
- Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).
- No prior systemic therapy for the disease under study (ES-SCLC).
- Patients must have measurable disease according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
- Patient must be ≥ 18 years of age.
See the full eligibility criteria
Who can join
- Selection Criteria:
- Patients must have pathologically confirmed Extensive Stage Small Cell Lung Cancer (ES-SCLC).
- No prior systemic therapy for the disease under study (ES-SCLC).
- Patients must have measurable disease according to Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
- Patient must be ≥ 18 years of age.
- Patient must have an ECOG performance status of 0-1.
- Patient must have the ability to understand and willingness to sign a written informed consent document.
- Willing to provide archived tumor tissue (if sufficient tumor tissue available) and blood samples for research.
- Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to registration/randomization. No blood transfusions or growth factor therapy allowed within 7 days of screening...
- Absolute Neutrophil Count (ANC) ≥ 1500/microliter (mcL)
- Platelets ˃100,000/mcL
- Hemoglobin \>9.0 gram/deciliter (g/dL)
- Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.5x Upper Limit Normal (ULN), and partial prothrombin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5x ULN
- Serum Creatinine ≤ 2x ULN
- Creatinine clearance (CrCl) ≥ 50 milliliter/minute (mL/min)
- Urine Protein \<2+
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5x ULN or ≤ 5x ULN for patients with liver metastasis
- Total Bilirubin ≤ 1.5x ULN or ≤ 3x ULN for patients with liver metastasis or suspected/documented Gilbert's disease
- Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
- Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for...
- Patients must not have symptomatic central nervous system (CNS) metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or...
- Patients must not have imaging during the screening period that shows:
- Radiologically documented evidence of major blood vessel invasion (central pulmonary artery, central pulmonary veins, aorta, brachiocephalic artery, common carotid artery, subclavian artery, superior vena cava) or tumor...
- Radiographic evidence of major blood vessel encasement with narrowing of the vessel or intratumor lung cavitation or necrosis that the investigator determines will pose a significantly increased risk of bleeding.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- Patients must not have major surgical procedures or serious trauma within 28 days prior to randomization or plans for major surgical procedures within 28 days after the first dose.
- Patients must not have history of bleeding tendencies or coagulopathy and/or clinically significant bleeding symptoms or risk within 4 weeks prior to randomization, including but not limited to:
- Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Transient hemoptysis associated with diagnostic bronchoscopy is allowed.
- Nasal bleeding/epistaxis (bloody nasal discharge is allowed).
- Current use of prophylactic or full-dose anticoagulants or anti-platelet agents for therapeutic purposes that is not stable prior to randomization is not allowed.
- Patients must not have history of major diseases before randomization, specifically:
- Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association (NYHA) classification ≥ Grade 2) or unstable vascular disease (e.g., aortic aneurysm at risk of rupture, Moyamoya disease)...
- History of any grade arterial thromboembolic event, Grade 3 and above venous thromboembolic event, as specified in National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0, transient...
- History of esophageal gastric varices, severe ulcers, wounds that do not heal, abdominal fistula, intra-abdominal abscesses, or acute gastrointestinal bleeding within 6 months prior to randomization.
- History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection...
- Patients must not have poorly controlled hypertension with repeated systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg after oral antihypertensive therapy.
- Patients must not have prolongation of QTc interval \>480 msec
- Patients must not have active autoimmune or lung disease requiring systemic therapy (e.g., with disease modifying drugs, prednisone \>10 mg daily or equivalent, immunosuppressant therapy) within 2 years prior to...
- Patients must not have severe infection within 4 weeks prior to randomization, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic...
- Patients must not have uncontrolled pleural effusions, pericardial effusions, or ascites that is clinically symptomatic.
- Patients must not have history of non-infectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease.
- Patients must not have active or prior history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or chronic diarrhea.
- Patients must not have pre-existing peripheral neuropathy ≥ Grade 2 by CTCAE V5.0.
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of registration/randomization are eligible for this trial.
- Patient must not have received any live vaccine within 28 days prior to registration/randomization.
- Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.
- Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.
- Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
- Baltimore, Maryland, United States
- Morristown, New Jersey, United States
- New Brunswick, New Jersey, United States
- The Bronx, New York, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Sayre, Pennsylvania, United States
- Charlottesville, Virginia, United States
- Wausau, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States; Baltimore, Maryland, United States; Morristown, New Jersey, United States; New Brunswick, New Jersey, United States; The Bronx, New York, United States; Columbus, Ohio, United States and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.