RecruitingPhase 2

Phase II Study of Platinum/Etoposide Plus Ivonescimab for Extensive-Stage Small Cell Lung Cancer

Phase II Dose Optimization Study of Platinum/Etoposide Plus Ivonescimab (CEI) as First-Line Treatment of Extensive-Stage Small Cell Lung Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Research blood samples will also be obtained for future research which may include measuring the level of ivonescimab in the blood and immune responses or antibodies to ivonescimab."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two doses of ivonescimab with the chemotherapy drugs carboplatin and etoposide. It is for adults with small cell lung cancer that has spread widely and has not been treated with medicines that work throughout the body. Researchers will compare how well the doses work and check side effects.

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. Antibodies are proteins that specifically recognize and bind to other types of proteins called antigens. Antibodies and antigens can work together to help the immune system fight cancer cells. Bispecific antibody, meaning it targets two different molecules at the same time. Ivonescimab is a new drug that may help the immune system attack cancer cells and may also block certain pathways that cancer uses to grow and spread. This dual action of ivonescimab aims to help the immune system to fight the cancer and also disrupt tumor growth by blocking blood vessel formation that tumors use to grow. Participants will receive induction with 4 cycles of ivonescimab (dose determined by randomization) with standard of care carboplatin and etoposide followed by maintenance therapy with ivonescimab at the same dose received during induction. Treatment will continue until disease progression, unacceptable toxicity or participant withdrawal. The purpose of this study is to determine what dose of ivonescimab works best in combination with carboplatin and etoposide chemotherapy in ES-SCLC. We will also examine the side effects, good and bad, associated with ivonescimab.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have small cell lung cancer confirmed by a tissue test that has spread widely.
  • Have had no prior treatment for this cancer with medicines that work throughout the body.
  • Have tumors that can be measured on scans.
  • Be fully active or able to do light work despite some limits on hard physical activity.
  • Be able to understand the study and sign a consent form.
  • Agree to give blood samples and stored tumor tissue, if enough tissue is available.
  • Have blood tests showing that your organs and bone marrow work well enough. No blood transfusions or medicines to boost blood cell counts are allowed within 7 days before screening tests.

Who can't join

  • Being pregnant or breastfeeding, or not agreeing to prevent pregnancy through birth control or no sex during the study and for 120 days after the last dose.
  • Cancer in the brain or spinal cord that causes symptoms, is at least 1.5 cm, was treated with radiation in the past 7 days, or may need radiation in the first treatment cycle; or cancer in the lining around the brain or spinal cord.
  • Tumor growth into certain major blood vessels or organs, or scan findings that raise the risk of serious bleeding or abnormal openings between organs.
  • Major surgery or serious injury within 28 days before study assignment, planned major surgery within 28 days after the first dose, or certain bleeding problems or unstable use of blood-thinning medicines.
  • Certain serious heart, blood vessel, blood clot, stroke, stomach, or bowel problems; poorly controlled blood pressure; or a certain abnormal heart rhythm test result.
  • Certain immune system or lung diseases, recent serious or active infections, uncontrolled fluid buildup causing symptoms, inflammatory bowel disease, chronic diarrhea, or moderate or worse nerve damage.
  • A live vaccine within the past 28 days, an allergy to study drugs or their ingredients, or a serious medical or mental health condition that could prevent completing treatment.
  • Joining another treatment study during this study without prior approval.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 labs. * 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 120 days after the last dose of study drug(s). * 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 leptomeningeal disease. * Patients must not have imaging during the screening period that shows: 1. 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 invading organs (heart, trachea, esophagus, central bronchi \[not including segmental bronchi\]) or if there is a risk of esophagotracheal or esophagopleural fistula . 2. 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 efficacy assessment of the investigational regimen are eligible for this trial. * 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: 1. Hemoptysis (defined as coughing up ≥ 0.5 teaspoon of fresh blood or small blood clots). Transient hemoptysis associated with diagnostic bronchoscopy is allowed. 2. Nasal bleeding/epistaxis (bloody nasal discharge is allowed). 3. 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: 1. 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) that required hospitalization within 12 months prior to randomization, or other cardiac impairment that may affect the safety evaluation of the study drug (e.g., poorly controlled arrhythmias, myocardial ischemia). 2. 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 ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy within 12 months prior to randomization. 3. 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. 4. History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection) within 6 months prior to randomization. * 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 randomization. * 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 anti-infective therapy within 2 weeks prior to randomization (excluding antiviral therapy for hepatitis B or C). * 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.

Study sites (13)

FL

IL

MD

NJ

NY

OH

PA

VA

WI