Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Non-small Cell Lung Cancer (NSCLC), Ovarian Cancer, or Breast Cancer

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Chemotherapy-induced Thrombocytopenia

In brief

To evaluate the efficacy of romiplostim for the treatment of CIT in patients receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer measured by the ability to administer on-time, full-dose chemotherapy

Key facts

Study ID

NCT03937154

Run by

Amgen

People needed

145

Starts

2020-02-26

Expected to finish

2027-02-23

Last updated by the study team

2026-04-07

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject has provided informed consent prior to initiation of any study-specific activities/procedures or subject's legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
• Males or females greater than or equal to 18 years of age at signing of the informed consent.
• Documented active stage I, II, III or IV locally advanced or metastatic of the following tumor types: NSCLC, breast cancer, or ovarian cancer (includes fallopian tube epithelial carcinomas and peritoneal epithelial carcinoma of unknown primary), or any stage recurrent disease. Patients with documented locally advanced (stage III) NSCLC should not be amenable to definitive treatment with chemoradiation and/or surgery.
• Subjects must be receiving cancer treatment with 21- or 28-day cycles, using one of the following carboplatinum-based combination chemotherapy regimens: carboplatin/gemcitabine based, carboplatin/pemetrexed based, carboplatin/liposomal doxorubicin based or carboplatin/taxane based (which includes either paclitaxel, nab-paclitaxel, or docetaxel) or single agent chemotherapy regimen with any of the above mentioned drugs. Use of combination regimens with one of the above carboplatinum-based regimens is permitted with (1) anti-angiogenic agents (such as bevacizumab); (2) targeted therapy (such as anti-epidermal growth factor agents or anti- human epidermal growth factor receptor 2) or (3) immune checkpoint inhibitors. Cycle duration is based on intervals between day 1 of chemotherapy cycles (overlapping with carboplatin intervals) every 21 or 28 day cycles for single agent regimens. OR, Subjects must have CIT from a non-protocol chemotherapy regimen, planning to start treatment with one of the above protocol chemotherapy regimens which has been delayed ≥ 1 week due to CIT.
• Subjects must have a local platelet count ≤ 85 x 109/L on day 1 of the study.
• Subjects must be at least 21 or 28 days removed from the start of the chemotherapy cycle immediately prior to study day 1 if receiving a 21-day or 28-day cycle chemotherapy regimen, respectively.
• Subjects must have at least 3 remaining planned cycles of chemotherapy at study enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

You may not qualify if…

• Acute lymphoblastic leukemia.
• Acute myeloid leukemia.
• Any myeloid malignancy.
• Myelodysplastic syndrome. Baseline bone marrow biopsy is not required to rule out MDS. However, if a bone marrow biopsy and cytogenetics were performed as part of diagnostic or staging work-up, these results will be collected to confirm.
• Myeloproliferative disease.
• Multiple myeloma.
• Within 4 months prior to enrollment, any history of active congestive heart failure (New York Heart Association [NYHA] Class III to IV), symptomatic ischemia, uncontrolled arrhythmias, clinically significant electrocardiogram (ECG) abnormalities, screening ECG with corrected QT (QTc) interval of greater than 470 msec, pericardial disease, or myocardial infarction.
• Major surgery less than or equal to 28 days or minor surgery less than or equal to 3 days prior to enrollment.
• New or uncontrolled venous thromboembolism or thrombotic events within 3 months prior to screening. To be eligible, subjects must have received at least 14 days of anticoagulation for a new thrombotic event and considered to be stable and suitable for continued therapeutic anticoagulation during trial participation.
• History of arterial thrombotic events (eg, myocardial ischemia, transient ischemic attack, or stroke) within 6 months prior to screening.
• Evidence of active infection within 2 weeks prior to the first dose of study treatment.
• Known human immunodeficiency virus infection with any detectable viral load at screening. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results.
• Known active of chronic hepatitis C or hepatitis B infection. Subjects without a documented diagnosis in their medical history will require a local laboratory assessment at screening. If local laboratory results are not available use central laboratory results. Hepatitis B and C infection is based on the following results:
• Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
• Negative HBsAg and positive for hepatitis B core antibody: hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
• Positive hepatitis C virus antibody: hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
• In addition to the conditions listed in exclusion criteria 201 through 206, secondary malignancy within the past 5 years except:
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
• Adequately treated cervical carcinoma in situ without evidence of disease.
• Adequately treated breast ductal carcinoma in situ without evidence of disease.
• Prostatic intraepithelial neoplasia without evidence of prostate cancer.
• Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
• Malignancy treated with curative intent and with no known active disease present for greater than or equal to 3 years before enrollment and felt to be at low risk for recurrence by the treating physician (excluding malignancies listed in exclusion criteria 201 - 206).
• Thrombocytopenia due to another etiology other than CIT (eg, chronic liver disease, prior history of immune thrombocytopenia purpura).
• Any combined modality regimen containing radiation therapy or surgery occurring concomitantly with neo-adjuvant chemotherapy or where radiation therapy is planned during the cycle preceding 3 planned on-study cycles of chemotherapy.

Where it is running

• Los Angeles Cancer Network — Anaheim, California, United States
• University of California Irvine — Orange, California, United States
• Colorado West Healthcare System dba Grand Valley Oncology — Grand Junction, Colorado, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Ocala Oncology Center — Ocala, Florida, United States
• Mid Florida Hematology and Oncology Centers PA — Orange City, Florida, United States
• Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• University of Chicago — Chicago, Illinois, United States
• Orchard Healthcare Research Inc — Skokie, Illinois, United States
• Christus Saint Frances Cabrini Hospital — Alexandria, Louisiana, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Christus Highland Cancer Treatment Center — Shreveport, Louisiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• American Oncology Partners, PA — Bethesda, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Hattiesburg Clinic Hematology/Oncology — Hattiesburg, Mississippi, United States
• Oncology Hematology Associates — Springfield, Missouri, United States
• Great Falls Clinic — Great Falls, Montana, United States
• Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Regional Cancer Care Associates — Sparta, New Jersey, United States
• Broome Oncology LLC — Binghamton, New York, United States
• Saint Lukes University Health Network — Bethlehem, Pennsylvania, United States
• The Center for Cancer and Blood Disorders — Fort Worth, Texas, United States
• Community Cancer Trials of Utah — Ogden, Utah, United States
• Saint Bernards Medical Center — Jonesboro, Arkansas, United States

Full record on ClinicalTrials.gov

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