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

What Was Tested

The trial (phase 3) is built around Romiplostim.

It had two arms (groups): Romiplostim (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

This is a phase 3, randomized, placebo-controlled, multicenter, international study for the treatment of CIT in adult subjects receiving chemotherapy for the treatment of NSCLC, ovarian cancer, or breast cancer.

Subjects must have a platelet count ≤ 85 x 10\^9/L on day 1 of the study.

The study will consist of a screening period of up to 4 weeks, a treatment period long enough to allow for assessment of 3 planned cycles of chemotherapy, a follow-up visit, and long-term follow-up (LTFU).

Who Took Part

The registry lists 145 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males or females greater than or equal to 18 years of age at signing of the informed consent. Subjects must have a local platelet count ≤ 85 x 109/L on day 1 of the study. 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.

The full record lists 8 inclusion and 36 exclusion criteria; among the exclusions: acute lymphoblastic leukemia; acute myeloid leukemia; any myeloid malignancy.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Romiplostim group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Romiplostim, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-02-26 with completion listed for 2026-03-10.

It ran at 34 sites in Turkey (Türkiye) (10), Greece (5), Spain (4), Brazil (3), Romania (3) and United States (2).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 11 secondary outcomes, for example Depth of Platelet Count, Time to First platelet response, the duration-adjusted event rate of ≥ grade 2 bleeding events, Overall survival, Proportion of subjects with at leat 1 incidence of platelet transfusion and proportion of patients achieving platelet count >= 100 x 10 9/L.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 145 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.