Pharmacosmos initiates phase III clinical trial of trilaciclib in limited-stage small cell lung cancer
Holbaek, 17 March 2026
Pharmacosmos initiates phase III clinical trial of trilaciclib in limited-stage small cell lung cancer
Pharmacosmos today announced the initiation of a phase III, randomised, double-blind, placebo-controlled, multicentre clinical trial evaluating the efficacy and safety of trilaciclib in participants with limited-stage small cell lung cancer. The study is being conducted at clinical sites in the United States, EU and the United Kingdom.
The trial will compare trilaciclib with placebo when administered prior to standard chemoradiotherapy and is designed to assess whether trilaciclib can reduce chemotherapy-induced myelosuppression and improve treatment tolerability in patients with limited-stage small cell lung cancer.
Trilaciclib is currently approved and marketed in the United States for use prior to platinum/etoposide-containing or topotecan-containing regimens in adults with extensive-stage small cell lung cancer, where it is indicated to decrease the incidence of chemotherapy-induced myelosuppression.
Limited-stage small cell lung cancer represents an earlier stage of the disease, in which the cancer is confined to one side of the chest and treatment is typically delivered with curative intent using concurrent chemotherapy and radiation (chemoradiotherapy). As with extensive-stage disease, treatment of limited-stage disease is associated with chemotherapy-induced myelosuppression, which can lead to dose reductions, treatment delays and an increased risk of complications.
Chemotherapy-induced myelosuppression is traditionally managed once it occurs. The study evaluates a novel approach in which bone marrow protection is administered prior to chemotherapy. Trilaciclib is a short-acting CDK4/6 inhibitor administered intravenously prior to chemotherapy. By transiently inducing cell-cycle arrest in haematopoietic stem and progenitor cells, trilaciclib is designed to protect all blood cell lineages from chemotherapy-induced damage.
“With this phase III study, we are extending the clinical development of trilaciclib into limited-stage small cell lung cancer,” said Lars Lykke Thomsen, Executive Vice President and Chief Medical Officer at Pharmacosmos. “We look forward to evaluating the role of bone marrow protection with trilaciclib in patients with limited-stage small cell lung cancer receiving intensive chemoradiotherapy.”
Pharmacosmos has submitted regulatory applications for trilaciclib in extensive-stage small cell lung cancer outside the United States.
About the study
The phase III study is a randomised, double-blind, placebo-controlled, multicentre trial conducted in the United States, EU and the United Kingdom evaluating trilaciclib administered prior to standard chemoradiotherapy in participants with limited-stage small cell lung cancer. The study will assess efficacy and safety endpoints related to chemotherapy-induced myelosuppression and overall treatment tolerability.
About trilaciclib
Trilaciclib is an intravenous CDK4/6 inhibitor designed to be administered prior to chemotherapy to protect bone marrow function. It is approved in the United States for use in adults receiving a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.
About Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 700 specialists across the UK, Ireland, the Nordics, Germany, Canada, the USA, and China
Contact
Christian Lundquist Madsen,
Vice President Global Marketing & Communication
+45 5948 5959 clm@pharmacosmos.com