Small Cell Lung Cancer (SCLC) Treatments

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Brand Name

Cosela

Generic Name

Trilaciclib

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FDA approval date: February 12, 2021

Classification: Kinase Inhibitor

Form: Injection

What is Cosela (Trilaciclib)?

COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer . COSELA is a kinase inhibitor indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

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Related Clinical Trials

A Prospective, Single-arm Phase II Trial of Trilaciclib Administered Prior to Sacituzumab Tirumotecan in Patients With EGFR-mutated, Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors（PROTECT-2）

Enrollment Status: Recruiting

Publish Date: April 14, 2026

Intervention Type: Drug

Study Phase: Phase 2

Summary: This study is a prospective, single arm phase II clinical trial aimed at patients with advanced non-small cell lung cancer resistant to EGFR-TKI. The aim is to evaluate the efficacy and safety of trilaciclib in bone marrow protection before monotherapy with sacituzumab tirumotecan. Patients with advanced non-small cell lung cancer resistant to EGFR-TKI, after signing informed consent, will be scre...

Study of Trilaciclib and Lurbinectedin in Small Cell Lung Cancer

Enrollment Status: Recruiting

Publish Date: March 30, 2026

Intervention Type: Drug

Study Phase: Phase 2

Summary: Lung cancer is by far the leading cause of cancer death among both men and women worldwide and the second most common cancer in terms of new cases. Small cell lung cancer (SCLC) is the deadliest form of lung cancer. The standard first-line treatment is the combination of carboplatin, etoposide, and atezolizumab. While response rates for this regimen are high (roughly 60%), the duration of response...

Exploration of Indications and Establishment of a Primary Prevention Prediction Model for Trilaciclib in Combination With Chemotherapy in Patients With CDK4/6-Dependent Solid Tumors, and Investigation of the Mechanisms of Related Influencing Factors

Enrollment Status: Recruiting

Publish Date: March 24, 2026

Intervention Type: Drug

Study Phase: Phase 1

Summary: Trilaciclib, an innovative first-in-class therapy that protects bone marrow at the source, has been approved for use in CDK4/6-independent small-cell lung cancer. However, clinical practice shows that patients with solid tumors frequently experience treatment-related pancytopenia involving neutrophils, erythroid lineage, and platelets after antineoplastic therapy, with a particularly high incidenc...

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ToPCourT protocol: a phase II trial of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced/unresectable or metastatic triple-negative breast cancer.

Journal: Future oncology (London, England)

Published: March 11, 2026

NUAK2 is a therapeutically tractable regulator of RNA splicing and tumor progression in neuroendocrine prostate cancer.

Journal: bioRxiv : the preprint server for biology

Published: November 26, 2025

Efficacy and safety of trilaciclib to prevent chemotherapy-induced myelosuppression in advanced solid tumors: a systematic review and meta-analysis.

Journal: Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico

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Brand Information

COSELA (trilaciclib)

1INDICATIONS AND USAGE

2DOSAGE FORMS AND STRENGTHS

For injection: Contains the equivalent of 300 mg of trilaciclib (provided as 349 mg of trilaciclib dihydrochloride) as a sterile, preservative-free, yellow, lyophilized cake in a single-dose vial for reconstitution and further dilution.

3CONTRAINDICATIONS

COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. Reactions have included anaphylaxis

4ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the label:

Injection-Site Reactions, including phlebitis and thrombophlebitis
Acute Drug Hypersensitivity Reactions
ILD/Pneumonitis

4.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of COSELA was evaluated in Studies 1, 2, and 3

5DESCRIPTION

COSELA for injection contains trilaciclib dihydrochloride, a kinase inhibitor.

The chemical name for trilaciclib is 2'-{[5-(4-methylpiperazin-1-yl)pyridin-2-yl]amino}-7',8'-dihydro-6'

Trilaciclib dihydrochloride is a water-soluble yellow solid, with molecular formula of C

COSELA (trilaciclib) for injection is a sterile, preservative-free, yellow lyophilized cake in a single-dose vial for intravenous infusion after reconstitution and dilution.

Each single-dose vial contains the equivalent of 300 mg of trilaciclib (provided as 349 mg of trilaciclib dihydrochloride) and the following inactive ingredients: citric acid monohydrate (75.6 mg) and mannitol (300 mg); hydrochloric acid and sodium hydroxide to adjust pH.

6CLINICAL STUDIES

The efficacy of COSELA was established in three randomized, double-blind, placebo-controlled trials in patients with extensive stage-small cell lung cancer (ES-SCLC). Study 1 (G1T28-05; NCT03041311) enrolled adult patients receiving carboplatin, etoposide, and atezolizumab for newly diagnosed ES-SCLC. Study 2 (G1T28-02; NCT02499770) enrolled adult patients receiving etoposide/carboplatin for newly diagnosed ES-SCLC. Study 3 (G1T28-03; NCT02514447) enrolled adult patients receiving topotecan for previously treated ES-SCLC.

During Cycle 1, all three studies prohibited primary prophylactic granulocyte-colony stimulating factor (G-CSF) and erythropoiesis-stimulating agent (ESA) use. Both ESAs and prophylactic G-CSF were allowed from Cycle 2 onwards as clinically indicated. Therapeutic G-CSF, RBC, and platelet transfusions were allowed at any time during the studies as clinically indicated.