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 Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre Trial Comparing Efficacy and Safety of Trilaciclib Versus Placebo in Participants With Limited-stage Small Cell Lung Cancer

Enrollment Status: Recruiting

Publish Date: June 17, 2026

Intervention Type: Drug

Study Phase: Phase 3

Summary: The goal of this clinical trial is to compare the efficacy and safety of trilaciclib versus placebo in subjects with limited stage small cell lung cancer. The main question it aims to answer is: Does trilaciclib have a myeloprotective effect in subject with limited stage small cell lung cancer? Participants will be randomised to receive either trilaciclib or placebo.

I-SPY Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2)

Who is this study for: Patients with Breast Cancer

Enrollment Status: Recruiting

Publish Date: May 06, 2026

Intervention Type: Drug

Study Drugs: Standard Therapy, AMG 386 +/- Trastuzumab, AMG 479 (Ganitumab)+Metformin, MK-2206 +/- Trastuzumab, AMG 386+Trastuzumab, T-DM1+Pertuzumab, Pertuzumab+Trastuzumab, Ganetespib, ABT-888, Neratinib, PLX3397, Pembrolizumab - 4 Cycle, Talazoparib+Irinotecan, Patritumab+Trastuzumab, Pembrolizumab - 8 Cycle, SGN-LIV1A, Durvalumab+Olaparib, SD-101+Pembrolizumab, Tucatinib+Trastuzumab and Pertuzumab, Cemiplimab, Cemiplimab+REGN3767, Trilaciclib +/- Trastuzumab+Pertuzumab, SYD985 ([vic-]Trastuzumab Duocarmazine), Oral Paclitaxel+Encequidar+Dostarlimab (TSR-042)+Carboplatin +/- Trastuzumab, Oral Paclitaxel+Encequidar+Dostarlimab (TSR-042) +/- Trastuzumab

Study Phase: Phase 2

Summary: The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic resonance imaging (MRI) images along with tissue and blood samples) are predictors of treatment success.

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...

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Related Latest Advances

A decade of progress in small-cell lung cancer (2015-2025): a narrative review.

Journal: European journal of clinical pharmacology

Published: April 21, 2026

Cyclotherapy: exploiting cell-cycle decoupling for selective cancer cytotoxicity and normal-tissue protection.

Journal: Cancer treatment reviews

Published: March 13, 2026

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)

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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.