Skip to content
Clinical Trials – home

Trilaciclib Dihydrochloride Dihydrate: A Promising Treatment for Extensive Stage Small Cell Lung Cancer

0 / 1
trials open to patients / all trials
9+
Countries

In short

This article explores the use of Trilaciclib Dihydrochloride Dihydrate in clinical trials for patients with Extensive Stage Small Cell Lung Cancer (ES-SCLC). The drug is being studied in combination with topotecan chemotherapy to assess its potential benefits in improving overall survival and reducing chemotherapy-induced side effects. The trial aims to evaluate the drug's effectiveness, safety, and impact on various aspects of patient care during cancer treatment.

At a glance

Study Type
Randomized, Double-Blind, Placebo-Controlled
Primary Objective
Evaluate non-inferiority of trilaciclib vs placebo in overall survival
Patient Population
Adults with Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Treatment
Trilaciclib or placebo administered before topotecan chemotherapy
Key Endpoints
Overall survival, progression-free survival, objective response rate, myelosuppression-related outcomes
Safety Assessments
Adverse events, laboratory abnormalities, treatment discontinuations
Dosing
Maximum daily dose: 240 mg/m², Maximum total dose: 1200 mg/m²
Treatment Duration
Up to 120 days

What is Trilaciclib?

Trilaciclib Dihydrochloride Dihydrate, also known by its product code G1T28-1, is a medication being studied for the treatment of Extensive Stage Small Cell Lung Cancer (ES-SCLC). It is administered through an intravenous infusion, which means it is given directly into a vein.

Medical Condition: Extensive Stage Small Cell Lung Cancer

Extensive Stage Small Cell Lung Cancer (ES-SCLC) is an advanced form of lung cancer that has spread beyond the lungs to other parts of the body. This type of cancer is known for its aggressive nature and often requires intensive treatment.

How Trilaciclib Works

Trilaciclib is designed to be given before chemotherapy treatment. Its main purpose is to help protect the bone marrow and immune system from the harmful effects of chemotherapy. By doing this, it aims to reduce some of the side effects associated with cancer treatment, such as:

  • Neutropenia: A decrease in white blood cells, which can increase the risk of infections
  • Anemia: A decrease in red blood cells, which can cause fatigue and weakness
  • Thrombocytopenia: A decrease in platelets, which can lead to easy bruising and bleeding

Clinical Trial Details

A clinical trial is currently being conducted to evaluate the effectiveness of Trilaciclib in patients with ES-SCLC. Here are some key points about the study:

  • It is a randomized, double-blind, placebo-controlled study. This means that participants are randomly assigned to receive either Trilaciclib or a placebo, and neither the patients nor the doctors know which one they're receiving during the study.
  • The study aims to determine if Trilaciclib can improve overall survival in patients receiving a chemotherapy drug called topotecan.
  • The researchers will also look at other factors such as how long the cancer stays under control (progression-free survival) and how well patients respond to the treatment (objective response rate).

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria. Some of the key requirements include:

  • Having a confirmed diagnosis of ES-SCLC
  • Having cancer that has progressed during or after previous chemotherapy
  • Being in overall good health, with adequate organ function
  • Not having received previous treatment with topotecan or Trilaciclib

There are also several conditions that would exclude a patient from participating, such as having certain other medical conditions or having received specific treatments recently.

Potential Benefits of Trilaciclib

The researchers hope that Trilaciclib will provide several benefits to patients with ES-SCLC:

  • Improved overall survival
  • Reduced side effects from chemotherapy, particularly those affecting blood cells
  • Fewer hospitalizations due to chemotherapy-induced side effects
  • Potentially allowing patients to receive their full planned chemotherapy doses without delays or reductions

Safety Considerations

As with any medical treatment, safety is a crucial concern. The clinical trial will closely monitor patients for any side effects or adverse events. Some specific safety measures include:

  • Regular monitoring of blood cell counts
  • Watching for signs of infection or fever
  • Monitoring for any allergic reactions to the medication
  • Checking for any effects on heart function

It's important to note that while Trilaciclib shows promise, it is still being studied, and more research is needed to fully understand its effects and potential benefits for patients with ES-SCLC.

Questions people often ask

Conditions where Trilaciclib Dihydrochloride Dihydrate is being studied

Each condition opens its own overview and trial list

Trials with Trilaciclib Dihydrochloride Dihydrate

Recruiting trials first

See all 1 →
Quick filters
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).