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Could a bone marrow shield improve chemo for aggressive lung cancer?

NCT ID NCT03041311

Disease control Sponsor: G1 Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding a drug called trilaciclib to standard chemotherapy could protect the bone marrow and immune system in people with advanced small cell lung cancer. About 100 participants received either trilaciclib or a placebo alongside their chemo. The main goal was to see if it reduced severe low white blood cell counts and shortened the time patients were at risk for infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

107 people

The number who actually took part.

Started

Jun 2017

Finished

Oct 2020

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Male or female subjects aged ≥18 years * Unequivocally confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry * Extensive-stage SCLC * At least 1 target lesion that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 * Predicted life expectancy of ≥3 months * Able to understand and sign an informed consent Exclusion Criteria: * Limited-stage SCLC * Prior chemotherapy for limited or extensive-stage SCLC * Prior treatment with immunotherapies including but not limited to cluster of differentiation 137 agonists or immune checkpoint blockade therapies (such as anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1(PD-L1), and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) therapeutic antibodies). * Presence of symptomatic brain metastases requiring immediate treatment with radiation therapy or steroids. * Malignancies other than SCLC within 3 years prior to randomization, with the exception of those with negligible risk of metastasis or death treated with expected curative outcome * History of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan * Active, known, suspected autoimmune disease requiring systemic treatment in the past 2 years * Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure * Known history of stroke or cerebrovascular accident within 6 months prior to enrollment * Serious active infection at the time of enrollment * Psychiatric illness/social situations that would limit study compliance * Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol * Known human immunodeficiency virus, known active hepatitis B, or hepatitis C * Radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment * Receipt of any investigational medication within 4 weeks prior to enrollment * Administration of attenuated vaccine within 4 weeks before enrollment or anticipation that such a live attenuated vaccine will be required during the study * Influenza vaccination should be given during influenza season only (approx. Oct to March). Patients must not receive live, attenuated influenza vaccine (eg, FluMist) within 4 weeks prior to enrollment at any time during the study, and at least 5 months after the last dose of atezolizumab. * Patients with a condition requiring systemic treatment with either corticosteroids ( \> 10 mg daily prednisone equivalents) or other immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days of study drug administration. Inhaled or topical steroids ad adrenal replacement dosed \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Hypersensitivity to any of the components of the formulation of etoposide or etoposide phosphate * Hypersensitivity to carboplatin or other platinum-containing compounds or to mannitol * History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies * Legal incapacity or limited legal capacity * Pregnant or lactating women

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Conditions

The condition(s) this trial relates to.

small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Small cell lung cancer

Contacts and locations

Locations

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Blue Ridge Cancer Care

    Blacksburg, Virginia, 24060, United States

  • CHU Caen De La Côte De Nacre

    Caen, 14033, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Chernivtsi Regional Clinical Oncology Center

    Chernivtsi, 58013, Ukraine

  • Complex Oncology Center - Burgas

    Burgas, 8000, Bulgaria

  • Daugavpils Regional Hospital, Department of Oncology

    Daugavpils, LV-5417, Latvia

  • Dnipropetrovsk City Multispecialty Clinical Hospital #4

    Dnipro, 49102, Ukraine

  • East Tallinn Central Hospital Ltd., Clinic of Internal Medicine, Center for Oncology

    Tallinn, 11312, Estonia

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060, United States

  • Gibbs Cancer Center

    Spartanburg, South Carolina, 29303, United States

  • H. Donostia, Hospital Donostia- Servicio de Oncología

    San Sebastián, 20014, Spain

  • H.U. Quirón Dexeus, Hospital Universitario

    Barcelona, 08028, Spain

  • Horizon Oncology Center

    Lafayette, Indiana, 47905, United States

  • Hospital 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Arnau de Vilanova

    Valencia, 46015, Spain

  • Hospital Clinic de Barcelona- Servicio de Oncología Médica

    Barcelona, 08036, Spain

  • Hospital Clínico

    San Carlos, Madrid, 28040, Spain

  • Hospital Teresa Herrera

    A Coruña, La Coruña, 15006, Spain

  • Hospital Universitario Ntra. Sra. de Valme

    Seville, 41014, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Son Espases

    Palma, Balearic Islands, 07120, Spain

  • Joliet Oncology-Hematology Associates

    Joliet, Illinois, 60435, United States

  • Loma Linda University

    Loma Linda, California, 92350, United States

  • Lviv State Regional Treatment and Diagnostics Oncology Center

    Lviv, 79031, Ukraine

  • Millennium Oncology

    Houston, Texas, 77090, United States

  • Multiprofile Hospital for Active Treatment "Serdika"

    Sofia, 1303, Bulgaria

  • Multiprofile Hospital for Active Treatment "Serdika", Sofia

    Sofia, 1303, Bulgaria

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549, United States

  • Northside Hospital - Georgia Cancer Specialists

    Atlanta, Georgia, 30341, United States

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121, United States

  • Oklahoma University - Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117, United States

  • Pauls Stradiņš Clinical University Hospital, Oncology Clinic

    Riga, LV-1002, Latvia

  • Piedmont Cancer Institute

    Atlanta, Georgia, 30318, United States

  • Redwood Regional Medical Group (RRMG) - Fountain Grove

    Santa Rosa, California, 95403, United States

  • Singing River Health System

    Whittier, California, 90603, United States

  • St. Jude Heritage Healthcare

    Fullerton, California, 92835, United States

  • St. Louis Cancer Care, LLP, North County

    Bridgeton, Missouri, 63044, United States

  • Summit Medical Group, P.A.

    Morristown, New Jersey, 07962, United States

  • The Alvin J. Siteman Cancer Center - Center for Advanced Med

    St Louis, Missouri, 63110-1094, United States

  • Trinity Health - Trinity CancerCare Center

    Minot, North Dakota, 58701, United States

  • UCLA Medical Center - Santa Monica Hematology And Oncology

    Santa Monica, California, 90404, United States

  • Valley Cancer Associates

    Harlingen, Texas, 78550, United States

  • Virginia Cancer Specialists

    Arlington, Virginia, 22031, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.