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Could a bone marrow shield make chemotherapy safer for lung cancer patients?

NCT ID NCT02514447

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a drug called trilaciclib in 123 people with advanced small cell lung cancer who were getting chemotherapy. The goal was to see if trilaciclib could protect the bone marrow and immune system from chemotherapy damage, reducing severe side effects like low white blood cell counts. The study had two parts: an initial open-label dose-finding phase and a larger randomized double-blind phase.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

123 people

The number who actually took part.

Started

Oct 2015

Finished

Oct 2021

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 * Confirmed diagnosis of SCLC by histology or cytology, preferably including the presence of neuroendocrine features by immunohistochemistry * Progression during or after prior first- or second-line chemotherapy and eligible to receive topotecan therapy * At least 1 target lesion that is measurable by RECIST, Version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 * Adequate organ function Key Exclusion Criteria: * Presence of brain metastases requiring immediate treatment with radiation therapy or steroids. * Uncontrolled ischemic heart disease or uncontrolled symptomatic congestive heart failure * Known history of stroke or cerebrovascular accident within 6 months prior to enrollment * Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could affect compliance or follow-up in the protocol * Concurrent radiotherapy to any site or radiotherapy within 2 weeks prior to enrollment or previous radiotherapy to the target lesion sites * Receipt of any systemic chemotherapy regimen within 4 weeks prior to enrollment or a noncytotoxic investigational medication within 2 weeks prior to enrollment * History of topotecan treatment for SCLC

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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

  • AZ Klina

    Brasschaat, 2930, Belgium

  • AnMed Health

    Anderson, South Carolina, 29621, United States

  • Clinic for Pulmology, Clinical Centre of Serbia

    Belgrade, 11000, Serbia

  • Clinical Center Nis, Clinic for Lung Diseases

    Niš, 18204, Serbia

  • Clinical Hospital Centre Bezanijska Kosa

    Belgrade, 11000, Serbia

  • Clinical Hospital Centre Osijek

    Osijek, 31000, Croatia

  • Compassionate Cancer Care Medical Group, Inc.

    Corona, California, 92879, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Florida Cancer Specialists - North

    Tavares, Florida, 32778, United States

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 33916, United States

  • Gabrail Cancer Center

    Canton, Ohio, 44718, United States

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913, United States

  • Gibbs Cancer Center

    Spartanburg, South Carolina, 29303, United States

  • Greenville Health System

    Greenville, South Carolina, 29605, United States

  • Guthrie Medical Group, PC

    Sayre, Pennsylvania, 18840, United States

  • Hanna Cancer Associates - University of Tennessee

    Knoxville, Tennessee, 37920, United States

  • Highlands Oncology Group

    Rogers, Arkansas, 72758, United States

  • Institute for Pulmonary Diseases of Vojvodina Clinic for Thoracic Oncology

    Kamenitz, 21204, Serbia

  • M.D. Anderson

    Houston, Texas, 77030, United States

  • Meharry Medical College

    Nashville, Tennessee, 37208, United States

  • Memorial Hospital - University of Colorado Health

    Colorado Springs, Colorado, 80909, United States

  • Millennium Oncology

    Houston, Texas, 77090, United States

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756, United States

  • North Shore Hematology Oncology Associates PC

    East Setauket, New York, 11733, United States

  • Northside Hospital - Georgia Cancer Specialists

    Atlanta, Georgia, 30341, United States

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98684, United States

  • Oklahoma University - Peggy and Charles Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73117, United States

  • Oncology and Radiology Institute of Serbia

    Belgrade, 11000, Serbia

  • POKO POPRAD, s.r.o.

    Poprad, 05801, Slovakia

  • Regional Medical Oncology Center

    Wilson, North Carolina, 27893, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Saint Luke's Cancer Institute

    Kansas City, Missouri, 64111, United States

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37232, United States

  • Southwest Cancer Center

    Lubbock, Texas, 79415, United States

  • Sutter Medical Group

    Sacramento, California, 95816, United States

  • Texas Oncology

    Tyler, Texas, 75702, United States

  • Texas Oncology- Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • The Oncology Institute of Hope and Innovation

    Whittier, California, 90603, United States

  • The University of Texas Health Science Center at Tyler

    Tyler, Texas, 75708, United States

  • University Cancer and Blood Center, LLC

    Athens, Georgia, 30607, United States

  • University Clinic of Radiotherapy and Oncology Skopje

    Skopje, 1000, North Macedonia

  • University Clinic of Respiratory and Allergic Diseases Golnik

    Golnik, Slovenia

  • University Clinical Centre Banja Luka

    Banja Luka, 78000, Bosnia and Herzegovina

  • University Clinical Centre Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • University Clinical Hospital Centre " Sestre Milosrdnice"

    Zagreb, 10000, Croatia

  • University Hospital Centre Zagreb, Clinic For Pulmonary Diseases Jordanovac

    Zagreb, 10000, Croatia

  • University of Colorado Health, Oncology Clinical Research Northern Region

    Fort Collins, Colorado, 80528, United States

  • VOU Department of Radiotherapy and Oncology

    Košice, 04191, Slovakia

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

More trials for these conditions

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