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New hope for Chemo-Resistant lung cancers?

NCT ID NCT04010357

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pill called abemaciclib in 14 people with certain lung cancers (like small cell lung cancer) that stopped responding to chemotherapy. The goal was to see if the drug could shrink tumors and to check its safety. While the drug targets a specific protein to slow cancer growth, it is not a cure and ongoing treatment or monitoring is expected.

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

14 people

The number who actually took part.

Started

Jan 2020

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

19 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.

Inclusion Criteria: * Subjects must have histologically confirmed extensive stage small cell lung cancer, large cell neuroendocrine lung cancer, extrapulmonary small cell cancer or other high grade neuroendocrine cancer of the lung. * Pathology confirmed Retinoblastoma wild type tested by NGS or ctDNA. * Subjects must have: * Platinum refractory disease: defined as no response after 1-2 cycles of chemotherapy, or * Relapse: defined as initial response but relapse after completing platinum-based chemotherapy. * Subjects must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. * Subjects shall have archival tumor material for correlative studies if available. If tissue is not available they still may be eligible for the trial * Performance status: ECOG Performance status ≤ 2 * Patients who received chemotherapy must have recovered CTCAE Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and enrollment (provided the patient did not receive radiotherapy). Please refer to eligibility criteria for specific laboratory requirements. * Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and enrollment. * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression. * The patient is able to swallow oral medications. * The patient has adequate organ function for all of the following criteria, as defined below: * Hematologic system: * absolute neutrophil count (ANC) ≥1.5 × 10\^9/L * Platelets ≥100 × 10\^9/L * Hemoglobin ≥8g/dL (Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion). * Hepatic system: * Total bilirubin ≤1.5 × ULN Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times upper limit of normal (ULN) and direct bilirubin within normal limits are permitted. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN. * The effects of the study medication on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) throughout study participation and for 6 months after completing treatment. * Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior treatment toxicities not resolved to ≤ Grade 1 according to NCI CTCAE Version 5.0 (except alopecia, and neuropathy). * Subjects receiving any other investigational agents. * The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea). * Females who are pregnant or lactating. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Abemaciclib. * Subjects with uncontrolled intercurrent illness including, syncope of cardiac etiology, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, sudden cardiac arrest, or psychiatric illness/social situations that would limit compliance with study requirements. * The patient has active bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment. * HIV-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Abemaciclib. In addition, these subjects are at increased risk of lethal infections when treated with marrow suppressive therapy. Appropriate studies will be undertaken in subjects receiving combination antiretroviral therapy when indicated.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065, United States

More trials for these conditions

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