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CDK4/6 Inhibitor

Abemaciclib for Small Cell Lung Cancer

Phase 2
Recruiting
Led By Afshin Dowlati, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathology confirmed Retinoblastoma wild type tested by NGS or ctDNA.
Performance status: ECOG Performance status ≤ 2.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years from start of study.
Awards & highlights

Study Summary

This trial is testing Abemaciclib as a potential treatment for small cell lung cancer that has not responded to prior treatment or has relapsed.

Who is the study for?
This trial is for adults with certain types of lung cancer that haven't improved after chemotherapy. They should have a specific gene type (Rb wild-type), measurable disease, and be able to take pills orally. Participants need good organ function and can't join if they're pregnant, breastfeeding, or have serious medical conditions like severe lung disease or uncontrolled infections.Check my eligibility
What is being tested?
The study tests Abemaciclib's effectiveness in shrinking tumors in patients with small cell lung cancer and related cancers that are resistant to chemo. It also examines the safety of this drug in those who've had no response to initial treatments or whose cancer returned post-chemo.See study design
What are the potential side effects?
Abemaciclib may cause side effects such as diarrhea, fatigue, low blood counts leading to increased infection risk, liver issues, nausea, hair loss (alopecia), nerve pain (neuropathy), and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is confirmed to be retinoblastoma wild type.
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I can take care of myself but might not be able to do heavy physical work.
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My liver function tests are within the required limits.
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My brain scans show no worsening after treatment for brain metastases.
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My cancer did not respond or returned after platinum-based chemotherapy.
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I have mostly recovered from my last chemotherapy, except for possible hair loss or mild nerve pain.
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My organs are functioning well.
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I can take pills by mouth.
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I finished my radiotherapy at least 14 days ago and have recovered from its immediate effects.
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My cancer is a specific type of lung or related cancer, confirmed by lab tests.
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My blood counts meet the required levels for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years from start of study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years from start of study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
Duration of response in all responders (DoR using RECIST 1.1)
Overall Survival (OS)
Progression Free Survival (PFS) according to RECIST 1.1
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: AbemaciclibExperimental Treatment1 Intervention
Subjects will receive Abemaciclib (200 mg), orally every 12 hours on days 1 to 28 of a 28-day cycle for a total of 56 doses per cycle. Subjects will be evaluated after 4 weeks (1st cycle) and then every 8 weeks (2 cycles) with radiographic imaging to assess response to treatment.

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
447 Previous Clinical Trials
31,325 Total Patients Enrolled
Afshin Dowlati, MDPrincipal InvestigatorCase Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
16 Previous Clinical Trials
696 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04010357 — Phase 2
Neuroendocrine Carcinoma of the Lung Research Study Groups: Abemaciclib
Neuroendocrine Carcinoma of the Lung Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT04010357 — Phase 2
Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04010357 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Jun 2025