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Chemotherapy

Pembrolizumab for Small Cell Lung Cancer

Phase 2

Recruiting

Led By Wade Iams, MD

Research Sponsored by Vanderbilt-Ingram Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of small cell lung cancer or high grade neuroendocrine carcinoma will be enrolled in this study

Creatinine or measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine Clearance [CrCl]) =< 1.5 X upper limit of normal (ULN) or >= 30 mL/min for participant with creatinine levels > 1.5 X institutional ULN (specimens must be collected within 10 days prior to the start of study intervention)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial studies an immunotherapy to help fight limited stage small cell lung cancer after standard treatment.

Who is the study for?

Adults with small cell lung cancer who have completed chemoradiation or surgery followed by chemotherapy can join this trial. They must have a stable immune system, no active infections, and not be pregnant or breastfeeding. Participants should not have other cancers needing treatment, severe allergies to pembrolizumab, or recent vaccinations.Check my eligibility

What is being tested?

The trial is testing if the drug pembrolizumab improves outcomes when given after standard treatments for limited stage small cell lung cancer. Pembrolizumab is an immunotherapy that may help the body fight cancer more effectively.See study design

What are the potential side effects?

Pembrolizumab can cause side effects like fatigue, skin reactions, inflammation in organs such as lungs (pneumonitis), liver problems, hormonal gland issues (like thyroid dysfunction), and it might worsen autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with a confirmed diagnosis of small cell lung cancer or high-grade neuroendocrine carcinoma.

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My kidney function tests are within the required range.

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My liver function tests are within normal limits.

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My scans show no cancer growth after my last major cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival

Secondary outcome measures

Incidence of adverse events

Overall survival

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (pembrolizumab)Experimental Treatment9 Interventions

Patients undergo radiation therapy and receive cisplatin or carboplatin on day 1 of each cycle and etoposide on days 1-3 for 4 cycles. Patients then receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan during screening. Patients also undergo MRI throughout the trial as well as CT. Additionally, patients undergo blood sample collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Radiation Therapy

2017

Completed Phase 3

~7250

Cisplatin

2013

Completed Phase 3

~1940

Carboplatin

2014

Completed Phase 3

~6670

Etoposide

2010

Completed Phase 3

~2440

Pembrolizumab

2017

Completed Phase 2

~2010

Computed Tomography

2017

Completed Phase 2

~2720

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,126 Total Patients Enrolled

Vanderbilt-Ingram Cancer CenterLead Sponsor

213 Previous Clinical Trials

60,913 Total Patients Enrolled

Wade Iams, MDPrincipal InvestigatorVanderbilt University/Ingram Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available opportunities to participate in this clinical trial?

"According to clinicaltrials.gov, this particular research study is no longer open for enrollment as its last edit was on the 10th of November 2023 and it had been initially announced on the 31st December in the same year. Despite not accepting new patients anymore, there are 1622 other trials currently looking for participants."

Answered by AI

Has pembrolizumab attained clearance from the FDA?

"Although data for the efficacy of pembrolizumab has yet to be collected, there is some evidence supporting its safety and thus it was given a rating of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab After Radiation Therapy and Chemotherapy in Limited Stage Small Cell Lung Cancer

Wade Iams 2024. "Pembrolizumab After Radiation Therapy and Chemotherapy in Limited Stage Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06140407.

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