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Checkpoint Inhibitor

Pembrolizumab for Preventing Lung Cancer

Phase 2
Recruiting
Led By Jianjun Zhang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female participant must not be pregnant, not breastfeeding, and must follow contraceptive guidance during the treatment period and for at least 120 days for the study treatments with risk of genotoxicity
Patients with no history of lung cancer, who have IPNs detected by low dose CT (LDCT)-guided lung cancer screening or imaging studies for other reasons (incidentalomas) with specific cancer probability by Brock University cancer prediction equation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 6 months
Awards & highlights

Study Summary

This trial is studying how well pembrolizumab works in preventing lung cancer in patients who have either stage I-II non-small cell lung cancer or high-risk pulmonary nodules.

Who is the study for?
This trial is for adults who've had stage I-II non-small cell lung cancer treated curatively, or those with high-risk pulmonary nodules. They must have good blood counts, organ function, and be able to follow the study's contraception rules. Excluded are individuals with active autoimmune diseases, certain infections like hepatitis or tuberculosis, recent use of immunosuppressants or live vaccines, and women who are pregnant or breastfeeding.Check my eligibility
What is being tested?
The IMPRINT-Lung Study is testing pembrolizumab's effectiveness in preventing lung cancer recurrence in patients post-treatment for early-stage disease or those at high risk due to pulmonary nodules. It involves monitoring through CT scans and quality-of-life assessments while receiving this immunotherapy drug that boosts the immune system against cancer cells.See study design
What are the potential side effects?
Pembrolizumab may cause side effects such as fatigue, skin reactions, diarrhea, muscle pain, and can sometimes trigger an immune response affecting organs like lungs (pneumonitis) or liver (hepatitis). Rarely it might lead to severe allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not pregnant or breastfeeding and will follow birth control advice for 120 days due to treatment risks.
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I have lung nodules found by CT scan but no history of lung cancer.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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I had early-stage lung cancer, treated it, and still have small lung nodules.
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I am fully active or can carry out light work.
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I agree to use contraception during and after treatment for the specified times.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Regression rate of high-risk indeterminate pulmonary nodules (IPNs)
Secondary outcome measures
Cancer-free survival
Incidence of adverse events
Incidence of lung cancer
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment4 Interventions
Participants receive pembrolizumab IV over 30 minutes on day 1. Treatment repeat every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans and collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,317 Total Patients Enrolled
Jianjun ZhangPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
50 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03634241 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Pembrolizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT03634241 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03634241 — Phase 2

Frequently Asked Questions

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

How many people are eligible for this clinical study?

"That is correct. The clinicaltrials.gov website says that this research is still looking for patients to enroll. This trial was first posted on November 13th, 2018 and the listing was updated on November 8th, 2022. There are currently 81 participant openings at 2 locations."

Answered by AI

Are researchers looking for new participants in this clinical trial at the moment?

"Yes, this trial is still recruiting patients according to the information available on clinicaltrials.gov. The listing for this study was created on November 13th, 2018 and edited for accuracy on November 8th, 2020."

Answered by AI

What have been the most severe observed side-effects of Pembrolizumab?

"At Power, we rate the safety of Pembrolizumab as a 2. This is because, although there have been Phase 2 trials conducted which support its safety, there is currently no data to suggest that it is an effective treatment."

Answered by AI

What are some of the most popular indications for Pembrolizumab?

"Pembrolizumab is an effective course of treatment for patients with malignant neoplasms, unresectable melanoma, and microsatellite instability high."

Answered by AI

What are the most recent findings on Pembrolizumab?

"City of Hope first began researching pembrolizumab in 2010 and, to date, there have been 375 completed trials. At the moment, there are 1000 active studies being conducted; a significant number of these are based in New york City."

Answered by AI
~3 spots leftby Jul 2024