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Pembrolizumab for Non-Small Cell Lung Cancer

Phase 2
Waitlist Available
Research Sponsored by Greg Durm, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of treatment start until death or up to a maximum of 40 months
Awards & highlights

Study Summary

This trial will study whether continuing treatment with the immunotherapy drug pembrolizumab is effective for people who have responded to treatment with another immunotherapy drug.

Eligible Conditions
  • Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of treatment start until death or up to a maximum of 40 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and time of treatment start until death or up to a maximum of 40 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
Progression Free Survival (PFS)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Number of Participants With Adverse Events
Objective Response Rate (ORR)
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab 200mg IV every 21 daysExperimental Treatment1 Intervention
Patients who have been treated with a PD-1 or PD-L1 inhibitor and experienced a PFS of ≥3 months will be enrolled within 6 weeks of last dose of PD-1 or PD-L1 inhibitor. On Day 1 of each 3-week cycle, subjects will first receive pembrolizumab at a dose of 200mg IV every three weeks in combination with chemotherapy. Partner chemotherapy will be either gemcitabine 1000mg/m^2 IV D1 and D8 every three weeks, docetaxel 75mg/m^2 IV D1 every three weeks, or pemetrexed 500mg/m^2 IV D1 every 3 weeks (pemetrexed for non-squamous histologies only). Subjects will continue to receive this combination until progression or intolerable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Greg Durm, MDLead Sponsor
3 Previous Clinical Trials
356 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,536 Total Patients Enrolled
Big Ten Cancer Research ConsortiumOTHER
10 Previous Clinical Trials
439 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals are enrolled in this research program?

"Unfortunately, this research is no longer actively recruiting patients. Initially posted on March 20th 2017 and last edited June 24th 2022, the trial has concluded its recruitment phase. Other trials for carcinoma non-small cell lung cancer have been made public with a total of 2045 studies currently accepting participants while 961 clinical trials are looking to recruit people that would be given Pembrolizumab as part of the study."

Answered by AI

Has the Food and Drug Administration given their stamp of approval to Pembrolizumab?

"There is some clinical evidence to suggest the safety of Pembrolizumab, so it received a rating of 2 on our scale. However, there are no studies that have conclusively proven its efficacy yet."

Answered by AI

Is recruitment for this experiment still taking place?

"Per the data hosted on clinicaltrials.gov, this medical trial is no longer enrolling participants as it was last edited on June 24th 2022. Although not actively recruiting anymore, there are still 3006 other trials that are seeking patients at the current time."

Answered by AI

How many geographical areas is the experiment being conducted in?

"Five clinical sites are accepting patients for this trial, including the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis, University of Iowa Hospital Clinics in Iowa City and the University of Wisconsin in Madison. There are two other locations as well."

Answered by AI

What medical condition is Pembrolizumab typically employed to treat?

"Pembrolizumab is a potential treatment for cancerous tumours, unresectable melanoma lesions, and microsatellite instability high diseases."

Answered by AI

Have any other experiments been conducted using Pembrolizumab?

"Pembrolizumab was initially investigated in 2010 at the City of Hope, since then 251 studies have concluded. Currently 961 trials are underway with multiple locations based around Indianapolis, Indiana."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase II Trial of Continuation Therapy in Advanced NSCLC
Greg Durm, MD 2017. "Phase II Trial of Continuation Therapy in Advanced NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03083808.
~4 spots leftby Apr 2025
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