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Checkpoint Inhibitor

Pembrolizumab for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Research Sponsored by Bayer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed diagnosis of stage IV NSCLC.
Phase 1 includes participants meeting either Cohort 1 or Cohort 2 criteria.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat stage IV NSCLC that has spread to the bone. The drugs are Radium-223 dichloride, which is a radioactive agent that kills cancer cells, and pembrolizumab, which is an immunologic checkpoint blocker. The researchers want to measure tumor shrinkage in response to treatment and how long that shrinkage lasts.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Number of participants with adverse events (AEs) in Phase 1
Number of participants with dose limiting toxicities (DLTs) in Phase 1
Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in Phase 2
Secondary outcome measures
DCR per RECIST v1.1 in Phase 2
Disease control rate (DCR) per RECIST v1.1 in Phase 1
DoR per RECIST v1.1 in Phase 2
+5 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%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 Cohort 2: Radium-223+PembrolizumabExperimental Treatment2 Interventions
Participants will receive radium-223 dichloride every 6 weeks in combination with pembrolizumab every 3 weeks
Group II: Phase 2 Cohort 1: Radium-223+PembrolizumabExperimental Treatment2 Interventions
Participants will receive radium-223 dichloride every 6 weeks in combination with pembrolizumab every 3 weeks
Group III: Phase 1: Radium-223+PembrolizumabExperimental Treatment2 Interventions
Participants will receive radium-223 dichloride every 6 weeks in combination with pembrolizumab every 3 weeks
Group IV: Phase 2 Cohort 1: Pembrolizumab aloneActive Control1 Intervention
Participants will receive pembrolizumab every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~1950

Find a Location

Who is running the clinical trial?

BayerLead Sponsor
2,228 Previous Clinical Trials
25,325,155 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,860 Previous Clinical Trials
5,047,847 Total Patients Enrolled

Frequently Asked Questions

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

What is the most typical application of Pembrolizumab?

"Pembrolizumab is frequently employed to treat malignant neoplasms, but it can also be utilized on unresectable melanoma, microsatellite instability high. Furthermore, this drug has been found to help patients in the event of chemotherapy-induced disease progression."

Answered by AI

What prior investigations have included Pembrolizumab in their protocols?

"Currently, Pembrolizumab is being studied in 967 different medical trials with 125 of those studies in their third phase. Most research centres are based out of Houston, Texas but there exists a network of 36090 locations conducting clinical trials for the medication."

Answered by AI

What is the maximum number of enrollees for this experiment?

"Unfortunately, this trial has concluded its recruitment phase. Initially posted on March 6th 2020, it was last updated November 7th 2022. For those searching for other studies related to carcinoma non-small cell lung and Pembrolizumab respectively, 1361 and 967 clinical trials are presently accepting patients."

Answered by AI

Are individuals being enrolled in this experiment at present?

"At the present moment, this clinical trial is not recruiting. Initially posted on March 6th 2020 and most recently updated November 7th 2022, prospective participants should look to other studies for their medical needs. For instance, there are currently 1361 trials admitting patients with carcinoma non-small-cell lung cancer as well as 967 studies actively enrolling those seeking pembrolizumab treatment."

Answered by AI

What adverse effects should patients be aware of when taking Pembrolizumab?

"The safety of pembrolizumab has only been tested to a limited degree, so it received the lowest score on our rating scale of 1."

Answered by AI
~1 spots leftby Mar 2025