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Alkylating agents
Pembrolizumab + Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Led By Gregory Kalemkerian, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
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 until death or until study stops (up to ~5 years)
Awards & highlights
Study Summary
This trial is testing whether adding the drug pembrolizumab to the standard treatment of carboplatin and pemetrexed will help patients with EGFR-mutation-positive NSCLC who have progressed on targeted therapies.
Who is the study for?
This trial is for adults with NSCLC who have specific genetic changes and whose cancer has grown after targeted therapy. They must be in good physical condition, not have received certain recent treatments, and agree to use contraception. People with other active cancers, untreated brain metastases, or a history of severe immune-related side effects from similar drugs can't join.Check my eligibility
What is being tested?
The study tests if adding pembrolizumab (an immunotherapy drug) to carboplatin and pemetrexed (chemotherapy drugs) helps patients with genetically altered NSCLC who didn't respond to previous targeted therapies. The goal is to see if this combination improves treatment outcomes.See study design
What are the potential side effects?
Pembrolizumab may cause immune system reactions affecting organs, infusion-related symptoms, fatigue; carboplatin/pemetrexed can lead to blood cell count issues, nausea, kidney problems. Side effects vary by individual.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until death or until study stops (up to ~5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death or until study stops (up to ~5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The number of patients that respond to treatment
Secondary outcome measures
Overall survival (OS) time
Progression free survival (PFS) time
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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/Carboplatin/PemetrexedExperimental Treatment3 Interventions
Pembrolizumab 200 mg with carboplatin at AUC (area under the curve dosing) 5 and pemetrexed at 500 mg/m2 administered intravenously every 3 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
FDA approved
Pemetrexed
FDA approved
Pembrolizumab
FDA approved
Find a Location
Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
293 Previous Clinical Trials
24,064 Total Patients Enrolled
Gregory Kalemkerian, M.D.Principal InvestigatorUniversity of Michigan Rogel Cancer Center
3 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to pembrolizumab, carboplatin, pemetrexed, or any of their ingredients.I haven't fully recovered from side effects of my last cancer treatment.I have another cancer that is getting worse or needs treatment soon.I haven't had monoclonal antibody cancer treatment in the last 4 weeks or have recovered from its side effects.I haven't used any experimental drugs or devices in the last 4 weeks.I have taken a pregnancy test within the last week and it was negative.I am willing to use birth control during the study.I have an immune system disorder and am not on high-dose steroids.I have a history of active tuberculosis.I am a man who can father a child and agree to use birth control.I am currently being treated for an infection.I haven't had chemotherapy for advanced NSCLC, except one cycle or as part of earlier treatment over 12 months ago.I have been treated for an autoimmune disease in the last 2 years.I have had or currently have lung inflammation not caused by infection, or I have interstitial lung disease.I have NSCLC with an EGFR mutation and my cancer has grown despite targeted therapy.I have cancer spread to my brain or spinal cord causing symptoms.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have not received a live vaccine in the last 30 days.I have been diagnosed with HIV.I have an active Hepatitis B or C infection.I have mostly recovered from side effects of my previous treatments, except for hair loss.My organs are functioning well.I can carry out all my daily activities without any help.I am 18 years old or older.My lung cancer has a genetic alteration and has grown despite treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab/Carboplatin/Pemetrexed
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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