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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
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
The number of patients that respond to treatment
Secondary study objectives
Overall survival (OS) time
Progression free survival (PFS) time
Side effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
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
300 Previous Clinical Trials
24,332 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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
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.
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