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Pembrolizumab + Chemotherapy + Radiation for Lung Cancer
Phase 1
Waitlist Available
Led By Salma Jabbour, MD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Serum creatinine OR measured or calculated creatinine clearance (glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance rate [CrCl]) =< 1.5 X upper limit of normal (ULN) OR >= 60 mL/min for subject with creatinine levels > 1.5 X institutional ULN
Must have American Joint Committee on Cancer (AJCC) 7th edition (ed) inoperable stage II disease requiring chemoradiation therapy or stage IIIA or IIIB NSCLC based on appropriate staging studies including brain magnetic resonance imaging (MRI) or head computed tomography (CT), CT chest, and fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT scan
Must not have
Has received a live vaccine within 30 days of planned start of study therapy
Has known active hepatitis B (e.g., hepatitis B virus surface antigen [HBsAg] reactive) or hepatitis C (HCV) (e.g., HCV ribonucleic acid [RNA] [qualitative] is detected)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time of initiation of chemoradiation through study completion (death)
Awards & highlights
Summary
This trial is testing pembrolizumab given with paclitaxel, carboplatin, and radiation therapy to treat stage II-IIIB non-small cell lung cancer to learn the best dose and way to give it, and to find out what side effects it causes.
Who is the study for?
This trial is for adults with stage II-IIIB non-small cell lung cancer who haven't had prior treatments that conflict with the study. They must have good organ function, no active infections or autoimmune diseases, not be pregnant or breastfeeding, and agree to use contraception. People with certain medical conditions or those who've received specific treatments recently are excluded.
What is being tested?
The trial tests pembrolizumab (an antibody therapy) combined with chemotherapy drugs paclitaxel and carboplatin, alongside radiation therapy. It aims to find the safest doses and how well they work together in treating patients by stopping tumor growth and spread.
What are the potential side effects?
Possible side effects include reactions related to the immune system attacking normal cells, infusion-related reactions from the drug entering the body, fatigue, blood disorders like low platelet counts or anemia, liver enzyme changes indicating potential liver damage, kidney function changes, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine or GFR, is within the normal range.
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My lung cancer is at a stage that cannot be surgically removed and requires combined chemotherapy and radiation.
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My lung function test shows I can breathe out at least 1.0 L or 40% of what's expected.
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My lung cancer type was confirmed not just by sputum tests.
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My liver function tests are within the required range.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not received a live vaccine in the last 30 days.
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I have active hepatitis B or C.
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My pleural effusion cannot be managed despite treatments.
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I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.
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I have been diagnosed with HIV.
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I do not have active brain metastases or carcinomatous meningitis.
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I do not have any other ongoing cancers.
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I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.
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I have been treated with drugs targeting PD-1 or PD-L1 before.
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I am currently being treated for an infection.
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I have or had lung inflammation not caused by an infection.
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I have an active TB infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time of initiation of chemoradiation through study completion (death)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time of initiation of chemoradiation through study completion (death)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose (MTD) and Dose Limiting Toxicity (DLT) of the Combination of Pembrolizumab With Paclitaxel, Carboplatin and Radiation Therapy According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Secondary study objectives
Best Overall Response According to Response Evaluation Criteria in Solid Tumors RECIST 1.1
Immune-related Response Evaluation Criteria In Solid Tumors Using Immune-Related Response (irRC).
Metastasis-free Survival as Measured by the Kaplan Meier Estimation Method
+2 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Diarrhea
9%
Anemia
9%
Shortness of Breath
9%
Abdominal pain
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Weight Loss
7%
Dyspnea
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Atrial fibrillation with rapid ventricular response
4%
Pleural effusion
2%
colitis
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (paclitaxel, carboplatin, radiation, pembrolizumab)Experimental Treatment6 Interventions
Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Patients undergo 3D CRT or IMRT QD 5 days a week for 6 weeks. Beginning 2-6 weeks after, 2 weeks before the end, or at the start of chemotherapy and radiation therapy, patients also receive pembrolizumab IV over 30 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Carboplatin
2014
Completed Phase 3
~6120
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Paclitaxel
2011
Completed Phase 4
~5810
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,950 Previous Clinical Trials
5,174,960 Total Patients Enrolled
Rutgers, The State University of New JerseyLead Sponsor
440 Previous Clinical Trials
65,359 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,977 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function, measured by creatinine or GFR, is within the normal range.I agree to use birth control during and for 4 months after the study.I have another cancer, but it's either being treated or not worsening, except for certain skin cancers or cervical cancer.You are allergic to pembrolizumab or any of the ingredients in it.I have not received a live vaccine in the last 30 days.My lung cancer is at a stage that cannot be surgically removed and requires combined chemotherapy and radiation.I am using two birth control methods or am not having sex to join this study.My lung function test shows I can breathe out at least 1.0 L or 40% of what's expected.I have fully recovered from any major surgery before starting treatment.I have active hepatitis B or C.My pleural effusion cannot be managed despite treatments.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I have been diagnosed with HIV.I agree to provide a recent biopsy sample or, if not possible, an older sample with approval.My lung cancer type was confirmed not just by sputum tests.I am fully active or restricted in physically strenuous activity but can do light work.My blood clotting time is normal or managed with medication.I haven't had cancer treatment with a monoclonal antibody in the last 4 weeks or have recovered from its side effects.My blood clotting time is normal or managed if I'm on blood thinners.I do not have active brain metastases or carcinomatous meningitis.I do not have any other ongoing cancers.My liver function tests are within the required range.I haven't had cancer treatment in the last 2 weeks or have recovered from its side effects.My hemoglobin level is above 9 g/dL without needing transfusions or EPO recently.You have had an allergic reaction or sensitivity to any part of the treatment in the past.I have been treated with drugs targeting PD-1 or PD-L1 before.I am currently being treated for an infection.I have or had lung inflammation not caused by an infection.I have an active TB infection.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have mild to moderate nerve damage.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (paclitaxel, carboplatin, radiation, pembrolizumab)
Awards:
This trial has 1 awards, including:- 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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