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Platinum-based Chemotherapy
Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm during the treatment period and for the time needed to eliminate each study intervention after the last dose of study intervention
Have previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years)
Awards & highlights
Study Summary
This trial will see if a new cancer treatment is better than current treatments. The new treatment is pembrolizumab (MK-3475) given before and after surgery for people with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC).
Who is the study for?
This trial is for adults with untreated, resectable Stage II-III NSCLC. Participants must have good organ function and performance status (ECOG 0-1), agree to contraception guidelines, and provide a tumor tissue sample. Exclusions include HIV, prior cancer treatments for the current malignancy, certain lung cancer types, severe allergies to study drugs or their components, active autoimmune diseases requiring treatment in the past 2 years, other health conditions that could affect participation or trial results.Check my eligibility
What is being tested?
The trial tests pembrolizumab combined with platinum doublet chemotherapy before surgery (neoadjuvant phase) and pembrolizumab alone after surgery (adjuvant phase). It aims to improve event-free survival and overall survival compared to placebo. Patients are randomly assigned to receive either pembrolizumab or placebo alongside standard chemotherapy before and after surgical removal of the lung tumor.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues like thyroid disorders; also possible are infusion reactions during drug administration. Chemotherapy can lead to nausea/vomiting, hair loss, fatigue and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a male and agree to use contraception or abstain and not donate sperm during and after the study.
Select...
My lung cancer is at Stage II, IIIA, or IIIB and has not been treated yet.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event Free Survival (EFS)
Overall Survival (OS)
Secondary outcome measures
Adverse Events (AEs)
Global Health Status/Quality of Life (GHS/QoL) Score using the European Organization for Research and Treatment (EORTC) QoL Questionnaire (QLQ-C30)
Major Pathological Response (mPR) Rate
+3 moreSide 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: NAC + Neoadjuvant/Adjuvant PembrolizumabExperimental Treatment4 Interventions
Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, intravenous (IV); given on cycle day 1] in combination with platinum doublet neoadjuvant chemotherapy (NAC), consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1].
Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of pembrolizumab [200 mg, IV; given on cycle day 1].
Group II: NAC + Neoadjuvant/Adjuvant PlaceboPlacebo Group4 Interventions
Neoadjuvant: Prior to surgery, participants receive up to 4 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1] in combination with platinum doublet NAC, consisting of cisplatin [75 mg/m^2, IV; given on cycle day 1] and either Gemcitabine [1000 mg/m^2, IV; given on cycle days 1 and 8] or Pemetrexed [500 mg/m^2, IV; given on cycle day 1].
Adjuvant: 4-12 weeks following surgery, participants receive 13 cycles (cycle length: 3 weeks) of placebo [normal saline, IV; given on cycle day 1].
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pemetrexed
2014
Completed Phase 3
~5250
Pembrolizumab
2017
Completed Phase 2
~2010
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,025 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,774 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,683 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer that is getting worse or needed treatment in the last 5 years.I have received a transplant from another person.I have an active case of tuberculosis.I am a male and agree to use contraception or abstain and not donate sperm during and after the study.My cancer is either in the upper part of my lung, is a large cell neuroendocrine type, or is sarcomatoid.I am currently being treated for an infection with medication.I have or had lung inflammation needing steroids.I have been treated for an autoimmune disease in the last 2 years.I have been treated with specific immune therapy for cancer.I have had treatment for my current cancer before joining this study.I have not received a live vaccine in the last 30 days.I have an immune system disorder or have been on steroids or other immune-weakening drugs in the last week.My lung cancer is at Stage II, IIIA, or IIIB and has not been treated yet.I am not pregnant or breastfeeding, and if I can have children, I agree to use birth control during and after the study.I had radiotherapy less than 2 weeks before starting the trial.My organs are functioning well.You have a severe allergic reaction (Grade 3 or higher) to any of the chemotherapy drugs being used in the study.I can provide a tissue sample or slides for PD-L1 testing.You have been diagnosed with HIV.You have a severe allergic reaction to pembrolizumab or any of its ingredients.I am fully active or restricted in physically strenuous activity but can do light work.I have a history of Hepatitis B or C.
Research Study Groups:
This trial has the following groups:- Group 1: NAC + Neoadjuvant/Adjuvant Placebo
- Group 2: NAC + Neoadjuvant/Adjuvant Pembrolizumab
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is Pembrolizumab commonly given as a treatment for other conditions?
"Pembrolizumab is the standard course of treatment for refractory, relapsed mediastinal large b-cell lymphoma. In addition, Pembrolizumab has shown to be effective in treating other cancers like urinary bladder, advanced testicular cancer, and small cell lung cancer (sclc)."
Answered by AI
Could you please tell us if Pembrolizumab has been used in other research trials?
"Pembrolizumab is being studied in 443 Phase 3 trials out of a total of 1960 ongoing investigations. The global distribution of these trials is significant, with 79276 centres running pembrolizumab studies. However, the largest concentration of these trials is in Shanghai, China."
Answered by AI
In how many places can patients volunteer for this research?
"prospective patients can consult the full list of 33 clinical trial sites, but a few notable locations include McGill University Health Centre (Site 0111) in Montreal, Quebec, Memorial Sloan Kettering Cancer Center - Nassau (Site 0078) in Uniondale, New york, and OHSU Center for Health & Healing (Site 1006) in Portland, Oregon."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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