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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
Must not have
Has a known additional malignancy that is progressing or requires active treatment within the past 5 years
Has had an allogenic tissue/sold organ transplant
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

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.
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.
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 below
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I am a male and agree to use contraception or abstain and not donate sperm during and after the study.
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My lung cancer is at Stage II, IIIA, or IIIB and has not been treated yet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have another cancer that is getting worse or needed treatment in the last 5 years.
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I have received a transplant from another person.
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I have an active case of tuberculosis.
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My cancer is either in the upper part of my lung, is a large cell neuroendocrine type, or is sarcomatoid.
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I have or had lung inflammation needing steroids.
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I am currently being treated for an infection with medication.
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I have been treated for an autoimmune disease in the last 2 years.
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I have been treated with specific immune therapy for cancer.
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I have had treatment for my current cancer before joining this study.
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I have a history of Hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (cycle 1 in neoadjuvant phase) and end of follow-up (up to approximately 5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event Free Survival (EFS)
Overall Survival (OS)
Secondary study objectives
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 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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

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
Pembrolizumab
2017
Completed Phase 2
~2070
Cisplatin
2013
Completed Phase 3
~2360
Gemcitabine
2017
Completed Phase 3
~1920
Pemetrexed
2014
Completed Phase 3
~5550

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,782 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,174,186 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,078,983 Total Patients Enrolled

Media Library

Cisplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03425643 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: NAC + Neoadjuvant/Adjuvant Placebo, NAC + Neoadjuvant/Adjuvant Pembrolizumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT03425643 — Phase 3
Cisplatin (Platinum-based Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03425643 — Phase 3
~109 spots leftby Sep 2025
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