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Platinum-based Chemotherapy
pembrolizumab for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
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 up to ~51 months
Awards & highlights
Study Summary
This trial is studying pemetrexed + platinum chemotherapy with or without pembrolizumab to treat patients with non-small cell lung cancer that has continued to grow despite treatment with 1-3 prior lines of therapy, including a tyrosine kinase inhibitor (TKI).
Eligible Conditions
- Non-Small Cell Lung Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~51 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~51 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS)
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Secondary outcome measures
Change From Baseline in EORTC-QLQ-C30 Quality of Life (Item 30) Scale Score
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 Item (QLQ-C30) Global Health Status (Item 29) Scale Score
Duration of Response (DOR) Per RECIST 1.1
+4 moreSide effects data
From 2022 Phase 3 trial • 1274 Patients • NCT0222089412%
Weight decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Decreased appetite
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Diarrhoea
9%
Hypothyroidism
9%
Nasopharyngitis
9%
Bronchitis
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Anaemia
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Malaise
3%
Hyperglycaemia
3%
Pneumonia bacterial
3%
White blood cell count decreased
3%
Back pain
3%
Myalgia
3%
Hypertension
3%
Haematemesis
3%
Pyrexia
3%
Hyperthyroidism
3%
Upper respiratory tract infection
3%
Nausea
3%
Dyspnoea
3%
Leukopenia
3%
Chest pain
3%
Rash
3%
Tumour associated fever
3%
Subdural haemorrhage
3%
Lymph gland infection
3%
Upper gastrointestinal haemorrhage
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Pembro+Pemetrexed+ChemoExperimental Treatment4 Interventions
Participants receive pembrolizumab (pembro) 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo) (either carboplatin Area Under the Curve [AUC] 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]).
Group II: Placebo+Pemetrexed+ChemoActive Control4 Interventions
Participants receive normal saline solution via IV infusion on Day 1 of each 3-week cycle (Q3W) for up to 35 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W with no restrictions on the number of cycles PLUS platinum chemotherapy (chemo)(either carboplatin AUC 5 via IV infusion Q3W for 4 cycles [Cycles 1-4] or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles [Cycles 1-4]).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Carboplatin
FDA approved
Pembrolizumab
FDA approved
Pemetrexed
FDA approved
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,079 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,330 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,988 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are expected to live for at least 3 more months.You have fluid buildup in your abdomen or chest that is causing symptoms. If you have received treatment and are feeling better, you can still participate.You have previously been treated with a specific type of medication that affects the immune system's ability to fight cancer.You have untreated cancer that has spread to your brain or the lining of your brain.You are allergic or sensitive to any ingredient in cisplatin, carboplatin, or pemetrexed.You have had a very severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.You have a history of lung inflammation that needed steroids or currently have lung inflammation.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo+Pemetrexed+Chemo
- Group 2: Pembro+Pemetrexed+Chemo
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Do the findings of this pembrolizumab study stand alone, or build on previous research?
"Pembrolizumab is currently being studied in 2045 different trials, 470 of which are Phase 3 clinical trials. The vast majority of these studies are based in Shanghai; however, there are 88863 total locations running pembrolizumab trials."
Answered by AI
Is there a danger in using pembrolizumab for treatment?
"Pembrolizumab is considered safe due to its Phase 3 status and the amount of efficacy and safety data that has been gathered."
Answered by AI
What is the maximum capacity for patients in this program?
"This study is no longer recruiting patients. It was posted on June 29th, 2018 and last edited on August 18th, 2022. However, there are 1995 other trials for lung cancer and 2045 related to pembrolizumab that are still looking for participants."
Answered by AI
What disease does pembrolizumab commonly target?
"Pembrolizumab is an immunotherapy medication indicated for the treatment of patients with unresectable or metastatic melanoma, malignant neoplasms, and microsatellite instability high."
Answered by AI
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