← Back to Search

Platinum-based Chemotherapy

Chemotherapy + Pembrolizumab +/- Lenvatinib for 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
Confirmation that EGFR, ALK, or ROS1-directed therapy is not indicated as primary treatment
Provided an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 47 months
Awards & highlights

Study Summary

This trial is testing a new combination of drugs to treat lung cancer. The hypothesis is that the new combination will prolong survival compared to the standard treatment.

Who is the study for?
Adults with Stage IV nonsquamous non-small cell lung cancer who haven't had previous metastatic NSCLC treatment can join. They must have a life expectancy of at least 3 months, good performance status, controlled blood pressure, no major organ dysfunction and agree to use contraception. Exclusions include recent vaccines, other cancers within 3 years, active infections like TB or HIV, certain heart conditions and those with severe allergies to monoclonal antibodies.Check my eligibility
What is being tested?
The trial is testing the effectiveness of pemetrexed + platinum chemotherapy + pembrolizumab with or without lenvatinib in treating this type of lung cancer. It aims to see if adding lenvatinib improves survival without disease progression and overall lifespan compared to the standard treatment without it.See study design
What are the potential side effects?
Possible side effects include high blood pressure from lenvatinib; immune reactions from pembrolizumab such as fatigue, skin issues or inflammation; plus typical chemo effects like nausea, hair loss and increased infection risk due to lowered white blood cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is not primarily treated with EGFR, ALK, or ROS1 therapies.
Select...
I have provided a sample of my tumor for testing.
Select...
My blood pressure is under control, with or without medication.
Select...
My lung cancer is advanced and not squamous cell type.
Select...
I have been mostly active and able to carry on all pre-disease activities without restriction recently.
Select...
My organs are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 47 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 47 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Study Intervention Discontinuations Due to Adverse Events
Part 1: Number of Participants with One or More Adverse Events
Part 1: Number of Participants with a Dose-limiting Toxicity
+2 more
Secondary outcome measures
Part 2: Change from Baseline in Global Health Status/Quality of Life (QoL); Cough; Chest Pain; Dyspnea; and Physical Functioning
Part 2: Number of Participants Who Discontinue Study Treatment Due to an Adverse Event
Part 2: Number of Participants with One or More Adverse Events
+4 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Kidney Injury and/or Infection
7%
Pneumonia
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Activated partial thromboplastin time prolonged
5%
Intractable pain, back pain, hip pain
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Skin rash
2%
Thrombocytopenia
2%
Respiratory failure
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+LenvatinibExperimental Treatment5 Interventions
Participants receive carboplatin Area Under Curve 5 mg/mL/min (AUC5) or cisplatin 75 mg/m^2 via intravenous (IV) infusion on Day 1 of each 3-week cycle (Q3W) for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS lenvatinib via oral capsule once daily for up to 2 years.
Group II: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+PlaceboPlacebo Group5 Interventions
In Parts 1 and 2: Participants receive carboplatin AUC5 or cisplatin 75 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pemetrexed 500 mg/m^2 via IV infusion Q3W for 4 cycles PLUS pembrolizumab via IV infusion Q3W for up to 35 cycles (up to 2 years) PLUS (Part 2 only) placebo matching lenvatinib via oral capsule once daily for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lenvatinib
FDA approved
Carboplatin
FDA approved
Pembrolizumab
FDA approved
Cisplatin
FDA approved
Pemetrexed
FDA approved

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,048,939 Total Patients Enrolled
Eisai Inc.Industry Sponsor
515 Previous Clinical Trials
153,338 Total Patients Enrolled
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,150 Total Patients Enrolled

Media Library

Carboplatin (Platinum-based Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03829319 — Phase 3
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03829319 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo, Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Pembrolizumab been a focus of other medical research in the past?

"There are 2121 ongoing studies involving Pembrolizumab with 482 of those in the critical third phase. Although the majority of these trials originate from Shanghai, China, there are 90204 locations worldwide where patients can receive this treatment."

Answered by AI

What are we hoping to achieve by the end of this trial?

"The primary outcome that will be measured over the course of this trial is progression-free survival (PFS), as assessed by a blinded independent central review (BICR) according to RECIST 1.1, modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. In addition, this trial will also measure secondary outcomes including the number of participants who discontinue study treatment due to an adverse event, time to true deterioration as assessed by change from baseline in global health status/quality of life, cough, chest pain, dyspnea, and physical functioning, and objective response rate (OR"

Answered by AI

What diseases or conditions does Pembrolizumab usually help manage?

"Pembrolizumab is an immunotherapy treatment that can be used to fight cancerous growths, including unresectable melanoma and microsatellite instability high neoplasms."

Answered by AI

Have there been any official reviews of pembrolizumab by the FDA?

"Pembrolizumab has been studied in multiple Phase 3 trials, meaning there is evidence of its efficacy and it has undergone extensive safety testing. We rate it a 3 on our Power scale."

Answered by AI

How many different locations are overseeing this clinical trial?

"Right now, this trial is taking place in 26 different locations. They are situated in Hamilton, Corvallis and Philadelphia as well as other cities. If you enroll in the study, try to choose a location near you to limit travel."

Answered by AI

Does this research project have any room for new participants?

"This study is not currently recruiting patients. The trial was first posted on 3/25/2019 and last updated on 8/22/2022. If you are looking for other studies, there are presently 1951 studies actively searching for participants with malignant neoplasms and 2121 trials for Pembrolizumab actively recruiting participants."

Answered by AI
~127 spots leftby Mar 2025