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Chemotherapy + Pembrolizumab +/- Lenvatinib for Lung Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT03004183Trial Design
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Who is running the clinical trial?
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- I am still recovering from major surgery complications.I am currently being treated for an infection.You have a serious autoimmune disease that needed strong medication in the last 2 years.You have had or currently have an irregular heart test (ECG).I have had another type of cancer in the past 3 years.I have received a transplant from another person.My cancer is not primarily treated with EGFR, ALK, or ROS1 therapies.I have provided a sample of my tumor for testing.Your heart's pumping ability is lower than the normal range measured by your local hospital or laboratory.My blood pressure is under control, with or without medication.I have not had major heart problems in the last year.My scans show my tumor is affecting a major blood vessel.I have an immune system disorder or have been on steroids recently.I am not in a clinical trial or haven't been in one for the last 4 weeks.I have had chemotherapy or targeted therapy for my advanced lung cancer.You have a disease that can be measured using a specific medical guideline.I have not had certain medications or radiotherapy recently.If you are a woman, you are pregnant.I have not received a live vaccine in the last 30 days.I have a severe fistula.I have a stomach or intestine condition that affects how I absorb pills.I have untreated brain metastases or cancer in the lining of my brain.My lung cancer is advanced and not squamous cell type.I have been mostly active and able to carry on all pre-disease activities without restriction recently.I have had lung inflammation treated with steroids or currently have lung disease.I have an active case of tuberculosis.I have a history of HIV or Hepatitis B.You are expected to live for at least 3 more months.I have not coughed up blood in the last 2 weeks.My organs are working well.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Group 1: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Placebo
- Group 2: Pemetrexed+Platinum Chemotherapy+Pembrolizumab+Lenvatinib
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
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