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Alkylating agents
Pembrolizumab + Chemotherapy for Non-Small Cell Lung Cancer
Phase 2
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No planned radiation or other cancer treatment in the 3 months following registration
Histologic or cytologic diagnosis of non-small cell lung cancer (adenocarcinoma). Stage IV or recurrent metastatic non-small cell lung cancer. No planned initiation of definitive (potentially curative) concurrent chemo-radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing pembrolizumab with or without chemotherapy to treat patients with stage IV non-small cell lung cancer that has come back and spread to other places in the body.
Who is the study for?
This trial is for patients aged 70 or older with advanced non-small cell lung cancer that has returned and spread. Participants must have proper organ function, no untreated brain metastases, be off corticosteroids, speak English to complete questionnaires, and not plan other cancer treatments within 3 months of joining.Check my eligibility
What is being tested?
The study tests pembrolizumab (an immunotherapy drug) alone or combined with chemotherapy drugs pemetrexed and carboplatin in elderly patients. It aims to see if these treatments can shrink tumors by helping the immune system attack the cancer or by stopping tumor growth.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects like inflammation in organs, fatigue, skin reactions, and changes in hormone levels. Chemotherapy can lead to nausea, hair loss, low blood cell counts increasing infection risk, tiredness, and possible kidney issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no cancer treatments planned for the next 3 months.
Select...
My lung cancer is advanced or has returned, and I'm not planning on undergoing a treatment aimed at curing it.
Select...
I do not have an autoimmune disorder, haven't had an organ transplant, and am not on immunosuppressants.
Select...
I don't have untreated brain cancer and am not on steroids.
Select...
I am starting pembrolizumab treatment soon, as recommended by my doctor.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of grade 3 or worse adverse events post registration
Secondary outcome measures
Comprehensive geriatric assessment risk score
Overall survival (OS)
Quality of life (QOL): Linear Analogue Self-Assessment [LASA] questionnaire
Trial Design
2Treatment groups
Experimental Treatment
Group I: Group B (pembrolizumab, pemetrexed, carboplatin)Experimental Treatment6 Interventions
Patients receive pembrolizumab IV over 30 minutes, pemetrexed IV over 10 minutes, and carboplatin IV per institutional guidelines on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Group A (pembrolizumab)Experimental Treatment4 Interventions
Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Pemetrexed
2014
Completed Phase 3
~5250
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,566 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,537 Total Patients Enrolled
Aminah Jatoi, MDStudy ChairMayo Clinic
28 Previous Clinical Trials
2,636 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin level in the blood is within a certain range, unless you have Gilbert's disease, in which case it can be slightly higher.I have no cancer treatments planned for the next 3 months.Your platelet count is at least 100,000 per cubic millimeter.My lung cancer is advanced or has returned, and I'm not planning on undergoing a treatment aimed at curing it.I do not have an autoimmune disorder, haven't had an organ transplant, and am not on immunosuppressants.I am receiving a specific treatment combination for my condition.My kidney function meets the required levels for the treatment I am considering.Your liver enzymes (AST and ALT) are not more than 3 times the normal limit, or not more than 5 times the normal limit if you have cancer that has spread to the liver.I don't have untreated brain cancer and am not on steroids.Your absolute neutrophil count is at least 1500 per cubic millimeter.I finished my previous cancer treatment over 6 months ago.I am starting pembrolizumab treatment soon, as recommended by my doctor.Your alkaline phosphatase levels are not too high, unless you have bone or liver metastases, in which case they can be a little higher.
Research Study Groups:
This trial has the following groups:- Group 1: Group B (pembrolizumab, pemetrexed, carboplatin)
- Group 2: Group A (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Lung Cancer Patient Testimony for trial: Trial Name: NCT04533451 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research endeavor still open to potential volunteers?
"As indicated on clinicaltrials.gov, this medical project is actively recruiting patients. It was first made available to the public on October 1st 2020 and its details were most recently updated April 18th 2022."
Answered by AI
Have any previous investigations explored Quality-of-Life Assessment?
"Quality-of-Life Assessment first emerged as a research subject in 2002 at Bristol Royal Hospital for Children. Since its inception, 1496 studies have been conducted and concluded with 1596 trials still ongoing today. A significant number of these are being operated out of Mullica Hill, New jersey."
Answered by AI
What is the breadth of geographic sites partaking in this analysis?
"Subjects are being sourced from 100 different sites, including the Inspira Medical Center Mullica Hill in Mullica Hill, Radiation Oncology Centers of Nevada Central in Las Vegas and Desert West Surgery in Grand Rapids."
Answered by AI
What potential risks do patients face when undergoing Quality-of-Life Assessment?
"Our team at Power assigned Quality-of-Life Assessment a safety score of 2 since the clinical trial is in its second phase. This indicates that there are some data supporting safety, yet no current evidence to suggest efficacy."
Answered by AI
To what kinds of diseases is Quality-of-Life Assessment most often applied?
"Quality-of-Life Assessment is a viable treatment option for malignant neoplasms, unresctable melanoma, and cases of microsatellite instability."
Answered by AI
How many participants are currently being admitted to this clinical investigation?
"Affirmative. Clinicaltrials.gov documents that this medical research, initiated on October 1st 2020, is presently recruiting participants. A total of 100 patients need to be enrolled at an assortment of clinical sites."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Louisiana
Other
Nevada
How old are they?
65+
What site did they apply to?
Presbyterian - Saint Lukes Medical Center - Health One
Ochsner LSU Health Monroe Medical Center
Oncology Hematology Care Inc-Kenwood
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
Recently the doctor told me that my treatment options are limited so I decided to fight the cancer rather bowing down to it. So I started searching for clinical trials which can help me and others in future.
PatientReceived 1 prior treatment
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