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NC318 + Pembrolizumab for Lung Cancer
Study Summary
This trial is testing NC318, a new cancer drug, either alone or with another cancer drug, pembrolizumab, to see if it can treat advanced non-small cell lung cancer.
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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- My cancer progressed or I couldn't tolerate treatment after a specific gene mutation.You have a disease that can be measured using specific criteria.My blood and organs are functioning well.I had a severe reaction to previous immunotherapy.My lung cancer is advanced or has spread to other areas.I am willing to have a biopsy on at least one of my tumors.I have had PD-1 inhibitor therapy and my cancer progressed afterwards.I haven't taken any immune-weakening drugs in the last 2 weeks.I have never received PD-1 axis inhibitor therapy.I had radiation therapy not targeting the brain within the last 2 weeks.I am fully active or can carry out light work.I have brain metastases that are causing symptoms or have not been treated.Your cancer cells have less than 50 percent PD-L1 expression.I have had cancer spread to the lining of my brain and spinal cord.
- Group 1: Arm 2 (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab
- Group 2: Arm 2a (naïve to PD-1 axis inhibitor)- NC318 and Pembrolizumab
- Group 3: Arm 1a - NC318 only
- Group 4: Arm 1b - NC318 and Pembrolizumab
- Group 5: Arm 1c - NC318 and Pembrolizumab
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What are the main goals that researchers hope to achieve with this clinical trial?
"The sponsor of this clinical trial, Merck Sharp & Dohme LLC, has stated that the primary objective for this study will be to measure tumor response over time in patients with NSCLC who have progressed on prior anti-PD-1 therapy. This will be done by assessing tumors at screening and every 8 weeks for the first 24 weeks and then every 12 weeks until initial disease progression is observed. The secondary objectives of this trial include measuring progression-free survival RECIST v1.1), overall survival (RECIST v1.1), and overall survival (RECIST v1.1) in two different patient groups: those"
Are there any more slots open for this experiment?
"That is correct. The clinical trial website has the most recent information on the status of this study, which is presently looking for 141 participants at 1 location."
What are some of the conditions that Pembrolizumab is used to treat?
"Pembrolizumab is a medication that can be used to treat several different cancers. In addition, this drug can also help patients who are experiencing disease progression after chemotherapy or those with unresectable melanoma and microsatellite instability high."
Could you give some examples of other research done on Pembrolizumab?
"Pembrolizumab is being trialled in 1000 separate studies, 122 of which are in Phase 3. Many of the Pembrolizumab trials are based out of Houston, Texas; however, there 36030 locations running these medical experiments."
Will Pembrolizumab have any long-term negative effects on patients?
"Pembrolizumab is a Phase 2 medication, which means that while there is some evidence to support its safety, there is none yet for efficacy. We've given it a score of 2."
How many human test subjects are a part of this clinical research?
"That is accurate, the website provides information that this study is looking for participants. The trial was posted on February 4th 2021 and updated on May 9th 2022. There is one site where 141 people will be enrolled in the trial."
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