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AK112 for Non-Small Cell Lung Cancer
Study Summary
This trial tests a new drug combo for lung cancer that has resisted other treatments.
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.Trial Design
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Who is running the clinical trial?
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- I have brain metastases causing symptoms.I haven't had any cancer except for my current one or any cured local tumors in the past 3 years.I have received cancer treatment that is not EGFR-TKI.I am fully active or restricted in physically strenuous activity but can do light work.You are expected to live for at least 3 more months.I have not had a gastrointestinal perforation or fistula in the last 6 months.I have taken a 3rd generation EGFR-TKI treatment and my cancer progressed after that.I need frequent drainage for fluid buildup in my chest or abdomen.My tumor is affecting major blood vessels or nearby organs.My cancer is confirmed as small cell or mainly squamous cell carcinoma.My cancer has EGFR mutations.I have received treatments that target my cancer's immune response.My cancer has mutations that can be treated with specific drugs.I have had a major illness within the last year.I am 18 years old or older.I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.My non-squamous NSCLC is at an advanced stage and cannot be treated with surgery, radiotherapy, or chemotherapy.I have had specific cancer treatments within the last 2 weeks.My major organs are functioning well before starting treatment.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have had chest radiation therapy before starting this treatment.You have at least one tumor that can be measured and is not in the brain.
- Group 1: Ivonescimab (SMT112 or AK112) in combination with Pemetrexed and Carboplatin
- Group 2: Placebo in combination with Pemetrexed and Carboplatin
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is there any way for me to become involved in the research?
"It is necessary for prospective trial candidates to have non-small cell lung cancer and be between 18 and 75 years old in order to qualify. Currently, this medical experiment seeks 470 participants."
Is recruitment still open for involvement in this experiment?
"Affirmative. The information found on clinicaltrials.gov states that this study is actively recruiting participants, having first been posted in January 1st 2022 and last updated May 23rd 2023. To finish the trial it requires 470 individuals to be enrolled at 16 different medical sites."
Is this investigation extending its eligibility to those aged 70 or above?
"This experiment is only open to patients that are between 18 and 75 years old. The database reveals 20 clinical trials for minors and 1384 studies seeking elderly participants."
Are there establishments in Canada that are currently conducting research on this topic?
"Presently, this trial is taking place in 16 different medical facilities located across the country; Orange, Santa Rosa and Ocala being some of them. To reduce travelling obligations during your participation, it's recommended to select a clinic close by you."
What is the current participant count for this research endeavor?
"Affirmative, clinicaltrials.gov confirms that this medical study has been actively recruiting since its posting on 1/1/2022 and most recently updated on 5/23/2023. The trial is seeking 470 participants to be enrolled at 16 different sites."
Has the joint administration of AK112, Pemetrexed and Carboplatin been validated by regulatory authorities?
"Our experts at Power consider the combination of AK112, Pemetrexed and Carboplatin to be highly safe, judging it a 3 out of 3 due to prior clinical evidence backing its efficacy as well as multiple rounds validating safety."
What aim is this clinical trial intended to achieve?
"According to the research sponsors at Akeso, Progression-free Survival (PFS) is the primary outcome measure and will be monitored for up to two years. Additionally, secondary outcomes such as Incidence and severity of Adverse Events (AEs), Disease Control Rate (DCR), based on RECIST v1.1 criteria, as well as the Number of Subjects who develop Detectable Anti-Drug Antibodies (ADAs) are also being evaluated in this trial."
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