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Small Molecule
Adagrasib +/- Nivolumab for Non-Small Cell Lung Cancer (Neo-Kan Trial)
Phase 2
Recruiting
Led By Kristen Marrone
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 90 days of surgery
Awards & highlights
Neo-Kan Trial Summary
This trial tests a new cancer drug combo to see if it's safe and effective for patients with a certain type of lung cancer.
Who is the study for?
Adults over 18 with stage IB-IIIA non-small cell lung cancer (NSCLC) and a specific KRAS G12C mutation can join. They must be candidates for potential curative surgery, not pregnant or breastfeeding, willing to use contraception, and have no history of certain diseases or treatments that could interfere with the trial.Check my eligibility
What is being tested?
The trial is testing Adagrasib alone or combined with Nivolumab in patients before surgery to see if it's safe and effective. It's an open-label phase 2 study which means everyone knows what treatment they're getting.See study design
What are the potential side effects?
Possible side effects include typical reactions from cancer therapies such as fatigue, nausea, liver enzyme changes, and immune-related conditions due to Nivolumab potentially affecting normal cells while targeting cancer.
Neo-Kan Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to have a KRAS G12C mutation.
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I am 18 years old or older.
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My biopsy was reviewed by a specialist and tissue is available for more tests.
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My blood and organ tests are within normal ranges for surgery.
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My cancer has a KRAS G12C mutation.
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My breast cancer is at a specific stage and has not spread to distant lymph nodes.
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I am fully active or can carry out light work.
Neo-Kan Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 90 days of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 90 days of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic complete response (pCR) rate
Neo-Kan Trial Design
2Treatment groups
Active Control
Group I: Arm AActive Control1 Intervention
Arm A treatment: Oral Adagrasib 600 mg twice daily for 6 weeks prior to surgery. Surgical Resection, then standard postoperative therapy(chemo +/- RT).
Group II: Arm BActive Control1 Intervention
Arm B treatment: Oral Adagrasib 400 mg twice daily for 6 weeks and IV Nivolumab 240mg every 2 weeks for 3 doses prior to surgery. Surgical Resection, then standard postoperative therapy(chemo +/- RT).
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,022 Total Patients Enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
558 Previous Clinical Trials
32,877 Total Patients Enrolled
Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
8,163 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My blood and organ tests are within normal ranges for surgery.I am not receiving treatment for any cancer except for certain skin cancers or early-stage cancers in specific areas.I have had radiation therapy to the chest area before.I have not received a live vaccine in the last 30 days.I do not have uncontrolled HIV or hepatitis, or if I do, it's undetectable and treated.My lung cancer cannot be removed by surgery.I am 18 years old or older.I have had a bone marrow transplant or have a primary immune system disorder.I have not had major surgery in the last 4 weeks.My lung cancer is confirmed to have a KRAS G12C mutation.I have had an autoimmune disease that needed treatment in the last 2 years.I have had treatments like chemotherapy or immunotherapy for lung cancer.I have had brain scans before joining this study.You have had a heart attack, unstable angina, or serious heart failure in the last 6 months, or you have certain heart rhythm problems or a prolonged QT interval. You also have conditions that may affect how the study drug works or affect your ability to absorb oral medications.My biopsy was reviewed by a specialist and tissue is available for more tests.My cancer has a KRAS G12C mutation.My breast cancer is at a specific stage and has not spread to distant lymph nodes.You are currently in prison or detained against your will for psychiatric or physical illness treatment.I am not pregnant or nursing.My lung cancer is at an early to mid-stage (Stage IB-IIIA).A surgeon believes surgery could potentially cure my condition.I am fully active or can carry out light work.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Arm A received federal authorization from the FDA?
"Our team at Power has assigned Arm A a safety rating of 2, as it is currently in Phase 2 trials. This implies that while there is data showing its security, the efficacy remains untested."
Answered by AI
Are any volunteers being accepted for this research endeavor?
"Per information accessible on clinicaltrials.gov, the recruitment of participants for this medical trial is underway. This research was initially posted to the website on March 21st 2023 and received its most recent update April 13th 2023."
Answered by AI
What is the overall enrollment figure for this experimental program?
"Affirmative. Per the information published on clinicaltrials.gov, this medical trial is currently seeking participants - it was originally posted in March of 2023 and its details were last updated on April 13th of that same year. 42 patients are needed across a single location for recruitment purposes."
Answered by AI
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