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Checkpoint Inhibitor
Nivolumab + Chemotherapy +/- Radiation for Lung Cancer (CA209-6K6 Trial)
Phase 2
Recruiting
Led By Brendon Stiles, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Age > 18 years at time of study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 3 cycles. each cycle is defined as 3 weeks
Awards & highlights
CA209-6K6 Trial Summary
This trial tests how adding radiation therapy to chemo and immune therapy affects outcomes for lung cancer patients.
Who is the study for?
Adults over 18 with resectable stage IIA to IIIB non-small cell lung cancer, who haven't had previous lung cancer treatment. They must be able to undergo radiation therapy if needed, have a good performance status (ECOG 0 or 1), and agree to use effective birth control. Excluded are those on recent immunosuppressants, with certain allergies or autoimmune diseases, active infections like TB or hepatitis B/C, pregnant/breastfeeding women, and anyone with another primary malignancy.Check my eligibility
What is being tested?
This study is testing the effectiveness of Nivolumab (an immunotherapy drug) combined with chemotherapy before surgery in patients with early-stage non-small cell lung cancer. Some participants will also receive stereotactic body radiation therapy. The goal is to see if these treatments can improve outcomes when given before tumor removal.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation in various organs including lungs (pneumonitis), liver problems, skin reactions, hormone gland issues (like thyroiditis), and infusion reactions. Chemotherapy can lead to fatigue, nausea/vomiting, hair loss and increased risk of infection.
CA209-6K6 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am older than 18 years.
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My lung tumor can be treated with targeted radiation therapy.
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I have not received any treatment for my lung cancer.
CA209-6K6 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after 3 cycles. each cycle is defined as 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 3 cycles. each cycle is defined as 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete Pathological Response
Secondary outcome measures
Event Free Survival
Major Pathological Response
CA209-6K6 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3)Experimental Treatment3 Interventions
SBRT will be delivered near the conclusion of cycle 1 with platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. The intent is to deliver SBRT on three consecutive days when the concentration of radiosensitizing chemotherapy agents in the subject's system is at a minimum, to minimize toxicity risks. It is expected that some subjects may not receive SBRT on three consecutive days due to machine breakdown, inclement weather, or other logistic issues. Subjects must not receive SBRT within 72 hours after a cisplatin or carboplatin infusion
Group II: Nivolumab + Platinum Doublet ChemotherapyActive Control2 Interventions
All participants will receive platinum-based doublet chemotherapy (PDC) along with nivolumab for 3 cycles every 3 weeks. Carboplatinum (AUC=5) can be used instead of Cisplatin (75 mg/m2) from cycle 2 for Cisplatin induced neuro/oto/nephrotoxicity as long as the subject remains eligible for doublet chemotherapy. Participants with nonsquamous tumors will receive pemetrexed (500 mg/m2). Participants with squamous tumors will receive either docetaxel (75 mg/m2 on day 1) or gemcitabine (1000 mg/m2 on days 1, 8). Cycles will be every 3 weeks and a maximum of a 2 week delay will be permitted for resolution of toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include immunotherapy, chemotherapy, and targeted therapy. Immunotherapy, such as Nivolumab, works by inhibiting the PD-1 pathway, which helps the immune system recognize and attack cancer cells.
This is crucial for NSCLC patients as it can lead to more effective and durable responses compared to traditional treatments. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects.
Targeted therapy focuses on specific genetic mutations within cancer cells, such as EGFR or ALK mutations, and blocks the growth and spread of these cells. Understanding these mechanisms helps in selecting the most appropriate treatment based on the patient's specific cancer characteristics, potentially improving outcomes and minimizing side effects.
Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.
Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
446 Previous Clinical Trials
582,722 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,857 Total Patients Enrolled
Brendon Stiles, MDPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My lung cancer is at a specific stage and I am eligible for surgery aimed at curing it.I do not have active infections like TB, hepatitis B, or hepatitis C.I haven't taken strong immune system suppressing drugs in the last 14 days, except for minor exceptions like creams or low-dose steroids.I have had an autoimmune or inflammatory disorder but no active diverticulitis in the last 3 months.I am not pregnant or breastfeeding and agree to use birth control during and up to 90 days after treatment.I haven't received any cancer treatment in the last 30 days.I have another type of cancer, but it's not active.You have had a bad reaction to nivolumab or any of its ingredients in the past.I am older than 18 years.My lung tumor can be treated with targeted radiation therapy.You have a disease that can be measured using a specific method called RECIST v1.1.I have a history of lung conditions like interstitial lung disease or pneumonitis.I have previously received immunotherapy.I have moderate to severe nerve damage.My organs and bone marrow are functioning well.I have not received any treatment for my lung cancer.You have had an organ transplant from someone else.
Research Study Groups:
This trial has the following groups:- Group 1: Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3)
- Group 2: Nivolumab + Platinum Doublet Chemotherapy
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.
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