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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
Must not have
Receipt of the last dose of therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, or other investigational agent) for an accepted other malignancy as defined in Section 3.3.2 within 30 days prior to the first dose of study drug for lung cancer.
Active other primary malignancy excepting:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 3 cycles. each cycle is defined as 3 weeks
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't received any cancer treatment in the last 30 days.
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I have another type of cancer, but it's not active.
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I have a history of lung conditions like interstitial lung disease or pneumonitis.
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I have previously received immunotherapy.
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I have moderate to severe nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 3 cycles. each cycle is defined as 3 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 3 cycles. each cycle is defined as 3 weeks for reporting.

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

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
~4740

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.

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
447 Previous Clinical Trials
582,872 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,697 Total Patients Enrolled
Brendon Stiles, MDPrincipal InvestigatorMontefiore Medical Center

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05500092 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3), Nivolumab + Platinum Doublet Chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT05500092 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05500092 — Phase 2
~20 spots leftby Jul 2025