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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.
Patient has histologically or cytologically proven clinical stages IIA (tumors > 4 cm), IIB, IIIA, and IIIB (T3 or T4, N2) NSCLC (AJCC version 8) and is considered eligible for surgical resection with curative intent. Patients with 2 primary non-small cell lung cancers are allowed.
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 below
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I am fully active or can carry out light work.
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My lung cancer is at a specific stage and I am eligible for surgery aimed at curing it.
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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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My organs and bone marrow are functioning well.
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I have not received any treatment for my lung cancer.

CA209-6K6 Trial 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

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

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
440 Previous Clinical Trials
581,559 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,631 Previous Clinical Trials
4,126,616 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, Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3)
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the research team enrolling in this experiment?

"Correct. Clinicaltrials.gov information reveals that this medical trial, which was introduced on January 17th 2023, is still actively enrolling patients. There are 52 participants needed from 1 specific site."

Answered by AI

Has the federal government sanctioned Nivolumab coupled with Platinum Doublet Chemotherapy and SBRT (8gy x 3)?

"The safety of Nivolumab + Platinum Doublet Chemotherapy + SBRT (8gy x 3) was assessed as a 2 since this is still in Phase 2, with no efficacy data but some existing information on its safety."

Answered by AI

Are there vacancies that participants can fill in this clinical trial?

"Correct. Clinicaltrials.gov confirms this clinical trial is currently recruiting suitable participants, the first posting being made on 17th January 2023 and most recently updated 27th December 2022. 52 people are required from one clinic centre for participation in the study."

Answered by AI
~27 spots leftby Jul 2025