What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) involving PD-1 inhibitors like Nivolumab are associated with several side effects. These include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroid dysfunction), and skin reactions like rash and pruritus. Other notable side effects can include fatigue, diarrhea, and infusion-related reactions. In some cases, severe adverse events like grade 3 or 4 toxicities, including pneumonia and severe immune-related reactions, have been reported. It is crucial for patients to be closely monitored for these side effects during treatment.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) involve immune checkpoint inhibitors similar to Nivolumab, a PD-1 inhibitor. Pembrolizumab, another PD-1 inhibitor, has shown efficacy in combination with chemotherapy for advanced squamous NSCLC, improving overall survival (OS) and progression-free survival (PFS). Atezolizumab, a PD-L1 inhibitor, is approved for use in combination with chemotherapy for patients with advanced nonsquamous NSCLC without EGFR or ALK mutations, as demonstrated in the IMpower 150 trial. Additionally, Cemiplimab, a PD-1 inhibitor, has been approved for advanced NSCLC with high PD-L1 expression. These approvals highlight the role of immune checkpoint inhibitors in the treatment landscape of NSCLC.

What other types of research exist?

Promising alternatives to Nivolumab for NSCLC patients include Pembrolizumab (another PD-1 inhibitor) and Atezolizumab (a PD-L1 inhibitor). Combination therapies such as Pembrolizumab plus chemotherapy and Atezolizumab plus chemotherapy have shown higher response rates and longer progression-free survival compared to monotherapy. Additionally, Durvalumab combined with chemotherapy is an acceptable frontline option. These alternatives are supported by various clinical trials and meta-analyses indicating their efficacy and safety.

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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 a combination of nivolumab, chemotherapy, and sometimes targeted radiation in patients with a specific type of lung cancer that can be surgically removed. The treatment aims to shrink the tumor and kill cancer cells, making surgery more effective. Nivolumab with chemotherapy has been approved by the FDA as the first immunotherapy-based treatment for non-small cell lung cancer.

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.

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.

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 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Complete Pathological Response

Secondary study objectives

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

~5220

0 / 9Eligibility criteria met

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.