What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy agents such as etoposide and platinum compounds, and immune checkpoint inhibitors like nivolumab and ipilimumab. Chemotherapy often causes side effects such as nausea, vomiting, hair loss, fatigue, and increased risk of infection due to bone marrow suppression. Immune checkpoint inhibitors can lead to immune-related adverse events, including skin reactions, endocrine disorders, and more severe conditions like pneumonitis, hepatitis, and colitis. Combining these treatments can increase the frequency and severity of side effects, necessitating careful management and monitoring.

What prior FDA approvals exist?

The FDA has approved several treatments for Small Cell Lung Cancer (SCLC) that focus on immune response enhancement. Notably, nivolumab (Opdivo) and ipilimumab (Yervoy) are immune checkpoint inhibitors that have been approved for SCLC. These drugs work by enhancing the body's immune response against cancer cells. While there are no specific FDA approvals for microtubule destabilizers like Plinabulin in SCLC, the combination of immune checkpoint inhibitors with other therapies is a common approach in ongoing clinical trials.

What other types of research exist?

Promising novel alternatives to Plinabulin for SCLC patients include: 1) Nivolumab and Ipilimumab, which are being studied in combination with Plinabulin and have shown potential in immunotherapy. 2) Panobinostat, a histone deacetylase inhibitor, which has demonstrated modest clinical activity and a favorable safety profile in pretreated SCLC patients. 3) MLN4924, an indirect inhibitor of Cullin-RING Ligases, which is currently in several Phase I clinical trials and represents a novel mechanism of action targeting cancer cell proliferation.

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Checkpoint Inhibitor

Triple Therapy for Small Cell Lung Cancer

Phase 1 & 2

Waitlist Available

Led By Jyoti Malhotra, MD

Research Sponsored by Jyoti Malhotra

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to a maximum of 45 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of three drugs for patients with small cell lung cancer that has returned after earlier treatment. The drugs work together by stopping cancer growth and boosting the immune system to fight the cancer.

Who is the study for?

This trial is for adults over 18 with recurrent small cell lung cancer (SCLC) who have seen their disease progress after platinum-based chemotherapy. They must have tried a PD-1/PD-L1 therapy if entering Phase II, be in good health otherwise, and women of childbearing age must test negative for pregnancy and agree to use two forms of contraception.

What is being tested?

The study tests Nivolumab, Ipilimumab, and Plinabulin in patients with SCLC that came back after first-line treatment. It's an open-label trial meaning everyone knows what treatment they're getting. The first phase checks the right dose while the second phase looks at how well these drugs work together.

What are the potential side effects?

Possible side effects include immune-related reactions like inflammation in different organs, skin issues, hormone gland problems (endocrinopathies), fatigue, digestive disturbances such as diarrhea or colitis, liver enzyme changes indicating potential liver damage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to a maximum of 45 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to a maximum of 45 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to a maximum of 45 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Phase I: Maximum Tolerated Dose (MTD)

Progression-Free Survival (PFS)

Secondary study objectives

Clinical Benefit Rate

Number of Participants With Adverse Events

Number of Participants With Immune-related Adverse Events (irAEs)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase II: nivolumab, ipilimumab, and plinabulinExperimental Treatment3 Interventions

On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (MTD from Phase I). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur .

Group II: Phase I (Dose Escalation): nivolumab, ipilimumab and plinabulinExperimental Treatment3 Interventions

On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (escalating cohorts, IV). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur. Plinabulin escalation is as follows: Level -1 : 13.5mg/m\^2 Level 1 (start) : 20mg/m\^2 Level 2 : 30mg/m\^2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Ipilimumab

2015

Completed Phase 3

~3420

Plinabulin

2017

Completed Phase 3

~320

Do I qualify?Apply below to find out

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 Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and agents like Plinabulin. Chemotherapy drugs such as etoposide and cisplatin damage the DNA of cancer cells, leading to their death. Immunotherapy, including anti-PD-1 and anti-CTLA-4 antibodies, enhances the immune system's ability to target and destroy cancer cells. Plinabulin, a microtubule destabilizer and immune response enhancer, disrupts the microtubule network in cancer cells, causing cell cycle arrest and apoptosis, while also stimulating the immune system. These treatments are vital for SCLC patients due to the aggressive nature of the disease, necessitating therapies that can effectively eliminate cancer cells and boost immune response.