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 36 months

Awards & highlights

Summary

This trial is testing a new cancer treatment on patients who haven't responded to other treatments. It's divided into two parts, with the first part testing different doses to see what's safe and effective.

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.Check my eligibility

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.See study design

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 ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase I: Maximum Tolerated Dose (MTD)

Phase II: Progression-Free Survival (PFS)

Secondary outcome measures

1-year Overall Survival

6-Month Progression-Free Survival

Assess Adverse Events

+4 more

Side effects data

From 2018 Phase 2 trial • 55 Patients • NCT04345900

38%

Alopecia

31%

Leukopenia

23%

Neutropenia

15%

Nausea

15%

Tachycardia

15%

Sinus Tachycardia

Anaemia

Constipation

Respiratory Tract Infection Viral

Asthma

White Blood Cell Count Decreased

Cardiac Failure

Blood Glucose Increased

Abdominal Pain

Dysgeusia

Bone Pain

Myocardial Ischaemia

Myalgia

Viral Infection

Thrombocytopenia

Pain in Extremity

Non-Cardiac Chest Pain

Dizziness

Complex Regional Pain Syndrome

Neuropathy Peripheral

Atrial Fibrillation

Respiratory Failure

Retching

Decreased Appetite

Fatigue

Myocardial Firbrosis

100%

80%

60%

40%

20%

Study treatment Arm

Arm 1

Arm 2

Arm 3

Arm 4

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

Ipilimumab

2014

Completed Phase 3

~2610

Nivolumab

2014

Completed Phase 3

~4740

Plinabulin

2017

Completed Phase 3

~280

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.

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,652 Previous Clinical Trials

4,130,710 Total Patients Enrolled

Rutgers Cancer Institute of New JerseyOTHER

70 Previous Clinical Trials

18,718 Total Patients Enrolled

Jyoti MalhotraLead Sponsor

~6 spots leftby Jul 2025

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