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Checkpoint Inhibitor

Combination Immunotherapy for Small Cell Lung Cancer

Phase 2

Waitlist Available

Led By Anne Chiang, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Patients with measurable disease with at least one tumor site amenable to biopsy

Patients with ECOG performance status of 0 to 2

Must not have

Patients with an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids > dexamethasone 2 mg daily (or equivalent dose of other corticosteroids) or other immunosuppressive agents.

Interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment in patients who have already received chemotherapy for small cell lung cancer.

Who is the study for?

This trial is for patients with recurrent extensive stage small cell lung cancer (SCLC) after platinum-based chemotherapy. Eligible participants may have treated brain metastases, an ECOG performance status of 0 to 2, and measurable disease. Excluded are those with HIV/HBV/HCV, recent major surgery or trauma, pregnant or lactating women, active autoimmune diseases requiring treatment in the past 3 months, untreated symptomatic CNS metastases, and recent other treatments.

What is being tested?

The study tests a combination immunotherapy using Ipilimumab and Nivolumab on SCLC patients who've had disease progression post-platinum therapy. It aims to assess changes in tumor immune cells ratio and clinical benefits from the treatment.

What are the potential side effects?

Potential side effects include immune-related reactions such as inflammation in various organs including lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies), skin rash; fatigue; infusion reactions; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have a tumor that can be biopsied.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not taken high doses of steroids or immunosuppressants for an autoimmune disease in the last 3 months.

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I have lung disease that causes symptoms or could affect lung-related side effects from treatment.

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I have not had major surgery or a serious injury in the last 4 weeks.

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I am not pregnant or breastfeeding.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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

Change in the ratio of Teff/Treg cells

Secondary study objectives

Duration of response

Progression-free survival

Response rate

Other study objectives

Change in ctDNA

Change in tumor microenvironment

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab and IpilimumabExperimental Treatment1 Intervention

Patients will be treated with nivolumab 1 mg/kg and ipilimumab 3 mg/kg, starting on Day 1. Patients will receive 4 doses of each nivolumab and ipilimumab and then will receive nivolumab 240 mg starting week 13 (day 85) every 2 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.

0 / 7Eligibility criteria met