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Alkylating agents

Durvalumab + Radiation for Small Cell Lung Cancer

Phase 2

Recruiting

Led By Christine Bestvina, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

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

Must have

Body weight >30 kg

Patient is suitable to receive a platinum-based chemotherapy regimen as first line treatment for extensive stage small cell lung cancer

Must not have

Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent

Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will explore if combining radiation with durvalumab, carboplatin and etoposide can help treat extensive-stage small cell lung cancer. Participation lasts 48 months.

Who is the study for?

This trial is for adults over 18 with newly diagnosed extensive-stage small cell lung cancer that hasn't been treated yet. Participants must have a life expectancy of at least 12 weeks, be able to perform daily activities (ECOG status 0-2), and have tumors suitable for focused radiation. They should not be pregnant or breastfeeding, agree to use contraception, and cannot have had previous treatments like chemotherapy or certain immunotherapies for lung cancer.

What is being tested?

The study tests if adding ablative radiation therapy to the FDA-approved combination of durvalumab (an immunotherapy drug), carboplatin, and etoposide can improve survival without cancer progression in patients with extensive-stage small cell lung cancer. The treatment's effectiveness will be monitored over approximately four years.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, fatigue, nausea from chemotherapy drugs, potential blood disorders due to bone marrow suppression by carboplatin and etoposide, as well as skin irritation or damage to nearby tissues from radiation therapy.

Eligibility Criteria

Inclusion Criteria

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

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I weigh more than 30 kilograms.

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I am eligible for platinum-based chemotherapy as my first treatment for extensive small cell lung cancer.

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I can care for myself and am up and about more than 50% of my waking hours.

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My lung cancer has spread to other parts of my body.

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I have a tumor that can be measured and is suitable for targeted radiation therapy.

Exclusion Criteria

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

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I do not have any serious ongoing illnesses that could affect my participation in the study.

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I do not have active infections like TB, hepatitis B, C, or HIV.

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I have a condition related to my cancer that affects other parts of my body and requires strong medication.

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I have been treated with medications targeting PD-1/PD-L1 or CTLA4.

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I haven't had extensive radiation to my bone marrow or wide field radiation in the last 4 weeks.

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I haven't taken immunosuppressive drugs in the last 14 days.

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I've had significant radiation therapy to the area that will be treated in this trial.

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I have had treatments like chemotherapy or radiation for small cell lung cancer.

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I have or had an autoimmune or inflammatory disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 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

Progression-Free Survival of Participant Until Disease Progression or Death

Secondary study objectives

Overall Survival Rate of Participants After Treatment with Chemotherapy, Durvalumab and Ablative Radiation

Progression Free Survival at 12 Months

Rate of Participants with Grade 3/4 Adverse Events After 3 Months According to the Common Terminology Criteria for Adverse Events

+2 more

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: Participants With Extensive Small Cell Lung Cancer (All Participants)Experimental Treatment4 Interventions

This arm will involve all participants in the study who have extensive small cell lung cancer that has not responded to previous treatments. All participants will receive the same treatment of study drugs and radiation treatment in "cycles" (a specific window of time). You will receive up to four 21-day cycles of chemotherapy using carboplatin, etoposide and durvalumab (immunotherapy) as part of a standard care treatment plan recommended by your doctor. These drugs will be combined with ablative radiation treatment during the second cycle of chemotherapy. After completing these four cycles of chemotherapy (with radiation treatment added in cycle 2), you will continue to receive a fixed dose of durvalumab until your cancer progresses, you experience serious side effects, you decide to no longer be part of the study or the study doctor request to take you off the study for medical reasons.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Durvalumab

2017

Completed Phase 2

~3750

Carboplatin

2014

Completed Phase 3

~6120