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Atezolizumab + Chemoradiation for Small Cell Lung Cancer

Phase 3

Waitlist Available

Led By Kristin A Higgins

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Aged 18 or above

Had ECOG performance status of 0-2 within 30 days prior to registration

Must not have

Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields

Active hepatitis B or hepatitis C infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying how well chemotherapy and radiation therapy work with or without atezolizumab in treating patients with limited stage small cell lung cancer.

Who is the study for?

This trial is for adults with a confirmed diagnosis of limited stage small cell lung cancer. Participants must have had one cycle of specific chemotherapy, be in good physical condition (ECOG 0-2), and have proper organ function. Pregnant women, those with certain medical conditions or previous treatments like immunotherapy, and individuals not using contraception are excluded.

What is being tested?

The study is examining the effectiveness of adding Atezolizumab to standard chemoradiation therapy for treating small cell lung cancer. It compares outcomes between patients receiving usual treatment alone versus those also getting this new immunotherapy drug.

What are the potential side effects?

Atezolizumab may cause immune-related reactions, potential liver issues, fatigue, possible infusion-related symptoms, and could interfere with normal organ functions. Chemoradiation can lead to nausea, hair loss, skin changes at the radiation site and 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 am 18 years old or older.

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I was mostly active and able to care for myself within the last month.

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I have completed one cycle of platinum/etoposide chemotherapy.

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My cancer was measurable before starting specific chemotherapy.

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I've had a CT scan of my chest and abdomen or an MRI of my abdomen with contrast in the last 60 days.

Exclusion Criteria

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

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I've had radiation to my chest area that overlaps with new treatment areas.

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I have an active hepatitis B or C infection.

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I am not pregnant and willing to use contraception if of childbearing potential.

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I have received an organ from another person.

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I have a condition that weakens my immune system.

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I have a serious lung condition affecting the tissue and space around the air sacs.

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I have had more than one round of platinum-based chemotherapy for small cell lung cancer.

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I had surgery to remove small cell lung cancer.

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I have or had inflammatory bowel disease.

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I take more than 10 mg of prednisone daily for my COPD.

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I have previously received atezolizumab or another immunotherapy.

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My cancer has spread to other parts of my body.

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I have active tuberculosis.

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I have a significant liver condition.

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I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 3 months.

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I have an autoimmune disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall survival (OS)

Secondary study objectives

Distant metastases-free survival (DMFS)

Incidence of adverse events

Level of fatigue

+5 more

Other study objectives

Concordance between tumor and circulating cell free deoxyribonucleic acid (cfDNA) molecular subtypes

Patient-reported symptomatic toxicities

Treatment effect by ethnicity

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (chemotherapy, radiation therapy)Experimental Treatment8 Interventions

Patients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.

Group II: Arm II (chemotherapy, radiation therapy, atezolizumab)Active Control9 Interventions

Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6120

3-Dimensional Conformal Radiation Therapy

2010

Completed Phase 3

~7490