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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
Pathologically proven diagnosis of limited stage small cell lung cancer within 60 days prior to registration
Received one cycle of platinum/etoposide chemotherapy pre-registration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Study 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.Check my eligibility
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.See study design
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 was diagnosed with early-stage small cell lung cancer in the last 60 days.
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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 had a PET/CT scan for cancer staging within the last 60 days.
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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.
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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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My kidney function, measured by creatinine clearance, is adequate.
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I am HIV-positive, on treatment, and my viral load is undetectable.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall survival (OS)
Secondary outcome measures
Blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB)
Distant metastases-free survival (DMFS)
Incidence of adverse events
+6 more
Other outcome measures
Patient-reported symptomatic toxicities

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (etoposide, cisplatin, carboplatin, 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 (etoposide, cisplatin, carboplatin, radiation therapy)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
Cisplatin
2013
Completed Phase 3
~1940
Carboplatin
2014
Completed Phase 3
~6670
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7160
Biospecimen Collection
2004
Completed Phase 1
~1850
Etoposide
2010
Completed Phase 3
~2440
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160

Find a Location

Who is running the clinical trial?

NRG OncologyOTHER
230 Previous Clinical Trials
100,109 Total Patients Enrolled
National Cancer Institute (NCI)Lead Sponsor
13,577 Previous Clinical Trials
41,223,854 Total Patients Enrolled
Kristin A HigginsPrincipal InvestigatorNRG Oncology

Media Library

3-Dimensional Conformal Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT03811002 — Phase 3
Small Cell Lung Cancer Research Study Groups: Arm I (etoposide, cisplatin, carboplatin, radiation therapy), Arm II (etoposide, cisplatin, carboplatin, radiation therapy)
Small Cell Lung Cancer Clinical Trial 2023: 3-Dimensional Conformal Radiation Therapy Highlights & Side Effects. Trial Name: NCT03811002 — Phase 3
3-Dimensional Conformal Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT03811002 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this city have a lot of options for this type of study?

"The University of Wisconsin Hospital and Clinics in Madison, Michigan, McLaren-Greater Lansing in Lansing, South dakota, and Marshfield Clinic Stevens Point Center in Stevens Point, Florida are all locations where this trial is currently being conducted. Additionally, there are 7 other sites."

Answered by AI

Are there any ongoing or previous investigations into Cisplatin?

"Currently, there are 1657 Cisplatin trials underway. 489 of these are Phase 3 clinical trials, which are the most advanced type of study. Most of these trials are based in Shanghai, but there are 86095 locations conducting research on Cisplatin around the world."

Answered by AI

How many people are participating in the clinical trial?

"In order to properly run this study, 545 patients that match the pre-determined inclusion criteria must enroll. These patients can come from several locations, such as University of Wisconsin Hospital and Clinics in Madison, Michigan and McLaren-Greater Lansing in Lansing, South dakota."

Answered by AI

What are the primary therapeutic applications for Cisplatin?

"Cisplatin is most frequently used to treat advanced head and neck cancer, however it can also be an effective medication for sarcoma, and other cancers that have not responded well to other treatments."

Answered by AI

Are you looking for more participants in this clinical trial?

"That is correct. The listing on clinicaltrials.gov indicates that the study is recruiting patients at this time. The posting dates you mentioned are accurate. Additionally, the trial is looking for 545 individuals total, to be recruited from 7 different hospitals or clinics."

Answered by AI
~208 spots leftby Dec 2026