← Back to Search

Checkpoint Inhibitor

Radiation Therapy + Atezolizumab for Small Cell Lung Cancer

Phase 2 & 3
Recruiting
Led By Quynh-Nhu Nguyen
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
Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases
Patients with brain metastases are eligible after receiving whole brain radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

Study Summary

This trial will compare the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab (a monoclonal antibody) versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage).

Who is the study for?
This trial is for adults with extensive stage small cell lung cancer who've had some success (partial response or stable disease) after initial treatment with chemotherapy and Atezolizumab. They should have a good performance status, controlled HIV if present, no more than three liver metastases, and adequate organ function. Pregnant women, those with severe other diseases or conditions that could affect the trial's outcomes are excluded.Check my eligibility
What is being tested?
The RAPTOR trial is examining whether adding radiation therapy to standard immune therapy (Atezolizumab) improves outcomes in patients with extensive stage small cell lung cancer. It's a phase II/III study comparing the effects of combined radiation and Atezolizumab versus Atezolizumab alone after initial successful treatment.See study design
What are the potential side effects?
Possible side effects include typical reactions from immunotherapy like fatigue, skin reactions, potential autoimmune responses where the body attacks its own cells, as well as side effects from radiation such as skin burns, fatigue again, and possible damage to nearby organs depending on the site of radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My small cell lung cancer is confirmed and has spread.
Select...
I have had whole brain radiation for my brain metastases.
Select...
My cancer stage fits the study requirements based on tests and scans.
Select...
My HIV is stable and I am on effective treatment.
Select...
My blood, liver, and kidney functions are all within normal ranges.
Select...
My cancer is a type called extensive stage small cell lung cancer.
Select...
My cancer did not worsen after 4-6 cycles of specific chemotherapy and immunotherapy.
Select...
My cancer has spread to my liver with 3 or fewer spots and is not getting worse.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I can receive radiation for symptoms caused by cancer spread.
Select...
My cancer can be measured, has 3 or fewer liver spots, and isn't getting worse.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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) (Phase III)
Progression-free survival (PFS) (Phase II)
Secondary outcome measures
Incidence of adverse events
OS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease
Neoplasms
+3 more
Other outcome measures
Tumor burden

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (atezolizumab, radiation therapy)Experimental Treatment6 Interventions
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Group II: Arm I (atezolizumab)Active Control5 Interventions
Patients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2260
Atezolizumab
2016
Completed Phase 3
~6040
Biospecimen Collection
2004
Completed Phase 2
~1920
Computed Tomography
2017
Completed Phase 2
~2790
Magnetic Resonance Imaging
2017
Completed Phase 3
~1180
Radiation Therapy
2017
Completed Phase 3
~7250

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,257 Total Patients Enrolled
NRG OncologyOTHER
231 Previous Clinical Trials
100,714 Total Patients Enrolled
Quynh-Nhu NguyenPrincipal InvestigatorNRG Oncology
2 Previous Clinical Trials
278 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04402788 — Phase 2 & 3
Small Cell Lung Cancer Research Study Groups: Arm II (atezolizumab, radiation therapy), Arm I (atezolizumab)
Small Cell Lung Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04402788 — Phase 2 & 3
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04402788 — Phase 2 & 3

Frequently Asked Questions

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

Is this study mainly taking place in North American hospitals?

"Presently, this clinical trial is looking for patients from a pool of 100 different enrolment sites. Some of these sites are located in Danville, Des Moines, and Brighton. There are also many other sites which are closer to where potential patients might live. This is to reduce the amount of travel required, should somebody choose to enroll in the trial."

Answered by AI

Have other companies conducted similar research projects?

"Since its inception in 2008, Radiation Therapy has been the focus of many studies. The first was sponsored by Genentech, Inc and was published in 2008. After the success of the initial trial, which recruited 720 participants, Radiation Therapy received Phase 2 approval. Currently, there are 361 active trials being conducted in 1668 cities and 74 countries."

Answered by AI

What types of cancer does Radiation Therapy typically target?

"Radiation therapy can be used to target small cell lung cancer specifically, but it is also a viable treatment option for non-small cell lung carcinoma and postoperative patients."

Answered by AI

What other scientific papers have been published on the topic of Radiation Therapy?

"Radiation therapy was first studied in 2008 at National Cheng Kung Uni Hospital. There have been a total of 181 completed trials since then. Danville, Pennsylvania is currently conducting a significant number of the 361 live clinical trials."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
What site did they apply to?
UCHealth Greeley Hospital
Atrium Health Cabarrus/LCI-Concord
University of Cincinnati Cancer Center-UC Medical Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I've had chemotherapy, immunotherapy and whole brain radiation therapy but feel that I need more in my hope to live longer.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. University of Cincinnati Cancer Center-UC Medical Center: < 48 hours
Average response time
  • < 2 Days
~68 spots leftby Apr 2027