← 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

Must not have

Unstable angina, congestive heart failure, recent myocardial infarction, or clinically significant interstitial lung disease

Known immunosuppressive disease or chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 HIV is stable and I am on effective treatment.

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...

My cancer can be measured, has 3 or fewer liver spots, and isn't getting worse.

Exclusion Criteria

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

Select...

I do not have recent heart issues or significant lung disease.

Select...

I have a condition that weakens my immune system or COPD needing long-term oral steroids.

Select...

I do not have severe illnesses like active TB or serious liver disease.

Select...

I have had an organ transplant or lung inflammation from immunotherapy.

Select...

I do not have another cancer that could affect this treatment's safety or results.

Select...

My cancer has spread to my liver or heart, or I have more than 10 areas where cancer has spread.

Select...

I have had radiation therapy in my chest area that overlapped.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

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

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

Primary study objectives

Overall survival (OS) (Phase III)

Progression-free survival (PFS) (Phase II)

Secondary study objectives

Incidence of adverse events

Neoplasms

PFS (Phase III)

+1 more

Other study objectives

Tumor burden

Awards & Highlights

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 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

2011

Completed Phase 2

~2200

Atezolizumab

2016

Completed Phase 3

~5860