RAndomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial
National Cancer Institute (NCI)
Summary
This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab 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). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.
Description
PRIMARY OBJECTIVES: I. To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase II) II. To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase III) SECONDARY OBJECTIVES: I. To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm. II. To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and \> 3 visible tumors. III. To assess the impact of adding radiotherapy on PFS and OS in patients re…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases * Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission tomography \[PET\]/computed tomography \[CT\] scan, diagnostic CT scan, magnetic resonance imaging \[MRI\] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide/platinum (if not r…
Interventions
- DrugAtezolizumab
Given IV
- ProcedureBiospecimen Collection
Undergo blood and tissue collection
- ProcedureComputed Tomography
Undergo CT
- ProcedureMagnetic Resonance Imaging
Undergo MRI
- ProcedurePositron Emission Tomography
Undergo PET
- RadiationRadiation Therapy
Undergo radiation therapy
Locations (415)
- University of Alabama at Birmingham Cancer CenterBirmingham, Alabama
- Katmai Oncology GroupAnchorage, Alaska
- Cancer Center at Saint Joseph'sPhoenix, Arizona
- Mayo Clinic Hospital in ArizonaPhoenix, Arizona
- Mayo Clinic in ArizonaScottsdale, Arizona
- Banner University Medical Center - TucsonTucson, Arizona