NCT04402788|RecruitingPhase 2FDA Drug

Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial

RAndomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

3 other identifiers

NCI-2020-03472NRG-LU007U10CA180868

Study Type

interventional

Target

138

Locations

1 country

Sites

415

Timeline

RegisteredMay 2020

StartedJan 2021

CompletionApr 2027

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

138

participants targeted

Target at P75+ for phase_2

Timeline

13mo left

Started Jan 2021

Longer than P75 for phase_2

Geographic Reach

1 country

415 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.3 years study duration

Study Progress84%

Jan 2021Apr 2027

First Submitted

Initial submission to the registry

May 22, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed

8 months until next milestone

Study Start

First participant enrolled

January 7, 2021

Completed

6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

6.3 years

First QC Date

May 22, 2020

Last Update Submit

April 14, 2026

Conditions

Extensive Stage Lung Small Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

Progression-free survival (PFS) (Phase II)
Will compare the distributions of PFS between treatment arms using a one-sided stratified log-rank test in all randomized eligible patients. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Results from an unstratified analysis will also be provided.
From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years
Overall survival (OS) (Phase III)
Will compare arm I to arm 2 based on OS using a stratified log-rank test. Hazard ratios will be estimated using a stratified Cox regression model. Event rates over time will be estimated within each treatment group using the Kaplan-Meier method.
From randomization to the date of death due to any cause, assessed up to 6 years

Secondary Outcomes (6)

Incidence of adverse events
Up to 6 years
PFS (Phase III)
Up to 6 years
PFS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors
Up to 6 years
OS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors
Up to 6 years
PFS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease
Up to 6 years
+1 more secondary outcomes

Other Outcomes (1)

Tumor burden
Up to 6 years

Study Arms (2)

Arm I (atezolizumab)

ACTIVE COMPARATOR

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.

Drug: AtezolizumabProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography

Arm II (atezolizumab, radiation therapy)

EXPERIMENTAL

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.

Drug: AtezolizumabProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyRadiation: Radiation Therapy

Interventions

AtezolizumabDRUG

Given IV

Also known as: MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A, MPDL328OA, RG 7446, RG-7446, RG7446, RO 5541267, RO-5541267, RO5541267, Tecentriq

Arm I (atezolizumab)Arm II (atezolizumab, radiation therapy)

Biospecimen CollectionPROCEDURE

Undergo blood and tissue collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Arm I (atezolizumab)Arm II (atezolizumab, radiation therapy)

Computed TomographyPROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Arm I (atezolizumab)Arm II (atezolizumab, radiation therapy)

Magnetic Resonance ImagingPROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm I (atezolizumab)Arm II (atezolizumab, radiation therapy)

Positron Emission TomographyPROCEDURE

Undergo PET

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Arm I (atezolizumab)Arm II (atezolizumab, radiation therapy)

Radiation TherapyRADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation

Arm II (atezolizumab, radiation therapy)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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 receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)
NOTE: Patients must have at least 3 cycles of E/P plus atezolizumab. They can have one cycle of induction E/P without concurrent atezolizumab if unable to receive concurrent E/P combined with atezolizumab for all cycles of induction therapy
Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors \[RECIST\]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
At time of enrollment after induction E/P chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
Appropriate stage for study entry based on the following diagnostic workup:
History/physical examination within 14 days prior to registration;
Imaging within 42 days prior to registration to include:
MRI brain with contrast or CT brain with contrast
CT chest, abdomen and pelvis or whole body PET/CT scan any time after the fourth cycle of chemotherapy and prior to registration
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
Absolute neutrophil count (ANC) \>= 1,000/cells/mm\^3 (within 14 days prior to registration)
Platelets \>= 75,000 cells/mm\^3 (within 14 days prior to registration)
Hemoglobin \>= 8 g/dL (within 14 days prior to registration)
Total bilirubin =\< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
+11 more criteria

You may not qualify if:

Metastatic disease invading the liver (\> 3 metastases), heart or \> 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site
Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation
Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue
Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.
If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.
Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.
Severe, active co-morbidity defined as follows:
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
Active tuberculosis;
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible
Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test)
Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL);
+7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NRG Oncologycollaborator
National Cancer Institute (NCI)lead

Study Sites (415)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

ACTIVE NOT RECRUITING

Katmai Oncology Group

Anchorage, Alaska, 99508, United States

RECRUITING

Cancer Center at Saint Joseph's

Phoenix, Arizona, 85004, United States

RECRUITING

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054, United States

SUSPENDED

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

SUSPENDED

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

ACTIVE NOT RECRUITING

University of Arizona Cancer Center-North Campus

Tucson, Arizona, 85719, United States

ACTIVE NOT RECRUITING

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, 72401, United States

RECRUITING

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612, United States

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

ACTIVE NOT RECRUITING

Palo Alto Medical Foundation Health Care

Palo Alto, California, 94301, United States

SUSPENDED

Sutter Cancer Centers Radiation Oncology Services-Roseville

Roseville, California, 95661, United States

SUSPENDED

Sutter Medical Center Sacramento

Sacramento, California, 95816, United States

SUSPENDED

California Pacific Medical Center-Pacific Campus

San Francisco, California, 94115, United States

SUSPENDED

Palo Alto Medical Foundation-Sunnyvale

Sunnyvale, California, 94086, United States

SUSPENDED

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

SUSPENDED

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, 80907, United States

SUSPENDED

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

ACTIVE NOT RECRUITING

Memorial Hospital North

Colorado Springs, Colorado, 80920, United States

ACTIVE NOT RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

ACTIVE NOT RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, 80528, United States

ACTIVE NOT RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, 80631, United States

ACTIVE NOT RECRUITING

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

ACTIVE NOT RECRUITING

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, 06824, United States

RECRUITING

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, 06830, United States

RECRUITING

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, 06437, United States

RECRUITING

Smilow Cancer Hospital-Hamden Care Center

Hamden, Connecticut, 06518, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, 06473, United States

RECRUITING

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, 06902, United States

RECRUITING

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, 06790, United States

RECRUITING

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, 06611, United States

RECRUITING

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, 06708, United States

RECRUITING

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, 06385, United States

RECRUITING

Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States

RECRUITING

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

RECRUITING

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

RECRUITING

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

RECRUITING

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States

ACTIVE NOT RECRUITING

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, 33146, United States

RECRUITING

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, 33442, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

WITHDRAWN

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

ACTIVE NOT RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, 32806, United States

ACTIVE NOT RECRUITING

Cleveland Clinic-Weston

Weston, Florida, 33331, United States

ACTIVE NOT RECRUITING

Grady Health System

Atlanta, Georgia, 30303, United States

RECRUITING

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

RECRUITING

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

RECRUITING

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, 30265, United States

RECRUITING

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

SUSPENDED

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, 31405, United States

ACTIVE NOT RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza