The RAPTOR Trial: Radiation with Atezolizumab for Extensive Small Cell Lung Cancer
This study, called the RAPTOR trial, is testing if adding radiation therapy to the usual immune therapy treatment, atezolizumab, works better than atezolizumab alone for extensive stage small cell lung cancer. This is for people whose cancer has spread and who have already received atezolizumab plus chemotherapy. Atezolizumab is an immunotherapy that helps your body's immune system fight cancer. Radiation therapy uses high-energy X-rays to kill cancer cells. Researchers want to see if combining these treatments can extend the time your cancer is controlled or improve how long you live. You may be able to join if you are 18 or older, have extensive stage small cell lung cancer, and your cancer has responded well to previous treatment with atezolizumab and chemotherapy. The study aims to enroll 138 participants, but its current status is unclear.
- Study design
- This is an interventional study comparing two treatment arms: atezolizumab plus radiation therapy versus atezolizumab alone. It plans to enroll 138 participants.
- What's involved
- You would receive atezolizumab intravenously (IV) every 21 days. You would also undergo blood and tissue collection, CT scans, MRI scans, and PET scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival and overall survival will be assessed for up to 6 years after randomization.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04402788
Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~138 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:AtezolizumabBiospecimen CollectionComputed TomographyMagnetic Resonance ImagingPositron Emission TomographyRadiation Therapy
At a glance
Recruiting sites
270 of 415 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-free survival (PFS) (Phase II)
Measured over From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years
+1 more outcome measured
Conditions
Where it's being run
415 sites across 48 statesPennsylvania57
Illinois35
Michigan31
Ohio27
Wisconsin20
Iowa16
North Carolina16
South Carolina15
Study leadership
- Quynh-Nhu Nguyen · PRINCIPAL_INVESTIGATOR · NRG Oncology
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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)
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x ULN (AST and/or ALT =\< 5 ULN for patients with liver involvement) (within 14 days prior to registration)
Alkaline phosphatase =\< 2.5 x ULN (=\< 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)
Adequate renal function = Creatinine clearance \>=40 mL/min by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)
Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture
Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily
For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.
Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion
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);
Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of \> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary;
Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
History of recent myocardial infarction within 6 months prior to registration.
Clinically significant interstitial lung disease
Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Women who are breastfeeding and unwilling to discontinue
History of allogeneic organ transplant
Patients who have had immunotherapy-induced pneumonitis
What this trial measures
- Progression-free survival (PFS) (Phase II)From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years
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.
- Overall survival (OS) (Phase III)From randomization to the date of death due to any cause, assessed up to 6 years
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.