Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial
Launched by NATIONAL CANCER INSTITUTE (NCI) · May 22, 2020
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
The RAPTOR Trial is a clinical study looking at whether adding radiation therapy to the usual treatment with atezolizumab can help patients with extensive stage small cell lung cancer. This type of cancer has spread beyond the lungs, and atezolizumab is a type of treatment that helps the immune system fight the cancer. The goal of the trial is to see if combining radiation with atezolizumab can help keep the cancer from growing or spreading for a longer time compared to using atezolizumab alone.
To be eligible for this trial, participants must have been diagnosed with extensive stage small cell lung cancer and have shown either a partial response or stable disease after receiving chemotherapy and atezolizumab. Patients should also have a good performance status, meaning they are generally able to carry out daily activities. Throughout the trial, participants will continue receiving atezolizumab and will also receive radiation therapy if they qualify. It’s important to note that women who can become pregnant must use effective contraception during the study and for several months afterward. This trial is currently recruiting participants, and those interested should speak with their healthcare provider to see if they qualify.
Gender
ALL
Eligibility criteria
- 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 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 Criteria:
- • 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
About National Cancer Institute (Nci)
The National Cancer Institute (NCI) is a prominent component of the National Institutes of Health (NIH), dedicated to advancing cancer research and improving patient outcomes through innovative clinical trials. As a leading sponsor of cancer-related studies, NCI focuses on facilitating the development of new therapies, enhancing prevention strategies, and understanding the biology of cancer. The institute collaborates with academic institutions, healthcare providers, and industry partners to conduct rigorous clinical trials that aim to translate scientific discoveries into effective treatments. NCI’s commitment to fostering a robust research environment supports the mission to eliminate cancer as a major health problem.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Haven, Connecticut, United States
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Indiana, Pennsylvania, United States
Monroeville, Pennsylvania, United States
New Castle, Pennsylvania, United States
Washington, Pennsylvania, United States
Williamsport, Pennsylvania, United States
Newnan, Georgia, United States
Westerly, Rhode Island, United States
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Gastonia, North Carolina, United States
Pierre, South Dakota, United States
'Aiea, Hawaii, United States
Nampa, Idaho, United States
Springfield, Illinois, United States
Sheboygan, Wisconsin, United States
Yankton, South Dakota, United States
Matthews, North Carolina, United States
Des Moines, Iowa, United States
Allentown, Pennsylvania, United States
Lebanon, New Hampshire, United States
Nampa, Idaho, United States
Brighton, Michigan, United States
Chelsea, Michigan, United States
Dayton, Ohio, United States
Danville, Illinois, United States
Guilford, Connecticut, United States
Quakertown, Pennsylvania, United States
Greenville, Ohio, United States
Canton, Michigan, United States
Rhinelander, Wisconsin, United States
Stevens Point, Wisconsin, United States
Minocqua, Wisconsin, United States
Columbia, Missouri, United States
Stroudsburg, Pennsylvania, United States
Greenville, Pennsylvania, United States
Ankeny, Iowa, United States
Sunset Hills, Missouri, United States
O'fallon, Illinois, United States
Des Moines, Iowa, United States
Clive, Iowa, United States
Lansing, Michigan, United States
Rockford, Illinois, United States
Silverdale, Washington, United States
Saint Johnsbury, Vermont, United States
Dayton, Ohio, United States
Dayton, Ohio, United States
Royal Oak, Michigan, United States
Irvine, California, United States
Troy, Michigan, United States
Millville, Delaware, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
Camillus, New York, United States
Southfield, Michigan, United States
Novi, Michigan, United States
Kalamazoo, Michigan, United States
Ankeny, Iowa, United States
Clive, Iowa, United States
Des Moines, Iowa, United States
Des Moines, Iowa, United States
Waukee, Iowa, United States
Union, South Carolina, United States
South Portland, Maine, United States
Portland, Maine, United States
Scarborough, Maine, United States
Patients applied
Trial Officials
Quynh-Nhu Nguyen
Principal Investigator
NRG Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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