Testing the Addition of High Dose, Targeted Radiation to the Usual Treatment for Locally-Advanced Inoperable Non-small Cell Lung Cancer
Locally Advanced Lung Non-Small Cell Carcinoma, Stage IIB Lung Cancer AJCC v8, Stage III Lung Cancer AJCC v8
About this trial
This is an interventional treatment trial for Locally Advanced Lung Non-Small Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of stage II or III (American Joint Committee on Cancer [AJCC] eighth edition) non-small cell lung cancer (NSCLC) with known PD-L1 status prior to registration Patients must have an identified primary tumor and at least one nodal metastasis (peribronchial/hilar/intrapulmonary, mediastinal/subcarinal, supraclavicular/scalene) Up to 4 cycles of systemic therapy received prior to registration for the current study cancer is allowable; any prior chemotherapy for a different cancer is also permissible The patient must be deemed clinically appropriate for curative intent definitive combined modality therapy, based on the following staging assessments: History/physical examination prior to registration; Magnetic resonance imaging (MRI) scan of the brain (preferred) or CT scan of the brain (if available, contrast is preferred for all neuroimaging) prior to registration; CT chest with IV contrast (if contrast is available and unless contraindicated, such as for abnormal kidney function) prior to registration. PET/CT may be used if the CT portion is of identical diagnostic quality as achieved in a stand-alone CT No evidence of distant metastases based on FDG PET/CT scan obtain within 60 days of registration Primary tumor =< 7 cm Age >= 18 Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Hematologic function (e.g. platelets, leukocytes, hemoglobin) amenable, at the discretion of the treating physician, to allow for treatment with chemotherapy and concurrent radiation therapy Creatinine clearance >= 25 mL/min by the Cockcroft-Gault (C-G) equation Subjects with non-malignant pleural effusion are eligible provided the effusion is not known or demonstrated to be an exudative effusion If a pleural effusion is present, the following criteria must be met to exclude malignant involvement: When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative; Effusions that are minimal (i.e., not visible on chest x-ray) that are too small to safely tap are eligible Medical history consistent with the patient being amenable, at the discretion of the treating physician, to allow for treating with consolidation immunotherapy. Patients with known EGFR/ALK mutation at the time of registration are eligible, and these patients can be treated with consolidation durvalumab or chemotherapy at the discretion of the treating physician Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen Negative pregnancy test =< 14 days prior to registration for participants of childbearing potential The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information Exclusion Criteria: Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields that is determined by the treating physician to impede the treatment of the study malignancy Patients without identifiable primary tumor and at least 1 pathologically enlarged lymph node are not eligible (T3-4N0 or T0N1-3 patients are not eligible). At least 1 radiographically-involved lymph node is required, but pathologic confirmation of involvement is not mandated Centrally located primary tumor < 2 cm from involved nodal disease which would result in significant overlap of the primary SBRT and nodal radiation fields. Centrally located is defined as within or touching the zone of the proximal bronchial tree, which is a volume 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi) Participants who are pregnant or unwilling to discontinue nursing Participants of childbearing potential (participants who may become pregnant or who may impregnate a partner) unwilling to use highly effective contraceptives during therapy and for the Food and Drug Administration (FDA)-labeled contraception timeframe required after the final dose of the selected chemotherapy regimen, because the treatment in this study may be significantly teratogenic
Sites / Locations
- Banner University Medical Center - TucsonRecruiting
- University of Arizona Cancer Center-North CampusRecruiting
- Mills-Peninsula Medical CenterRecruiting
- Los Angeles County-USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- Fremont - Rideout Cancer CenterRecruiting
- Mills Health CenterRecruiting
- Rush - Copley Medical CenterRecruiting
- Illinois CancerCare-BloomingtonRecruiting
- Illinois CancerCare-CantonRecruiting
- Illinois CancerCare-CarthageRecruiting
- Centralia Oncology ClinicRecruiting
- Carle at The RiverfrontRecruiting
- Cancer Care Specialists of Illinois - DecaturRecruiting
- Decatur Memorial HospitalRecruiting
- Carle Physician Group-EffinghamRecruiting
- Crossroads Cancer CenterRecruiting
- Illinois CancerCare-EurekaRecruiting
- Illinois CancerCare-GalesburgRecruiting
- Illinois CancerCare-Kewanee ClinicRecruiting
- Illinois CancerCare-MacombRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Cancer Care Center of O'FallonRecruiting
- Illinois CancerCare-Ottawa ClinicRecruiting
- Illinois CancerCare-PekinRecruiting
- Illinois CancerCare-PeoriaRecruiting
- Methodist Medical Center of IllinoisRecruiting
- Illinois CancerCare-PeruRecruiting
- Illinois CancerCare-PrincetonRecruiting
- Southern Illinois University School of MedicineRecruiting
- Springfield ClinicRecruiting
- Memorial Medical CenterRecruiting
- Carle Cancer CenterRecruiting
- Illinois CancerCare - WashingtonRecruiting
- Medical Oncology and Hematology Associates-West Des MoinesRecruiting
- Iowa Methodist Medical CenterRecruiting
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Mission Cancer and Blood - LaurelRecruiting
- Ascension Via Christi Hospitals WichitaRecruiting
- Saint Joseph Mercy HospitalRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Sparrow HospitalRecruiting
- Trinity Health Saint Mary Mercy Livonia HospitalRecruiting
- 21st Century Oncology-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Saint Francis Medical CenterRecruiting
- Mercy Hospital SouthRecruiting
- Mercy Hospital Saint LouisRecruiting
- Renown Regional Medical CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Wilmot Cancer Center at BataviaRecruiting
- Montefiore Medical Center-Einstein CampusRecruiting
- Montefiore Medical Center-Weiler HospitalRecruiting
- Montefiore Medical Center - Moses CampusRecruiting
- Sands Cancer CenterRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- New York Proton CenterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Wilmot Cancer Institute Radiation Oncology at GreeceRecruiting
- Highland HospitalRecruiting
- University of RochesterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Westchester Medical CenterRecruiting
- Wilmot Cancer Institute at WebsterRecruiting
- Atrium Health Stanly/LCI-AlbemarleRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Novant Health Presbyterian Medical CenterRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Atrium Health University City/LCI-UniversityRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- CaroMont Regional Medical CenterRecruiting
- Novant Health Cancer Institute - HuntersvilleRecruiting
- Novant Health Presbyterian Medical Center HuntersvilleRecruiting
- Levine Cancer Institute - Union WestRecruiting
- Novant Health Cancer Institute - MatthewsRecruiting
- Atrium Health Union/LCI-UnionRecruiting
- Novant Health Cancer Institute - MooresvilleRecruiting
- Atrium Health Cleveland/LCI-ClevelandRecruiting
- Mercy Health Perrysburg Cancer CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Chambersburg HospitalRecruiting
- Ephrata Cancer CenterRecruiting
- Adams Cancer CenterRecruiting
- Sechler Family Cancer CenterRecruiting
- Reading HospitalRecruiting
- WellSpan Health-York Cancer CenterRecruiting
- WellSpan Health-York HospitalRecruiting
- Rock Hill Radiation Therapy CenterRecruiting
- Levine Cancer Institute-Rock HillRecruiting
- MD Anderson in The WoodlandsRecruiting
- M D Anderson Cancer CenterRecruiting
- MD Anderson West HoustonRecruiting
- MD Anderson League CityRecruiting
- MD Anderson in Sugar LandRecruiting
- Langlade Hospital and Cancer CenterRecruiting
- Zablocki Veterans Administration Medical CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Ascension Saint Mary's HospitalRecruiting
- Ascension Saint Michael's HospitalRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aspirus Regional Cancer CenterRecruiting
- Aspirus Cancer Care - Wisconsin RapidsRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Arm I (image guided RT, chemotherapy, immunotherapy)
Arm II (SBRT, image guided RT, chemotherapy, immunotherapy)
Patients undergo conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.
Patients undergo SBRT and conventional IGRT and receive standard of care chemotherapy consisting of paclitaxel IV and carboplatin IV or pemetrexed IV and carboplatin IV or etoposide IV and cisplatin IV or pemetrexed IV and cisplatin IV and then receive durvalumab IV on study. Patients also undergo CT and/or PET/CT during follow up.