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- AcceleRET-Lung
Lungenstudie AcceleRET zu Pralsetinib bei 1L-RET-fusionspositivem metastatischem NSCLC
AcceleRET Lung Study of Pralsetinib for 1L RET Fusion-positive, Metastatic NSCLC
Krebs Tumor Neoplasien Atemwegs Neoplasien Lungenkrebs RET-fusion Non Small Cell Lung Cancer Stammzell- und embryonale Neoplasien Nicht-kleinzelliges Lungenkarzinom Lungenneoplasie Bronchogenes Karzinom Nervengewebsneoplasie Thorakale Neoplasien Kopf-Hals-Karzinom Neoplasien im Kopf- und Halsbereich
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Basisinformationen
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Studien-ID
NCT04222972, BO42864, 2019-002463-10,BLU-667-2303,2023-505035-12-00
Condition
RET-fusion Non Small Cell Lung Cancer, Lung Neoplasm, Carcinoma, Non-Small-Cell Lung, Respiratory Tract Neoplasms, Thoracic Neoplasms, Neoplasms by Site, Neoplasms, Lung Diseases, Respiratory Tract Disease, Carcinoma, Bronchogenic, Bronchial Diseases, Head and Neck Neoplasms, Adenocarcinoma, Carcinoma, Neoplasms by Histologic Type, Neoplasms, Germ Cell and Embryonal, Neoplasms, Nerve Tissue
Official Title
A Phase III, Randomized, Open-Label Study of Pralsetinib Versus Standard of Care for First-Line Treatment of RET Fusion-Positive, Metastatic Non-Small Cell Lung Cancer
Einschlusskriterien
All
≥18 Years
No
Inclusion Criteria
- Participant has pathologically confirmed, definitively diagnosed, locally advanced (not able to be treated with surgery or radiotherapy) or metastatic NSCLC and has not been treated with systemic anticancer therapy for metastatic disease.
- Participant must have a documented RET-fusion
- Participant has measurable disease based on RECIST 1.1 as determined by the local site Investigator/radiology assessment.
- Participant has an ECOG Performance Status of 0 or 1.
- Participant should not have received any prior anticancer therapy for metastatic disease.
- Participants can have received previous anticancer therapy (except a selective RET inhibitor) in the neoadjuvant or adjuvant setting but must have experienced an interval of at least ≥ 6 months from completion of therapy to recurrence.
- Participants that received previous immune checkpoint inhibitors in the adjuvant or consolidation following chemoradiation are not allowed to receive pembrolizumab if randomized in Arm B
- Participant is an appropriate candidate for and agrees to receive 1 of the Investigator choice platinum-based chemotherapy regimens if randomized to Arm B.
- For women of childbearing potential: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception.
- For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm.
Exclusion Criteria
- Participant's tumor has any additional known primary driver alterations other than RET, such as targetable mutations of EGFR, ALK, ROS1, MET, and BRAF. Investigators should discuss enrollment with Sponsor designee regarding co-mutations.
- Participant previously received treatment with a selective RET inhibitor.
- Participant received radiotherapy or radiosurgery to any site within 14 days before randomization or more than 30 Gy of radiotherapy to the lung in the 6 months before randomization.
- Participant with a history of pneumonitis within the last 12 months.
- Participant has CNS metastases or a primary CNS tumor that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease. If a participant requires corticosteroids for management of CNS disease, the dose must have been stable for the 2 weeks before Cycle 1 Day 1.
- Participant has had a history of another primary malignancy that has been diagnosed or required therapy within the past 3 years prior to randomization.
Diese Seite fasst Informationen von öffentlichen Studienregister-Websites wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. zusammen. Weitere Informationen zu dieser Studie finden Sie auf der Registerkarte „Für medizinische Fachkräfte" oder auf einer der Studienregister-Websites.
Die Informationen stammen direkt von Websites öffentlicher Register wie ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com usw. und wurden nicht modifiziert.
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