2022 World Conference on Lung Cancer (ePosters)-EP07.01-018. Phase III Randomized Trial on Surgery, Chemo and Pleural Radiation (IMPRINT) for Resectable Pleural Mesothelioma (NRG LU-006)

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The document discusses a Phase III randomized trial of pleurectomy/decortication (P/D) plus chemotherapy for malignant pleural mesothelioma (MPM) with or without adjuvant hemithoracic intensity-modulated pleural radiation therapy (IMPRINT). P/D is a lung-sparing surgical approach for MPM, and chemotherapy is delivered either before or after the surgery. Adjuvant IMPRINT was found to be safe and showed promising survival outcomes in a phase II study. The objective of the Phase III trial is to evaluate the efficacy of this trimodality treatment approach for resectable MPM.<br /><br />The study aims to improve median overall survival from 12 months to 20 months. Secondary objectives include measuring local failure-free, distant metastases-free, and progression-free survival, as well as assessing toxicities and quality of life. Exploratory objectives involve identifying biomarkers as predictors of response and evaluating the accuracy of clinical staging. The study will also examine the use of a RapidPlan model for faster treatment planning.<br /><br />Eligibility criteria for the study include stage I-IIIA MPM, suitability for P/D, age between 18 and 80 years, Karnofsky performance status of at least 80%, and satisfactory lung function. Exclusion criteria include sarcomatoid histology, continuous oxygen use, uncontrollable third space fluid, and certain medical illnesses.<br /><br />The study design involves the randomization of 140 eligible patients to receive either adjuvant IMPRINT or no adjuvant IMPRINT. Group sequential stopping rules will be applied to assess efficacy or futility, and outcomes will be calculated from the time of randomization. Stratification factors include histology, resection status, and type of chemotherapy.<br /><br />NRG LU-006, the study, is currently open to accrual with a target of 150 patients. It is the first NRG Oncology randomized phase III trial on MPM and evaluates the use of IMPRINT following P/D and chemotherapy.<br /><br />The document also provides information about the study status, sponsor acknowledgments, study schema example, and approved sites. Amendments have been made to allow for systemic therapy to be delivered locally and to include neoadjuvant systemic therapy prior to enrollment.<br /><br />In conclusion, the document presents the details of a Phase III trial evaluating the efficacy of P/D plus chemotherapy with or without adjuvant IMPRINT for resectable MPM. The study aims to improve overall survival and assess various secondary and exploratory objectives.

Asset Subtitle

Andreas Rimner

Meta Tag

Speaker Andreas Rimner

Topic Mesothelioma, Thymoma, and Other Thoracic Malignancies - Clinical

Keywords

Phase III trial

pleurectomy/decortication

chemotherapy

malignant pleural mesothelioma

adjuvant hemithoracic intensity-modulated pleural radiation therapy

IMPRINT

lung-sparing surgical approach

trimodality treatment approach

resectable MPM

overall survival