A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MeRmaiD 1)
- Conditions
- non small-cell lung cancerlung cancer10038666
- Registration Number
- NL-OMON54167
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
• Individuals who have diagnosis of histologically confirmed NSCLC (WHO 2015
classification) with resectable (stage II-III) disease
• A contrast-enhanced CT/MRI scan of the chest and abdomen (including liver and
adrenal glands) must have been done for surgical planning prior to surgery
• Complete resection of the primary NSCLC is mandatory
• Confirmation of suitable resected tumor tissue and whole blood sample
• Post-operative CT scan of the chest and abdomen
• Adequate organ and marrow function
• Eligible to tolerate 4 cycles of platinum-based adjuvant chemotherapy
• Must have a life expectancy of at least 12 weeks
• Unequivocal evidence of disease recurrence or tissue biopsy-proven disease
recurrence
• EGFR-mutant and/or ALK-translocation
• Mixed small cell and NSCLC histology
• Require re-resection or are deemed to have unresectable NSCLC by a
multidisciplinary evaluation that must include a thoracic surgeon who performs
lung cancer surgery as a significant part of their practice.
• Patients who are candidates to undergo only wedge resections
• Active or prior documented autoimmune or inflammatory disorders
• Uncontrolled intercurrent illness (see protocol page 67)
• History of another primary malignancy (check for exceptions)
• History of active primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, hepatitis C virus or HIV
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer
treatment (check for exceptions)
• Current or prior use of immunosuppressive medication within 14 days before
the first dose of durvalumab (check for exceptions)
• Patients who are never-smokers
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo +<br /><br>SoC chemotherapy as measured by DFS in MRD+ patients </p><br>
- Secondary Outcome Measures
Name Time Method <p>- To assess the efficacy of durvalumab plus SoC chemotherapy compared to<br /><br>placebo plus SoC chemotherapy as measured by DFS in all patients<br /><br>- To assess the efficacy of durvalumab plus SoC chemotherapy compared to<br /><br>placebo plus SoC chemotherapy as measured by DFS in MRD+ patients and all<br /><br>patients<br /><br>- To assess the efficacy of durvalumab plus SoC chemotherapy compared to<br /><br>placebo plus SoC chemotherapy as measured by OS in MRD+ patients and in all<br /><br>patients<br /><br>- To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients<br /><br>treated with durvalumab plus SoC chemotherapy compared to placebo plus SoC<br /><br>chemotherapy</p><br>