Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy for Non-Metastatic NSCLC: A German, Nationwide, Prospective, Observational, Multicenter Study in Patients Scheduled to Receive 3 Cycles Nivolumab in Combination With Platinum-Based Chemotherapy for Non-Metastatic (Stage and PD-L1 Expression According to Label) Non-Small Cell Lung Cancer

简要总结

主要结局

次要结局

• Date of local relapse(Baseline to end of study, up to 5 years)
• Rate of major pathologic response (MPR)(Up to 5 years)
• Participant age(Baseline)
• Participant sex(Baseline)
• Rate of pathologic non-responder(Up to 5 years)
• Pathologic complete response (pCR) rate(Up to 5 years)
• Rate of partial pathologic response (pPR)(Up to 5 years)
• Rate of tumor response(Up to 5 years)
• Participant insurance status(Baseline)
• Participant employment status(Baseline)
• Participant history of smoking(Baseline)
• Participant concomitant treatments(Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years)
• Participant height in cm(Baseline)
• Participant medical history(Baseline)
• Primary tumor assessed by histology subtype(Baseline)
• Number of participants with abnormal hematology results(Up to 5 years)
• Completeness of resection assessed by residual tumor classification(Up to 5 years)
• Number of participants with tumor resection(Up to 5 years)
• Extend of resection (R0/R1/R2)(Up to 5 years)
• Participant weight in kg(Baseline)
• Eastern Cooperative Oncology Group Performance Status (ECOG-PS)(Baseline and up to 5 years)
• Participant subsequent treatments(Up to 5 years)
• Date of initial diagnosis of NSCLC(Baseline)
• Location of metastases(Baseline to end of study, up to 5 years)
• Number of participants with abnormal clinical chemistry results(Up to 5 years)
• Type of surgery(Up to 5 years)
• Surgical approach(Up to 5 years)
• Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0(Up to 5 years)
• Dosing of nivolumab(Up to 5 years)
• Treatment regimens(Up to 5 years)
• Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)(Baseline)
• Location of primary tumor(Baseline)
• Date of metastatic diagnosis(Baseline to end of study, up to 5 years)
• Tumor size assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)(Up to 5 years)
• Number of participants with abnormal biomarker results(Baseline to end of study, up to 5 years)
• Number of lymph nodes resected(Up to 5 years)
• Tumor location assessed by medical imaging using x-rays, computed tomography (CT), magnetic resonance imaging (MRI), ultrasound, bone scintigraphy, positron emission tomography-computed tomography (PET- CT)(Up to 5 years)
• Length of hospital stay following surgery(From surgery to discharge from hospital, assessed up to 5 years)
• Incidence of adverse events(Up to 5 years)
• Patient-reported health-related Quality of Life assessed by using the validated European Quality of Life 5 Dimension 3 Level (EQ-5D-3L) questionnaire(Up to 5 years)
• Time to next treatment(Up to 5 years)