About this trial
The purpose of this observational study is to collect and evaluate real-world data to assess the effectiveness of neoadjuvant nivolumab when given in combination with platinum-based chemotherapy in participants with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Diagnosis of non-metastatic non-small cell lung cancer with tumor Programmed death-ligand 1 (PD-L1) expression level of 1% or more (tumor proportion score (TPS); according to label approved in the European Union)
Decision to initiate a neoadjuvant treatment with nivolumab plus platinum-based chemotherapy for treatment of non-small cell lung cancer according to current Summary of product characteristics and independent of the study
Willing to complete patient-reported outcome questionnaires and sufficient understanding of the German language
Disqualifiers
Current primary diagnosis of cancer other than non-small cell lung cancer that requires systemic or other treatment
Other contraindications according to current Summary of product characteristics
Trial population
Adult participants aged ≥ 18 years of age or older who are diagnosed with resectable non-small cell lung cancer at high risk of recurrence and whose tumors have programmed death-ligand 1 (PD-L1) expression ≥ 1%
Trial design
Cohort
Prospective
Treatments tested in this trial
Neoadjuvant nivolumab in combination with platinum-based chemotherapy
DrugNeoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics
Treatment groups
Trial outcomes
Primary outcomes
Event-free survival
Secondary outcomes
Pathologic complete response (pCR) rate
Rate of major pathologic response (MPR)
Rate of partial pathologic response (pPR)
Rate of pathologic non-responder
Sponsors and contacts
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