An Observational Study to Evaluate Neoadjuvant Nivolumab (OPDIVO®) in Combination With Platinum-Based Chemotherapy in Non-Metastatic Non-Small Cell Lung Cancer Participants in Germany

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Resectable Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Signed written informed consent Other criteria according to current Summary of product characteristics Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy<br> | Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy<br>* Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pathologic complete response (pCR) rate |  | Up to 5 years | 
| Rate of major pathologic response (MPR) |  | Up to 5 years | 
| Rate of partial pathologic response (pPR) |  | Up to 5 years | 
| Rate of pathologic non-responder |  | Up to 5 years | 
| Rate of tumor response | Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) | Up to 5 years | 
| Participant age |  | Baseline | 
| Participant sex |  | Baseline | 
| Participant insurance status |  | Baseline | 
| Participant employment status |  | Baseline | 
| Participant height in cm |  | Baseline | 
| Participant weight in kg |  | Baseline | 
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | ECOG-PS score of 0 = Fully active, able to carry on all pre-disease performance without restriction. ECOG-PS score of 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. ECOPG-PS score of 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours. ECOG-PS score of 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours. ECOG-PS score of 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. ECOG-PS score of 5 = Dead | Baseline and up to 5 years | 
| Participant medical history |  | Baseline | 
| Participant history of smoking |  | Baseline | 
| Participant concomitant treatments |  | Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years | 
| Participant subsequent treatments |  | Up to 5 years | 
| Date of initial diagnosis of NSCLC |  | Baseline | 
| Primary tumor assessed by histology subtype |  | Baseline | 
| Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA) |  | Baseline | 
| Location of primary tumor |  | Baseline | 
| Date of local relapse |  | Baseline to end of study, up to 5 years | 
| Location of metastases |  | Baseline to end of study, up to 5 years | 
| 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 | 
| 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 | 
| Number of participants with abnormal hematology results |  | Up to 5 years | 
| Number of participants with abnormal clinical chemistry results |  | Up to 5 years | 
| Number of participants with abnormal biomarker results |  | Baseline to end of study, up to 5 years | 
| Type of surgery |  | Up to 5 years | 
| Completeness of resection assessed by residual tumor classification | R0: no residual tumor, R1: microscopic residual tumor, R2: macroscopic residual tumor, Rx: unknown | Up to 5 years | 
| Number of participants with tumor resection |  | Up to 5 years | 
| Extend of resection (R0/R1/R2) |  | Up to 5 years | 
| Number of lymph nodes resected |  | Up to 5 years | 
| Surgical approach | Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery [VATS], robotic-assisted thoracic surgery [RATS]), minimal invasive to thoracotomy (conversion) | 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 | 
| Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 |  | 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 | EQ-5D-3L summary index: 1 represents perfect health, 0 represents death, negative values represent health states considered worse than death | Up to 5 years | 
| Time to next treatment | Time between end of primary treatment (neoadjuvant treatment + surgery + if needed by physician's assessment adjuvant therapy) to start of next treatment) | Up to 5 years | 
| Dosing of nivolumab |  | Up to 5 years | 
| Treatment regimens |  | Up to 5 years |