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
Study Type
OBSERVATIONAL
Enrollment
400
Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics
Klinikverbund Allgaeu
Kempten (Allgäu), Bavaria, Germany
RECRUITINGEvent-free survival
Time frame: Up to 5 years
Pathologic complete response (pCR) rate
Time frame: Up to 5 years
Rate of major pathologic response (MPR)
Time frame: Up to 5 years
Rate of partial pathologic response (pPR)
Time frame: Up to 5 years
Rate of pathologic non-responder
Time frame: Up to 5 years
Rate of tumor response
Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)
Time frame: Up to 5 years
Participant age
Time frame: Baseline
Participant sex
Time frame: Baseline
Participant insurance status
Time frame: Baseline
Participant employment status
Time frame: Baseline
Participant height in cm
Time frame: Baseline
Participant weight in kg
Time frame: Baseline
First line of the email MUST contain NCT # and Site #.
CONTACT
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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
Time frame: Baseline and up to 5 years
Participant medical history
Time frame: Baseline
Participant history of smoking
Time frame: Baseline
Participant concomitant treatments
Time frame: Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years
Participant subsequent treatments
Time frame: Up to 5 years
Date of initial diagnosis of NSCLC
Time frame: Baseline
Primary tumor assessed by histology subtype
Time frame: Baseline
Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)
Time frame: Baseline
Location of primary tumor
Time frame: Baseline
Date of local relapse
Time frame: Baseline to end of study, up to 5 years
Location of metastases
Time frame: Baseline to end of study, up to 5 years
Date of metastatic diagnosis
Time frame: 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)
Time frame: 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)
Time frame: Up to 5 years
Number of participants with abnormal hematology results
Time frame: Up to 5 years
Number of participants with abnormal clinical chemistry results
Time frame: Up to 5 years
Number of participants with abnormal biomarker results
Time frame: Baseline to end of study, up to 5 years
Type of surgery
Time frame: 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
Time frame: Up to 5 years
Number of participants with tumor resection
Time frame: Up to 5 years
Extend of resection (R0/R1/R2)
Time frame: Up to 5 years
Number of lymph nodes resected
Time frame: Up to 5 years
Surgical approach
Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery \[VATS\], robotic-assisted thoracic surgery \[RATS\]), minimal invasive to thoracotomy (conversion)
Time frame: Up to 5 years
Length of hospital stay following surgery
Time frame: From surgery to discharge from hospital, assessed up to 5 years
Incidence of adverse events
Time frame: Up to 5 years
Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
Time frame: 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
Time frame: 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)
Time frame: Up to 5 years
Dosing of nivolumab
Time frame: Up to 5 years
Treatment regimens
Time frame: Up to 5 years