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
- Conditions
- Resectable Non-small Cell Lung Cancer
- Interventions
- Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy
- Registration Number
- NCT06169956
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy Neoadjuvant nivolumab in combination with platinum-based chemotherapy -
- Primary Outcome Measures
Name Time Method Event-free survival Up to 5 years
- Secondary Outcome Measures
Name Time Method Participant medical history Baseline Location of primary tumor Baseline 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 Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)
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 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 R0: no residual tumor, R1: microscopic residual tumor, R2: macroscopic residual tumor, Rx: unknown
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 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
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 Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery \[VATS\], robotic-assisted thoracic surgery \[RATS\]), minimal invasive to thoracotomy (conversion)
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 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 Date of local relapse Baseline to end of study, 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 EQ-5D-3L summary index: 1 represents perfect health, 0 represents death, negative values represent health states considered worse than death
Time to next treatment Up to 5 years Time between end of primary treatment (neoadjuvant treatment + surgery + if needed by physician's assessment adjuvant therapy) to start of next treatment)
Trial Locations
- Locations (1)
Klinikverbund Allgaeu
🇩🇪Kempten, Bayern, Germany