Resectable Non-small Cell Lung Cancer
Conditions
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
Interventions
DRUGNeoadjuvant nivolumab in combination with platinum-based chemotherapy
Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival | Up to 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Up to 5 years | Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) |
| 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) | 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 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 | 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 | — |
| Number of lymph nodes resected | 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) |
| 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 | — |
| Pathologic complete response (pCR) rate | 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) |
| Dosing of nivolumab | Up to 5 years | — |
| Treatment regimens | Up to 5 years | — |
| Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0 | Up to 5 years | — |
Countries
Germany
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed