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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neoadjuvant nivolumab in combination with platinum-based chemotherapy | Drug | Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics |
| Measure | Description | Time Frame |
|---|---|---|
| Event-free survival | Up to 5 years |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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%
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikverbund Allgaeu | Recruiting | Kempten (Allgäu) | Bavaria | 87439 | Germany |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| 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 |
| ID | Term |
|---|---|
| D017671 | Platinum Compounds |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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