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

Resectable Non-small Cell Lung Cancer Clinical Trial

— NENI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06169956
• Other study ID #: CA209-1210
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: September 30, 2030

Study information

• Verified date: April 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 30, 2030
• Est. primary completion date: September 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Resectable Non-small Cell Lung Cancer

Intervention

Drug:
• Neoadjuvant 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

Locations

Country	Name	City	State
Germany	Klinikverbund Allgaeu	Kempten	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival		Up to 5 years
Secondary	Pathologic complete response (pCR) rate		Up to 5 years
Secondary	Rate of major pathologic response (MPR)		Up to 5 years
Secondary	Rate of partial pathologic response (pPR)		Up to 5 years
Secondary	Rate of pathologic non-responder		Up to 5 years
Secondary	Rate of tumor response	Classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)	Up to 5 years
Secondary	Participant age		Baseline
Secondary	Participant sex		Baseline
Secondary	Participant insurance status		Baseline
Secondary	Participant employment status		Baseline
Secondary	Participant height in cm		Baseline
Secondary	Participant weight in kg		Baseline
Secondary	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
Secondary	Participant medical history		Baseline
Secondary	Participant history of smoking		Baseline
Secondary	Participant concomitant treatments		Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years
Secondary	Participant subsequent treatments		Up to 5 years
Secondary	Date of initial diagnosis of NSCLC		Baseline
Secondary	Primary tumor assessed by histology subtype		Baseline
Secondary	Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)		Baseline
Secondary	Location of primary tumor		Baseline
Secondary	Date of local relapse		Baseline to end of study, up to 5 years
Secondary	Location of metastases		Baseline to end of study, up to 5 years
Secondary	Date of metastatic diagnosis		Baseline to end of study, up to 5 years
Secondary	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
Secondary	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
Secondary	Number of participants with abnormal hematology results		Up to 5 years
Secondary	Number of participants with abnormal clinical chemistry results		Up to 5 years
Secondary	Number of participants with abnormal biomarker results		Baseline to end of study, up to 5 years
Secondary	Type of surgery		Up to 5 years
Secondary	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
Secondary	Number of participants with tumor resection		Up to 5 years
Secondary	Extend of resection (R0/R1/R2)		Up to 5 years
Secondary	Number of lymph nodes resected		Up to 5 years
Secondary	Surgical approach	Thoracotomy, minimal invasive (video-assisted thoracoscopic surgery [VATS], robotic-assisted thoracic surgery [RATS]), minimal invasive to thoracotomy (conversion)	Up to 5 years
Secondary	Length of hospital stay following surgery		From surgery to discharge from hospital, assessed up to 5 years
Secondary	Incidence of adverse events		Up to 5 years
Secondary	Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0		Up to 5 years
Secondary	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
Secondary	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
Secondary	Dosing of nivolumab		Up to 5 years
Secondary	Treatment regimens		Up to 5 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls