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 (NENI)

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

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 Overview

• Status: Recruiting
• Conditions: Resectable Non-small Cell Lung Cancer
• Intervention / Treatment: Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• Germany
  • Bayern
    • Kempten, Bayern, Germany, 87439
      • Recruiting
      • Klinikverbund Allgaeu
      • Contact: Christian Schumann, Site 0001; Phone Number: +8315302382

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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%

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Event-free survival	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events		Up to 5 years
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)		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
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2023
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: November 17, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-1210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No