Clinical trial NCT06169956: 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
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Resectable Non-small Cell Lung Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-12-14
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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%

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


Eligibility criteria: 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

Primary outcomes:
measure: Event-free survival
timeFrame: Up to 5 years
Secondary outcomes:
measure: Pathologic complete response (pCR) rate
timeFrame: Up to 5 years
measure: Rate of major pathologic response (MPR)
timeFrame: Up to 5 years
measure: Rate of partial pathologic response (pPR)
timeFrame: Up to 5 years
measure: Rate of pathologic non-responder
timeFrame: Up to 5 years
measure: Rate of tumor response
timeFrame: Up to 5 years
measure: Participant age
timeFrame: Baseline
measure: Participant sex
timeFrame: Baseline
measure: Participant insurance status
timeFrame: Baseline
measure: Participant employment status
timeFrame: Baseline
measure: Participant height in cm
timeFrame: Baseline
measure: Participant weight in kg
timeFrame: Baseline
measure: Eastern Cooperative Oncology Group Performance Status (ECOG-PS)
timeFrame: Baseline and up to 5 years
measure: Participant medical history
timeFrame: Baseline
measure: Participant history of smoking
timeFrame: Baseline
measure: Participant concomitant treatments
timeFrame: Baseline and during neoadjuvant nivolumab plus platinum-based chemotherapy, up to 5 years
measure: Participant subsequent treatments
timeFrame: Up to 5 years
measure: Date of initial diagnosis of NSCLC
timeFrame: Baseline
measure: Primary tumor assessed by histology subtype
timeFrame: Baseline
measure: Tumor stage assessed by tumor node metastasis (TNM; stage IB-IIIA)
timeFrame: Baseline
measure: Location of primary tumor
timeFrame: Baseline
measure: Date of local relapse
timeFrame: Baseline to end of study, up to 5 years
measure: Location of metastases
timeFrame: Baseline to end of study, up to 5 years
measure: Date of metastatic diagnosis
timeFrame: Baseline to end of study, up to 5 years
measure: 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)
timeFrame: Up to 5 years
measure: 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)
timeFrame: Up to 5 years
measure: Number of participants with abnormal hematology results
timeFrame: Up to 5 years
measure: Number of participants with abnormal clinical chemistry results
timeFrame: Up to 5 years
measure: Number of participants with abnormal biomarker results
timeFrame: Baseline to end of study, up to 5 years
measure: Type of surgery
timeFrame: Up to 5 years
measure: Completeness of resection assessed by residual tumor classification
timeFrame: Up to 5 years
measure: Number of participants with tumor resection
timeFrame: Up to 5 years
measure: Extend of resection (R0/R1/R2)
timeFrame: Up to 5 years
measure: Number of lymph nodes resected
timeFrame: Up to 5 years
measure: Surgical approach
timeFrame: Up to 5 years
measure: Length of hospital stay following surgery
timeFrame: From surgery to discharge from hospital, assessed up to 5 years
measure: Incidence of adverse events
timeFrame: Up to 5 years
measure: Severity of adverse events graded by Common Terminology Criteria for Adverse Events (CTCAE) V5.0
timeFrame: Up to 5 years
measure: Patient-reported health-related Quality of Life assessed by using the validated European Quality of Life 5 Dimension 3 Level (EQ-5D-3L) questionnaire
timeFrame: Up to 5 years
measure: Time to next treatment
timeFrame: Up to 5 years
measure: Dosing of nivolumab
timeFrame: Up to 5 years
measure: Treatment regimens
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Kempten
country: Germany
facility: Klinikverbund Allgaeu
state: Bayern
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: