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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neoadjuvant nivolumab in combination with platinum-based chemotherapy.
- Who it may be relevant to
- Registry conditions: Resectable Non-small Cell Lung Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- 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
Primary outcome measures
- Event-free survival [Time frame: Up to 5 years]
Secondary outcome measures (12)
- Pathologic complete response (pCR) rate [Time frame: Up to 5 years]
- Rate of major pathologic response (MPR) [Time frame: Up to 5 years]
- Rate of partial pathologic response (pPR) [Time frame: Up to 5 years]
- Rate of pathologic non-responder [Time frame: Up to 5 years]
- Rate of tumor response [Time frame: Up to 5 years]
- Participant age [Time frame: Baseline]
- Participant sex [Time frame: Baseline]
- Participant insurance status [Time frame: Baseline]
- Participant employment status [Time frame: Baseline]
- Participant height in cm [Time frame: Baseline]
- Participant weight in kg [Time frame: Baseline]
- Eastern Cooperative Oncology Group Performance Status (ECOG-PS) [Time frame: Baseline and up to 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Klinikverbund Allgaeu — Kempten (Allgäu)
Identifiers
NCT: NCT06169956 · CA209-1210