Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating nivolumab with chemotherapy for early-stage lung cancer 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

Run by Bristol-Myers Squibb · NCT06169956 · Data updated 2026-11-12

This study is testing whether combining nivolumab with chemotherapy can improve treatment outcomes for people in Germany with early-stage lung cancer that can be surgically removed.

More Non-Small Cell Lung Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionsnivolumab, chemotherapy
Locations1 site (Kempten (Allgäu), Bavaria)
StatusRecruiting
StartedNovember 30, 2023
Main results expectedSeptember 30, 2030
Study endsSeptember 30, 2030
Registry record updatedApril 18, 2024
Trial IDNCT06169956 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older diagnosed with non-metastatic non-small cell lung cancer and a PD-L1 expression level of 1% or more.

Probably not a fit

Patients with other primary cancers requiring treatment or contraindications as per the product characteristics may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather and analyze real-world data on the effectiveness of neoadjuvant nivolumab combined with platinum-based chemotherapy in patients with early-stage, resectable non-small cell lung cancer (NSCLC) in Germany. Participants will be monitored for their treatment outcomes and patient-reported outcomes as they undergo this combination therapy. The study focuses on patients who have a specific level of PD-L1 expression in their tumors, which is crucial for determining eligibility for this treatment approach.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of nivolumab combined with chemotherapy, potentially improving treatment outcomes for patients with early-stage lung cancer.

How similar studies have gone: Other studies have shown promising results with similar approaches using nivolumab in lung cancer treatment, indicating potential for success in this observational study.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Klinikverbund Allgaeu
    Kempten (Allgäu), Bavaria, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.