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

NCT06169956 | Recruiting FDA Drug

• 1 other identifier: CA209-1210
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 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

Conditions

Resectable Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Up to 5 years

Secondary Outcomes (41)

• 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

  Up to 5 years

Study Arms (1)

Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy

Drug: Neoadjuvant nivolumab in combination with platinum-based chemotherapy

Interventions

Neoadjuvant nivolumab in combination with platinum-based chemotherapy DRUG

Neoadjuvant treatment of resectable non-small cell lung cancer with nivolumab in combination with chemotherapy according to current summary of product characteristics

Participants receiving neoadjuvant nivolumab in combination with platinum-based chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Klinikverbund Allgaeu

Kempten (Allgäu), Bavaria, 87439, Germany

RECRUITING

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

Platinum Compounds

Intervention Hierarchy (Ancestors)

Inorganic Chemicals

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 14, 2023
• Study Start: November 30, 2023
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)