Information sheet on the clinical study - FINN

Main indication

Non-small cell lung cancer

Study name (study type)

FINN (non-interventional study)

Study sponsor

BMS (Bristol-Myers Squibb GmbH & Co)

Registration number

ClinicalTrials.gov Identifier: NCT04794010

FOR RAPID READERS:

Study for patients with metastatic non-small cell lung cancer. Treatment data and questionnaires will be collected from the patients. This is an observational study and has no influence on the treatment method prescribed by the physician

DETAILED INFORMATION

Study Title

A Germany-wide prospective, multicenter observational study of first-line therapy with nivolumab and ipilimumab in combination with two cycles of chemotherapy in patients with metastatic non-small cell lung cancer 

Which conditions are being treated in the study?

Non-small cell lung cancer

Are specific subgroups of patients with one of the mentioned conditions being treated?

Patients with metastatic non-small cell lung cancer 

Background on the study medication

Nivolumab is an immunostimulatory and indirectly antitumor agent from the group of monoclonal antibodies that is used to treat various types of cancer. It binds to the PD-1 receptor on T cells and inhibits interaction with the ligands PD-L1 and PD-L2 on cancer cells. This stimulates the immune system.

Ipilimumab is an active substance from the group of monoclonal antibodies with indirect cytotoxic and antitumor properties. It enhances the T-cell-mediated immune response by binding to CTLA-4 (cancer immunotherapy)

Study Protocol.

Patients will be treated with nivolumab plus ipilimumab in combination with two cycles of chemotherapy for 5 years starting from the beginning of treatment. During this time, patients will come to the GPR Clinic regularly for examinations and interviews.

Inclusion criteria

• Patients diagnosed with stage IV NSCLC without known EGFR or ALK mutations. 
• Patients who are 18 years of age or older

Exclusion criteria

• Patients with known EGFR or ALK mutations
• Current primary diagnosis of a cancer other than NSCLC that requires systemic or other treatment

Your contacts: Investigators at the center and contact information

Prof. Dr. Dimitri Flieger

Email: flieger@~@gp-ruesselsheim.de

Phone: 06142 88-1456

Responsible staff members in the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032