Real-Life Study With Nivolumab (BMS-936558) in Advanced NSCLC Patients After Prior Chemotherapy

NCT02910999 | Completed

• 1 other identifier: CA209-580
• Study Type: observational
• Target: 868
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to describe the real-life effectiveness and safety of nivolumab in advanced NSCLC patients in Germany, as well as the patient profile, pattern of use and the quality of life.

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Approximately 5 years

Secondary Outcomes (13)

• Progression-Free Survival (PFS)

  Approximately 5 years

• Overall Response Rate (ORR)

  Approximately 5 years

• Best Overall Response Rate (BORR)

  Approximately 5 years

• Best Overall Response (BOR)

  Approximately 5 years

• Duration of Response (DOR)

  Approximately 5 years

Study Arms (2)

NSCLC patients with squamous tumor histology

NSCLC patients with non-squamous tumor histology

Eligibility Criteria

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

Study Population

Both cohorts will be recruited in different sites. Office-based as well as outpatient units in clinics.

You may qualify if:

• Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC, Stage IIIB/Stage IV
• Decision to initiate a treatment with Nivolumab for the first time already undertaken by physician
• Males and Females, ≥18 years of age

You may not qualify if:

• Current primary diagnosis of a cancer other than advanced NSCLC. Example: A cancer other than NSCLC that requires systemic or other treatment.
• Pre-treatment with Nivolumab and/or Ipilimumab (pre-treatment with checkpoint-inhibitors other than Nivolumab and Ipilimumab, and Tyrosine Kinase Inhibitors(TKIs) is allowed)
• Current participation in an interventional clinical trial for treatment of NSCLC. (Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival can be enrolled. For blinded studies, the treatment administered needs to be known)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Frankfurt, 60590, Germany

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 22, 2016
• Study Start: August 9, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 13, 2024

Record last verified: 2024-05

Locations

DE (1)