Long-term Outcomes Among Patients With Programmed Death-ligand 1 <1% Metastatic Non-small Cell Lung Cancer Treated With First-line Nivolumab + Ipilimumab + 2 Cycles of Chemotherapy

NCT07024862 | Active Not Recruiting FDA Drug

• 1 other identifier: CA209-1496
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The study will assess the long-term real-world outcomes among adults diagnosed with programmed death-ligand 1 (PD-L1) \<1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US

Conditions

Metastatic Non-small Cell Lung Cancer

Keywords

Metastatic non-small cell lung cancer

Outcome Measures

Primary Outcomes (16)

• Participant baseline socio-demographics

  Baseline

• Participant baseline clinical characteristics

  Baseline

• Participant treatment history

  Baseline

• Treatment start and stop dates

  Up to 6-months

• Reasons for 1L treatment selection

  Day 1

• Initial 1L NIC treatment dose received

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Day 1

• Type of chemotherapy received as part of NIC treatment

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Day 1

• Participant NIC treatment chemotherapy schedule

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Day 1

• Number of NIC treatment interruptions

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Up to 6-months

• Date(s) of NIC treatment interruptions

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Up to 6-months

• Reasons for NIC treatment interruptions

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Up to 6-months

• Length of NIC treatment delay/interruption

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Up to 6-months

• Reasons for NIC treatment discontinuation

  NIC = first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy

  Up to 6-months

• Type of 2L treatment received

  Up to 6-months

• Reasons for not initiating 2L treatment

  Up to 6-months

• Start and stop dates of 2L treatment initiation

  Up to 6-months

Study Arms (1)

Cohort 1

Adults diagnosed with programmed death-ligand 1 (PD-L1) \<1% metastatic non-small cell lung cancer (mNSCLC) treated with first-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC) in the US

Biological: nivolumab + ipilimumab

Interventions

nivolumab + ipilimumab BIOLOGICAL

First-line (1L) nivolumab + ipilimumab + 2 cycles of chemotherapy (NIC)

Cohort 1

Eligibility Criteria

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

Study Population

The study population will include adults diagnosed with programmed death-ligand 1 (PD-L1) \<1% metastatic non-small cell lung cancer (NSCLC) and treated with 1L combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) in the US community oncology setting

You may qualify if:

• At least 18 years old at confirmed diagnosis with metastatic non-small cell lung cancer (NSCLC) (stage IV), squamous or non-squamous histology
• Initiated first-line (1L) combination nivolumab, ipilimumab, and 2 cycles of platinum-doublet chemotherapy (NIC) regimen between 01 January 2018 and 2 years prior to study launch
• Tumor programmed death-ligand 1 (PD-L1) negative expression (i.e., PD-L1 \<1%)
• No EGFR, ALK, or ROS1 genetic mutation (i.e., wild type)
• Minimum of 6 months of follow-up after initiation of 1L NIC\*

You may not qualify if:

• Any prior systemic therapy for metastatic non-small cell lung cancer (NSCLC)

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Cardinal Health

Dublin, Ohio, 43017, United States

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol Myers Squibb Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: October 24, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)