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NCT Number: NCT07024862

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Metastatic Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardinal Health

Dublin, Ohio, 43017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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*

Exclusion criteria

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

Treatment and study plan

Nivolumab + ipilimumab

Biological

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

Primary outcomes

  1. Participant baseline socio-demographics

    Time frame: Baseline

  2. Participant baseline clinical characteristics

    Time frame: Baseline

  3. Participant treatment history

    Time frame: Baseline

  4. Treatment start and stop dates

    Time frame: Up to 6-months

  5. Reasons for 1L treatment selection

    Time frame: Day 1

  6. Initial 1L NIC treatment dose received

    Time frame: Day 1

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

  7. Type of chemotherapy received as part of NIC treatment

    Time frame: Day 1

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

  8. Participant NIC treatment chemotherapy schedule

    Time frame: Day 1

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

  9. Number of NIC treatment interruptions

    Time frame: Up to 6-months

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

  10. Date(s) of NIC treatment interruptions

    Time frame: Up to 6-months

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

  11. Reasons for NIC treatment interruptions

    Time frame: Up to 6-months

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

  12. Length of NIC treatment delay/interruption

    Time frame: Up to 6-months

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

  13. Reasons for NIC treatment discontinuation

    Time frame: Up to 6-months

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

  14. Type of 2L treatment received

    Time frame: Up to 6-months

  15. Reasons for not initiating 2L treatment

    Time frame: Up to 6-months

  16. Start and stop dates of 2L treatment initiation

    Time frame: Up to 6-months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Long-Term Real-World Outcomes Among Patients 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)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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