Long-Term Safety Outcomes and First-Line Treatment Patterns in Patients With Non-Small Cell Lung Cancer and Programmed Death-1 (Pd-L1) <1%

NCT07215962 | Active Not Recruiting FDA Drug

• 1 other identifier: CA209-1542
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the treatment-related adverse events and associated healthcare resource use in programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy

Conditions

Non-small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (6)

• Incidence of treatment-related adverse events

  Baseline

• Participant baseline clinical characteristics

  Baseline

• Time to onset of treatment-related adverse events

  Up to 8 years

• Number of treatment-related adverse events resolved

  Up to 8 years

• Number of participants receiving treatment for treatment-related adverse events by drug class

  Up to 8 years

• Number of participants that discontinued immune-oncology therapy due to treatment-related adverse events

  Up to 8 years

Secondary Outcomes (1)

• Healthcare Resource Utilization (HCRU) associated with treatment-related adverse event

  Up to 8 years

Study Arms (4)

Cohort 1

Participants receiving nivolumab + ipilimumab treatment

Biological: Nivolumab + ipilimumab

Cohort 2

Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy

Biological: Nivolumab + ipilimumab + platinum-based chemotherapy

Cohort 3

Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment

Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy

Cohort 4

Participants receiving other dual-IO with chemotherapy

Biological: Other dual-immuno-oncology therapy with chemotherapy

Interventions

Nivolumab + ipilimumab BIOLOGICAL

According to the product label

Cohort 1

Nivolumab + ipilimumab + platinum-based chemotherapy BIOLOGICAL

According to the product label

Cohort 2

Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy BIOLOGICAL

According to the product label

Cohort 3

Other dual-immuno-oncology therapy with chemotherapy BIOLOGICAL

According to the product label

Cohort 4

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 comprise of programmed death ligand 1 (PD-L1) negative individuals diagnosed with advanced/metastatic non-small cell lung cancer (NSCLC) who received first-line therapy in routine clinical practice at the Florida Cancer Specialists and Research Institute

You may qualify if:

• Are ≥ 18 years of age at the index date
• Have a confirmed diagnosis of advanced/metastatic non-small cell lung cancer (NSCLC) (stage IIIB-IV) (squamous and non-squamous)
• Have PD-L1\< 1% level as reported
• Received one of the following 1L treatments:
• Cohort 1: nivolumab + ipilimumab
• Cohort 2: nivolumab + ipilimumab + platinum-based chemotherapy
• Cohort 3: Immuno-oncology (IO)-based therapy (excluding nivolumab-based regimens) with chemotherapy
• Cohort 4: Dual-IO with chemotherapy (eg. tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + \[carboplatin or cisplatin\] + gemcitabine, tremelimumab-actl + durvalumab + carboplatin + albumin-bound paclitaxel, tremelimumab-actl + durvalumab + \[carboplatin or cisplatin\] + pemetrexed)
• Have ≥ 6 months of documented post-index (follow-up) period after the index date - Participants who die within 6 months of follow-up will be included

You may not qualify if:

• Have positive or unknown EGFR or ALK mutation before the index date
• Have a gap of \> 120 days between metastatic NSCLC diagnosis and index date
• Were included in a clinical trial for 1L therapy
• Enter a hospice within 6 months of the follow-up will be excluded
• Have other concurrent primary cancer diagnoses

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Florida Cancer Specialists & Research Institute

Fleming Island, Florida, 32003, 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; Platinum Compounds; Drug Therapy

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; Inorganic Chemicals; Therapeutics

Study Officials

• Bristol Myers 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: October 9, 2025
• First Posted: October 14, 2025
• Study Start: November 22, 2024
• Primary Completion: July 1, 2025
• Study Completion: March 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)