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

Active, not recruiting

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Biological: Nivolumab + ipilimumab; Biological: Nivolumab + ipilimumab + platinum-based chemotherapy; Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy; Biological: Other dual-immuno-oncology therapy with chemotherapy

• Registration Number: NCT07215962
• Lead Sponsor: Bristol-Myers Squibb

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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-22
• Primary Completion: 2025-07-01
• Status Verified: 2025-10
• Study First Submitted: 2025-10-09
• Study First Submitted QC: 2025-10-09
• Last Update Submitted: 2025-10-09
• Study First Posted: 2025-10-14
• Last Update Posted: 2025-10-14
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Inclusion Criteria:

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 1	Nivolumab + ipilimumab	Participants receiving nivolumab + ipilimumab treatment
Cohort 2	Nivolumab + ipilimumab + platinum-based chemotherapy	Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy
Cohort 3	Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy	Participants receiving immuno-oncology therapy (excl nivolumab) with chemotherapy treatment
Cohort 4	Other dual-immuno-oncology therapy with chemotherapy	Participants receiving other dual-IO with chemotherapy

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-related adverse events	Baseline
Time to onset of treatment-related adverse events	Up to 8 years
Number of treatment-related adverse events resolved	Up to 8 years
Participant baseline clinical characteristics	Baseline
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 Outcome Measures

Name	Time	Method
Healthcare Resource Utilization (HCRU) associated with treatment-related adverse event	Up to 8 years

Trial Locations

Locations (1)

Florida Cancer Specialists & Research Institute; 🇺🇸 Fleming Island, Florida, United States