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

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Non-small Cell Lung Cancer (NSCLC)

Treatments: Biological: Nivolumab + ipilimumab + platinum-based chemotherapy; Biological: Nivolumab + ipilimumab; Biological: Immuno-oncology-based therapy (excluding nivolumab-based regimens) with chemotherapy; Biological: Other dual-immuno-oncology therapy with chemotherapy

Study type: Observational

Funder types: Industry

Identifiers

NCT07215962

CA209-1542

Details and patient eligibility

About

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

300 participants in 4 patient groups

Cohort 1

Description:

Participants receiving nivolumab + ipilimumab treatment

Treatment:

Biological: Nivolumab + ipilimumab

Cohort 2

Description:

Participants receiving nivolumab + ipilimumab + platinum-based chemotherapy

Treatment:

Biological: Nivolumab + ipilimumab + platinum-based chemotherapy

Cohort 3

Description:

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

Treatment:

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

Cohort 4

Description:

Participants receiving other dual-IO with chemotherapy

Treatment:

Biological: Other dual-immuno-oncology therapy with chemotherapy