General information
  • Disease category Lung Cancer (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel, Bellinzona, Lausanne, Other
    (BASEC)
  • Contact Dr. Andreas Schmitt andreasmichael.schmitt@usb.ch (BASEC)
  • Data Source(s) BASEC: Import from 02.07.2025 ICTRP: N/A
  • Last update 02.07.2025 14:45
HumRes67042 | SNCTP000006466 | BASEC2025-00411

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy with Pembrolizumab Plus Chemotherapy in Patients with Non-Squamous, Non-Small Cell Lung Cancer Stage IV/Recurrence with PD-L1 Expression ≥ 1 %

  • Disease category Lung Cancer (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Basel, Bellinzona, Lausanne, Other
    (BASEC)
  • Contact Dr. Andreas Schmitt andreasmichael.schmitt@usb.ch (BASEC)
  • Data Source(s) BASEC: Import from 02.07.2025 ICTRP: N/A
  • Last update 02.07.2025 14:45

Summary description of the study

The aim of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy with Pembrolizumab in combination with chemotherapy in participants with non-squamous, non-small cell lung cancer in stage IV or recurrence with a PD-L1 expression of ≥ 1%.

(BASEC)

Intervention under investigation

Experimental Arm A:

Drug Nivolumab

Fixed dose on specified days

 

Drug Relatlimab

Fixed dose on specified days

 

Drug Carboplatin

Fixed dose on specified days

 

Drug Pemetrexed

Fixed dose on specified days

 

Drug Cisplatin

Fixed dose on specified days

 

 

Active Comparator: Arm B

 

Drug Pembrolizumab

Fixed dose on specified days

 

Drug: Carboplatin

Fixed dose on specified days

 

Drug Pemetrexed

Fixed dose on specified days

 

Drug Cisplatin

Fixed dose on specified days

(BASEC)

Disease under investigation

Non-Small Cell Lung Cancer

(BASEC)

Criteria for participation in trial
- Participants must have a histologically confirmed non-small cell lung cancer (NSCLC) in stage IV or recurrence with non-squamous histology, for which no prior systemic cancer therapy has been administered as primary treatment for advanced or metastatic disease. - Participants must have measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST v1.1 criteria. - Participants must have an ECOG performance status (Eastern Cooperative Oncology Group) of ≤ 1 at screening, which must be confirmed prior to randomization. - Participants must have a life expectancy of at least 3 months at the time of randomization. - Participants must have a measurable PD-L1 value of ≥ 1% tumor cells (TC) in the tested immunohistochemistry test VENTANA PD-L1 (SP263) CDx Assay for the detection of PD-L1 expression. This test is performed by a central laboratory during the screening prior to randomization. (BASEC)

Exclusion criteria
- Participants must not have untreated metastases in the central nervous system (CNS). - Participants must not have a concurrent malignancy requiring treatment. - Participants must not have an active autoimmune disease. - Participants must not have a history of interstitial lung disease or pneumonitis that requires oral or intravenous (IV) glucocorticoid treatment to support therapy. - Participants must not have a history of myocarditis. - Participants must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. - Additional inclusion and exclusion criteria defined in the study protocol apply. - Female participants must not be pregnant or breastfeeding. - Participants must not have leptomeningeal metastases (carcinomatous meningitis). (BASEC)

Trial sites

Basel, Bellinzona, Lausanne, Other

(BASEC)

Münsterlingen

(BASEC)

not available

Sponsor

Bristol-Myers Squibb SA, Steinhausen

(BASEC)

Contact

Contact Person Switzerland

Dr. Andreas Schmitt

+41612655074

andreasmichael.schmitt@usb.ch

Universitätsspital Basel

(BASEC)

Scientific Information

not available

Name of the authorising ethics committee (for multicentre studies, only the lead committee)

Ethics Committee northwest/central Switzerland EKNZ

(BASEC)

Date of authorisation

02.07.2025

(BASEC)


ICTRP Trial ID
not available

Official title (approved by ethics committee)
A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy as First-line Treatment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 Expression ≥ 1% (BASEC)

Academic title
not available

Public title
not available

Disease under investigation
not available

Intervention under investigation
not available

Type of trial
not available

Trial design
not available

Inclusion/Exclusion criteria
not available

not available

Primary and secondary end points
not available

not available

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
not available

Additional contacts
not available

Secondary trial IDs
not available

Results-Individual Participant Data (IPD)
not available

Further information on the trial
not available

Results of the trial

Results summary

not available

Link to the results in the primary register

not available