ClinTrial Refer

Trial Acronym
CA224-1093

Registration Number
NCT06561386

Scientific Title
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 of 1% to 49%

The purpose of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy to Pembrolizumab with Chemotherapy in participants with stage IV or recurrent Non-squamous Non-small Cell Lung Cancer with PD-L1 1-49%.

Inclusion Criteria

Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory
Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria.
Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening.
Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease.

Exclusion Criteria

Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations.
Participants must not have untreated central nervous system (CNS) metastases.
Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization.
Participants must not have an active autoimmune disease.
Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids.
Participants must not have a history of myocarditis, regardless of etiology.
Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways.
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial Location Name

Address

Status

Fiona Stanley Hospital (Oncology)

11 Robin Warren Dr, Murdoch WA 6150, Australia

Recruiting

Primary Contact : Caroline Stone, caroline.stone@health.wa.gov.au , (08) 6152 6530

Secondary Contact : Edwin Tan, Edwin.tan@health.wa.gov.au , 61861526720

Gallipoli Medical Research (Greenslopes Private Hospital)

Lower Lobby Level Administration Building Greenslopes Private Hospital, Newdegate St, Greenslopes QLD 4120, Australia

Recruiting

Primary Contact : Vanessa Irvine, IrvineV@ramsayhealth.com.au , 07 3394 7807

Secondary Contact : Sashika Naidoo, enquiries.GMR@gallipoliresearch.org.au , 07 3394 7284

Bristol-Myers Squibb

Website URL

Link Name

Link URL

N/A

Secondary IDs
N/A

Study Type
Interventional

Intervention Code
Treatment - Drugs

Phase
Phase 3

Minimum Age
18

Maximum Age
99

Date Registered
03/09/2024

Date Closed
N/A

Status
Open

Enrolment Type
By Specialist and/or Surgeon Referral

Mutation Status and Biomarker
N/A

Is it a Cohort Trial?
No

Is this a Tele-Trial?
No

Can healthy volunteer participate?
No

Discipline

Health Condition

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