Evaluation of PD-L1 Expression Levels in Lung Cancer Samples from the ARTEMIDE-Lung04 Study

Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, France, Georgia, Germany, Greece, Ireland, Israel, Italy, Japan, Malaysia, Portugal, Romania, South Korea, Spain, Switzerland, Turkey (T�rkiye), United Kingdom, United States (ICTRP)

ID di studio ICTRP
NCT06868277 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Clinical Performance Study Protocol for Use of the VENTANA PD-L1 (SP263) CDx Assay: Evaluation of PD-L1 Expression Levels in Non-small Cell Lung Cancer Specimens from Phase III Study D702GC00001 (ARTEMIDE-Lung04) (BASEC)

Titolo accademico
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04) (ICTRP)

Titolo pubblico
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer (ICTRP)

Malattie studiate
Carcinoma, Non-Small Cell Lung (ICTRP)

Intervento studiato
Biological: RilvegostomigBiological: Pembrolizumab (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)

Criteri di inclusione/esclusione
Inclusion Criteria:

- Histologically or cytologically documented NSCLC (non small lung cancer), including
all histological subtypes.

- Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint
Committee on Cancer Edition 8) not amenable to curative treatment.

- Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic
lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result
is required for all non-squamous histology subtypes.

- Absence of documented tumor genomic mutation results from tests conducted as part of
standard local practice in any other actionable driver oncogenes for which there are
locally approved targeted 1L (first line) therapies.

- WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group)
performance status of 0 or 1, with no deterioration over the previous 2 weeks prior
to baseline at screening and prior to randomization.

- Minimum life expectancy of 12 weeks.

- Provision of acceptable tumor sample for the central testing prior to randomization.

- At least one lesion not previously irradiated that qualifies as a RECIST 1.1
(Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at
baseline and can be accurately measured at baseline as >= 10 mm in the longest
diameter (except lymph nodes, which must have short axis >= 15 mm) with CT (computed
tomography) or MRI (magnetic resonance imaging) and is suitable for accurate
repeated measurements.

- Adequate organ and bone marrow function

Exclusion Criteria:

- As judged by the investigator, any severe or uncontrolled systemic diseases, makes
it undesirable for the participant to participate in the study or that would
jeopardize compliance with the protocol.

- History of organ transplant.

- Active or prior documented autoimmune or inflammatory disorders requiring chronic
treatment with steroids or other immunosuppressive treatment.

- History of another primary malignancy except for malignancy treated with curative
intent with no known active disease >= 2 years before the first dose of study
intervention and of low potential risk for recurrence.

- Presence of small cell and neuroendocrine histology components.

- Brain metastases unless asymptomatic, stable, and not requiring steroids or
anticonvulsants for at least 4 weeks prior to start of study intervention.

- Active primary immunodeficiency/active infectious disease(s)

- Active tuberculosis infection

- Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small
cell lung cancer).

- Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor
tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy
targeting immune-regulatory receptors or mechanisms.

- Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or
anti-PD-L1 (anti-programmed death-ligand 1) agent. (ICTRP)

non disponibile

Endpoint primari e secondari
Overall Survival (OS);Progression-Free Survival (PFS) (ICTRP)

Landmark Overall Survival (OS) rates;Landmark Progression-Free Survival (PFS) rates;Objective Response Rate (ORR);Duration of Response (DoR);Time to second progression or death (PFS2);Pharmakokinetics (PK) of rilvegostomig;Immunogenicity of rilvegostomig;Patient-reported physical functioning;Patient-reported global health status (GHS)/quality of life (QoL);Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) (ICTRP)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
non disponibile

Contatti aggiuntivi
AstraZeneca Clinical Study Information Center, information.center@astrazeneca.com, 1-877-240-9479 (ICTRP)

ID secondari
2024-517780-24-00, D702GC00001 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT06868277 (ICTRP)