Non-small Cell Lung Cancer
Conditions
Keywords
ARTEMIDE-Lung02, Rilvegostomig (AZD2936), Non-small cell lung cancer (NSCLC), Bi-specific antibody, T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain (TIGIT), Programmed death-ligand 1 (PD-L1), Pembrolizumab, Carboplatin, Paclitaxel, Nab-paclitaxel
Brief summary
The purpose of ARTEMIDE-Lung02 is to assess the efficacy and safety of rilvegostomig in combination with platinum-based chemotherapy for the first-line (1L) treatment of patients with locally advanced or metastatic squamous non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1).
Detailed description
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line (1L) treatment for patients with squamous locally advanced or metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
Interventions
DRUGRilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
DRUGPembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
DRUGCarboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
DRUGPaclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
DRUGNab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind masking
Intervention model description
Arm A: Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig Arm B: Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically documented squamous NSCLC. * Stage III B/C or IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment. * Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any actionable driver oncogenes for which there are locally approved and available targeted 1L therapies. * Provision of acceptable tumor sample to confirm tumor PD-L1 expression TC ≥ 1%. * At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL 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 or MRI and is suitable for accurate repeated measurements. * Adequate organ and bone marrow function.
Exclusion criteria
* Presence of small cell and neuroendocrine histology components. * Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization. * Any prior systemic, non-curative therapy received for NSCLC. * Any prior treatment with an anti-PD-1 or anti-PD-L1 agent. * Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms. * 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. * Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents or other immunosuppressive drugs. * Active primary immunodeficiency/active infectious disease(s). * Active tuberculosis infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to approximately 6 years | OS is defined as the time from randomization until the date of death due to any cause. |
| Progression-free survival (PFS) | Up to approximately 6 years | PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Landmark overall survival (OS) rates | Up to approximately 6 years | OS is defined as the time from randomization until the date of death due to any cause. |
| Landmark progression-free survival (PFS) rates | Up to approximately 6 years | PFS is defined as the time from randomization until radiological progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression). |
| Time to second progression or death (PFS2) | Up to approximately 6 years | PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial progression event), after the start of the first subsequent therapy, or death from any cause, whichever occurs first. The date of the second progression will be recorded by the investigator in the electronic Case Report Form (eCRF) and defined according to local standard clinical practice. |
| Overall response rate (ORR) | Up to approximately 6 years | ORR is defined as the proportion of participants who have a confirmed complete response (CR) or confirmed partial response (PR), by using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1). |
| Duration of response (DoR) | Up to approximately 6 years | DoR is defined as the time from the date of first documented response until the date of documented progression using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) or death due to any cause (in the absence of progression). |
| Pharmacokinetic (PK) of rilvegostomig | Up to approximately 6 years | Concentration of rilvegostomig in serum. |
| Immunogenicity of rilvegostomig | Up to approximately 6 years | Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig. |
| Patient-reported physical functioning | Up to approximately 6 years | Proportion of participants with maintained or improved physical functioning as measured by Patient-Reported Outcomes Measurement Information System Physical Function - Short Form 8c - 7 day (PROMIS PF-SF 8c - 7 day) at each time point. |
| Patient-reported global health status (GHS)/quality of life (QoL) | Up to approximately 6 years | Time to deterioration (TTD) of GHS/QoL as measured by the European Organization for Research and Treatment of Cancer Item Library 172 (EORTC IL172). TTD is defined as time from randomization to the date of first deterioration. Deterioration is defined as a worsening change from baseline that reaches a clinically meaningful change threshold. |
| Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) | Up to approximately 6 years | Time to deterioration (TTD) in pulmonary symptoms as measured by the Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ). TTD is defined as time from randomization to the date of first deterioration. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, France, Germany, Hungary, India, Italy, Japan, Malaysia, Netherlands, Peru, Poland, Puerto Rico, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States, Vietnam
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed