A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06692738
- Lead Sponsor
- AstraZeneca
- 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 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 metastatic non-small cell lung cancer (mNSCLC) whose tumors express PD-L1 (tumor cells (TC) ≥ 1%).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 880
- Histologically or cytologically documented squamous NSCLC.
- Stage 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 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.
- 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 therapy received for advanced or mNSCLC.
- 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 treatment with steroids or other immunosuppressive treatment.
- Active primary immunodeficiency/active infectious disease(s).
- Active tuberculosis infection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Rilvegostomig Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig Arm A Paclitaxel Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig Arm A Nab-paclitaxel Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig Arm B Pembrolizumab Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab Arm B Carboplatin Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab Arm B Paclitaxel Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab Arm B Nab-paclitaxel Pembrolizumab in combination with carboplatin and paclitaxel or nab-paclitaxel followed by pembrolizumab Arm A Carboplatin Rilvegostomig in combination with carboplatin and paclitaxel or nab-paclitaxel followed by rilvegostomig
- Primary Outcome Measures
Name Time Method Overall survival (OS) Up to approximately 5 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 5 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 Outcome Measures
Name Time Method Landmark overall survival (OS) rates Up to approximately 5 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 5 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 5 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 5 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 5 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 5 years Concentration of rilvegostomig in serum.
Immunogenicity of rilvegostomig Up to approximately 5 years Presence of antidrug antibodies (ADAs), titer, and neutralizing antibodies for rilvegostomig.
Patient-reported physical functioning Up to approximately 5 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 5 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 5 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.
Trial Locations
- Locations (1)
Research Site
🇻🇳Vinh, Vietnam