NCT06692738 · AstraZeneca
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)
What this study is about
The purpose of ARTEMIDE-Lung02 is to assess the effectiveness 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).
View original scientific description
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).
Interventions
DRUG
Rilvegostomig
Administered intravenously (IV) on Day 1 of each 21-day cycle
DRUG
Pembrolizumab
Administered intravenously (IV) on Day 1 of each 21-day cycle
DRUG
Carboplatin
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
DRUG
Paclitaxel
Administered intravenously (IV) on Day 1 of each 21-day cycle up to 4 cycles
DRUG
Nab-paclitaxel
Administered intravenously (IV) on Days 1, 8, and 15 of each 21-day cycle up to 4 cycles
Primary outcome measures
Overall survival (OS)
Time frame: 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)
Time frame: 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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Tucson, Arizona
- Springdale, Arkansas
- Anaheim, California
- Beverly Hills, California
- Loma Linda, California
- Los Alamitos, California
- Redlands, California
- San Francisco, California
- Walnut Creek, California
- West Haven, Connecticut
- Newark, Delaware
- Bay Pines, Florida
And 60 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 18, 2026 · Source of record for eligibility and locations