A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Metastatic Squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung02)
Phase 3 trial tests new drug combo for advanced squamous lung cancer
Plain English Summary
A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) is a Phase 3 clinical trial sponsored by AstraZeneca studying Non-small Cell Lung Cancer. This study tests if a new drug called rilvegostomig, when given with chemotherapy, is better than pembrolizumab (another immunotherapy drug) plus chemotherapy for treating advanced squamous non-small cell lung cancer. It is for patients with metastatic squamous non-small cell lung cancer that has spread and whose tumors have a specific marker (PD-L1) that can be detected by a test. Participants will be randomly assigned to receive either rilvegostomig or pembrolizumab, both combined with chemotherapy. The treatment is given through an IV. Standard treatment options for this condition include chemotherapy alone or chemotherapy combined with immunotherapy like pembrolizumab. The trial aims to enroll 880 participants.
Official 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients with a confirmed diagnosis of squamous non-small cell lung cancer that has spread and cannot be cured by surgery or radiation. Tumors must have a PD-L1 expression level of 1% or higher, confirmed by a tissue test. Patients must not have received any prior treatment for advanced lung cancer, including chemotherapy, immunotherapy, or other targeted therapies. Individuals with brain metastases must have stable, asymptomatic disease and not require steroids or anti-seizure medication for at least 7 days before starting the study. This trial is studying Non-small Cell Lung Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study will measure how long patients live (overall survival) and how long they live without their cancer getting worse (progression-free survival) to see if the new combination treatment is more e The specific primary outcome measures are: Overall survival (OS) (Up to approximately 5 years); Progression-free survival (PFS) (Up to approximately 5 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial is important because it aims to find a more effective first-line treatment for patients with advanced squamous non-small cell lung cancer, addressing a need for better options in this speci As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-small Cell Lung Cancer, where improved treatment options are needed.
Investor Insight
This trial is testing a novel combination therapy for a significant cancer type, indicating potential for a new treatment option if successful, which could impact the market for lung cancer therapies. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage. The large enrollment target of 880 participants suggests significant investment in this program.
Is This Trial Right for Me?
Ask your doctor if your tumor has the PD-L1 marker and what your options are if you don't qualify for this trial. Participation involves regular clinic visits for IV infusions, blood tests, scans, and monitoring for side effects over several years. Be prepared for potential side effects from chemotherapy and immunotherapy, and discuss any new or worsening symptoms with your medical team immediately. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: QUADRUPLE
- Enrollment: 880 participants
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 Outcomes
- Overall survival (OS) (Up to approximately 5 years)
- Progression-free survival (PFS) (Up to approximately 5 years)
Secondary Outcomes
- Landmark overall survival (OS) rates (Up to approximately 5 years)
- Landmark progression-free survival (PFS) rates (Up to approximately 5 years)
- Time to second progression or death (PFS2) (Up to approximately 5 years)
- Overall response rate (ORR) (Up to approximately 5 years)
- Duration of response (DoR) (Up to approximately 5 years)
Full Eligibility Criteria
Inclusion Criteria: * 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. 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 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.
Trial Locations
- Research Site, Tucson, Arizona, United States
- Research Site, Springdale, Arkansas, United States
- Research Site, Anaheim, California, United States
- Research Site, Beverly Hills, California, United States
- Research Site, Loma Linda, California, United States
- Research Site, Los Alamitos, California, United States
- Research Site, Redlands, California, United States
- Research Site, San Francisco, California, United States
- Research Site, Walnut Creek, California, United States
- Research Site, West Haven, Connecticut, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06692738?
NCT06692738 is a Phase 3 INTERVENTIONAL study titled "A Global Phase III Study of Rilvegostomig or Pembrolizumab Plus Chemotherapy for First-Line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (NSCLC)." It is currently recruiting and is sponsored by AstraZeneca. The trial targets enrollment of 880 participants.
What conditions does NCT06692738 study?
This trial investigates treatments for Non-small Cell Lung Cancer. The primary condition under study is Non-small Cell Lung Cancer.
What treatments are being tested in NCT06692738?
The interventions being studied include: Rilvegostomig (DRUG), Pembrolizumab (DRUG), Carboplatin (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG). Administered intravenously (IV) on Day 1 of each 21-day cycle
What does Phase 3 mean for NCT06692738?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06692738?
This trial is currently "Recruiting." It started on 2024-11-18. The estimated completion date is 2029-10-08.
Who is sponsoring NCT06692738?
NCT06692738 is sponsored by AstraZeneca. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06692738?
The trial aims to enroll 880 participants. The trial is currently recruiting and accepting new participants.
How is NCT06692738 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs quadruple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06692738?
The primary outcome measures are: Overall survival (OS) (Up to approximately 5 years); Progression-free survival (PFS) (Up to approximately 5 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06692738 being conducted?
This trial is being conducted at 20 sites, including Tucson, Arizona; Springdale, Arkansas; Anaheim, California; Beverly Hills, California and 16 more sites (United States).
Where can I find official information about NCT06692738?
The official record for NCT06692738 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06692738. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06692738 testing in simple terms?
This study tests if a new drug called rilvegostomig, when given with chemotherapy, is better than pembrolizumab (another immunotherapy drug) plus chemotherapy for treating advanced squamous non-small cell lung cancer. It is for patients with metastatic squamous non-small cell lung cancer that has spread and whose tumors have a specific marker (PD-L1) that can be detected by a test.
Why is this trial significant?
This trial is important because it aims to find a more effective first-line treatment for patients with advanced squamous non-small cell lung cancer, addressing a need for better options in this speci As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06692738?
Common side effects of chemotherapy can include fatigue, nausea, hair loss, and a weakened immune system. Immunotherapy drugs like pembrolizumab and rilvegostomig can cause immune-related side effects, affecting various organs such as the lungs, skin, and digestive system. There is a risk of allergic reactions to the study drugs, and close monitoring is essential. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06692738?
Ask your doctor if your tumor has the PD-L1 marker and what your options are if you don't qualify for this trial. Participation involves regular clinic visits for IV infusions, blood tests, scans, and monitoring for side effects over several years. Be prepared for potential side effects from chemotherapy and immunotherapy, and discuss any new or worsening symptoms with your medical team immediately. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06692738 signal from an investment perspective?
This trial is testing a novel combination therapy for a significant cancer type, indicating potential for a new treatment option if successful, which could impact the market for lung cancer therapies. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will be randomly assigned to receive either rilvegostomig or pembrolizumab, both combined with chemotherapy. The treatment is given through an IV. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.