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New treatment option for Carcinoma, Non-Small Cell Lung
Official title A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06868277
What this study is testing
What is Rilvegostomig?
Rilvegostomig is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, non-small cell lung.
Also referred to as AZD2936.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements...
- Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes...
- WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2...
You likely can't join if
- As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or...
- 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...
- 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.
See the full eligibility 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)...
- 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...
- Adequate organ and bone marrow function
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- La Mesa, California, United States
- Los Alamitos, California, United States
- Farmington, Connecticut, United States
- Newark, Delaware, United States
- Bay Pines, Florida, United States
- Clearwater, Florida, United States
- St. Petersburg, Florida, United States
- Marietta, Georgia, United States
- Chicago, Illinois, United States
- Decatur, Illinois, United States
- Des Moines, Iowa, United States
- Waterloo, Iowa, United States
- Leawood, Kansas, United States
- Lexington, Kentucky, United States
- Owensboro, Kentucky, United States
- Bethesda, Maryland, United States
- Frederick, Maryland, United States
- Silver Spring, Maryland, United States
- Towson, Maryland, United States
- Saginaw, Michigan, United States
+ 228 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Mesa, California, United States; Los Alamitos, California, United States; Farmington, Connecticut, United States; Newark, Delaware, United States; Bay Pines, Florida, United States; Clearwater, Florida, United States and 242 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.