Clinical trial for Non-Small Cell Lung Cancer
Official title Phase III, Open-label, Study of First-line Dato-DXd in Combination With Rilvegostomig for Advanced Non-squamous NSCLC With High PD-L1 Expression (TC ≥ 50%) and Without Actionable Genomic Alterations
ClinicalTrials.gov ID: NCT06357533
What this study is testing
What is Datopotamab Deruxtecan?
An investigational intravenous antibody‑drug conjugate being studied as a potential first‑line treatment for advanced non‑small cell lung cancer with high PD‑L1 expression. It is designed to bind to the TROP2 protein on cancer cells and deliver a chemotherapy payload that interferes with DNA replication.
Also referred to as Dato-DXd.
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 study aims to find out how well the drug combo works and how safe it is compared with standard pembrolizumab treatment.
- Who it's for
- Adults with locally advanced or metastatic non‑squamous lung cancer, high PD‑L1 (≥50%) and no targetable genetic changes.
- What's involved
- Participants will receive either Dato-DXd with rilvegostomig, rilvegostomig alone, or pembrolizumab, plus regular clinic visits and safety tests.
- 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 non-squamous NSCLC.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive...
- Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic...
- Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
- Known tumour PD-L1 expression status defined as TC ≥ 50%
You likely can't join if
- Prior systemic therapy for advanced/metastatic NSCLC.
- Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
- History of another primary malignancy within 3 years
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies...
- Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
See the full eligibility criteria
- Histologically or cytologically documented non-squamous NSCLC.
- Stage IIIB or IIIC or Stage IV metastatic NSCLC (according to Edition 8 of the AJCC staging manual) not amenable to curative surgery or definitive chemoradiation.
- Absence of sensitising EGFR mutations, and ALK and ROS1 rearrangements, and absence of documented local test result for any other known genomic alteration for which there are locally approved and available targeted...
- Must provide tumor sample to determine PD-L1 status, TROP2 status and other biomarkers.
- Known tumour PD-L1 expression status defined as TC ≥ 50%
- At least one lesion, not previously irradiated that qualifies as a RECIST 1.1 target lesion at baseline
- ECOG performance status of 0 or 1
- Adequate bone marrow reserve and organ function
- Prior systemic therapy for advanced/metastatic NSCLC.
- Squamous cell histology, or predominantly squamous cell histology NSCLC; mixed small cell lung cancer; NSCLC histology, sarcomatoid variant.
- History of another primary malignancy within 3 years
- Active or prior documented autoimmune or inflammatory disorders (with exceptions)
- Any evidence of severe or uncontrolled disease that makes it undesirable for the participant to participate in the study or that would jeopardies compliance with the protocol.
- Has clinically significant third-space fluid retention (for example pleural effusion) and is not amenable for repeated drainage.
- History of any ILD/pneumonitis, including radiation pneumonitis (apart from radiation pneumonitis that did not require steroids), or drug-induced ILD/pneumonitis, has current or suspected ILD/pneumonitis that cannot be...
- Has significant pulmonary function compromise, as determined by the investigator
- Spinal cord compression, or brain metastases unless participant treated and no longer symptomatic, radiologically stable, and who require no treatment with corticosteroids or anticonvulsants.
- History of leptomeningeal carcinomatosis
- Known clinically significant corneal disease
- Active infection with TB, HBV, HCV, Hepatitis A, or known HIV infection that is not well controlled
- History of active primary immunodeficiency
The study team makes the final eligibility decision.
Where it is enrolling
- Anchorage, Alaska, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Springdale, Arkansas, United States
- Anaheim, California, United States
- Beverly Hills, California, United States
- Fountain Valley, California, United States
- Clermont, Florida, United States
- Gainesville, Florida, United States
- Miami Beach, Florida, United States
- Orange City, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Hinsdale, Illinois, United States
- Noblesville, Indiana, United States
- Paducah, Kentucky, United States
- Annapolis, Maryland, United States
- Boston, Massachusetts, United States
- Dearborn, Michigan, United States
+ 182 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, but 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?
This study is enrolling now at Anchorage, Alaska, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Springdale, Arkansas, United States; Anaheim, California, United States; Beverly Hills, California, United States and 196 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.