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A Study of Dato-DXd in Combination With Durvalumab and Carboplatin for First-line Treatment of Advanced NSCLC Without Actionable Genomic Alterations
EU CTIS ID: 2023-505993-14-00
What this study is testing
To demonstrate the superiority of Dato-DXd in combination with durvalumab and carboplatin relative to pembrolizumab in combination with platinum-based chemotherapy by assessment of the following: 1. PFS by BICR in first-line treatment of participants with non-squamous TROP2 biomarker positive locally-advanced or metastatic NSCLC 2. OS in first-line treatment of participants with non-squamous TROP2 biomarker positive locally-advanced or metastatic NSCLC 3. PFS by BICR in first-line treatment of participants with non-squamous locally-advanced or metastatic NSCLC 4. OS in first-line treatment of participants with non-squamous locally-advanced or metastatic NSCLC
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants ≥ 18 years at screening
- Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease
- Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations). Testing is not required for tumors with squamous histology, with exceptions.
- ECOG PS of 0 or 1
- Archival tumour tissue
- Has adequate bone marrow reserve and organ function within 7 days before randomization
You likely can't join if
- Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
- History of another primary malignancy with exceptions
- Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1 or baseline, with exceptions.
- Spinal cord compression or clinically or radiologically active brain metastases
- History of leptomeningeal carcinomatosis.
- Known active or uncontrolled hepatitis B or C virus infection.
See the full eligibility criteria
- Participants ≥ 18 years at screening
- Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease
- Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations). Testing is not required for tumors with squamous histology, with exceptions.
- ECOG PS of 0 or 1
- Archival tumour tissue
- Has adequate bone marrow reserve and organ function within 7 days before randomization
- Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC
- History of another primary malignancy with exceptions
- Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1 or baseline, with exceptions.
- Spinal cord compression or clinically or radiologically active brain metastases
- History of leptomeningeal carcinomatosis.
- Known active or uncontrolled hepatitis B or C virus infection.
- Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals.
- Clinically significant corneal disease
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
The study team makes the final eligibility decision.
Where it's taking place
- China
- Mexico
- Vietnam
- Canada
- United Kingdom
- Peru
- Korea, Republic of
- Taiwan
- United States
- Japan
- Turkey
- India
- Brazil
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Mexico; Vietnam; Canada; United Kingdom; Peru and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.