Study Summary
This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
Eligible Conditions
- Non-Small Cell Lung Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 10 Secondary · Reporting Duration: Approximately 4 years
Approximately 3 Years
Progression-Free Survival (PFS) in the TROP2 biomarker positive population
Approximately 3 years
PFS in the Intent-to-Treat (ITT) population
PFS in the TROP2 biomarker negative population
PFS in the TROP2 biomarker positive and ITT populations
Approximately 4 years
Anti-Drug Antibody (ADA) for Dato-DXd
Duration of Response (DoR) in the TROP2 biomarker positive and ITT populations
OS in the ITT population
OS in the TROP2 biomarker negative population
Objective Response Rate (ORR) in the TROP2 biomarker positive and ITT populations
Overall Survival (OS) in the TROP2 biomarker positive population
Pharmacokinetics of Dato-DXd when combined with durvalumab and carboplatin.
Safety of Dato-DXd in combination with durvalumab and carboplatin
Time to Second Progression or Death (PFS2) in the TROP2 biomarker positive and ITT populations
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Histologic-specific therapy
1 of 2
Dato-DXd + Durvalumab + Carboplatin
1 of 2
Active Control
Experimental Treatment
1000 Total Participants · 2 Treatment Groups
Primary Treatment: Dato-DXd + Durvalumab + Carboplatin · No Placebo Group · Phase 3
Dato-DXd + Durvalumab + CarboplatinExperimental Group · 3 Interventions: Carboplatin, Datopotamab deruxtecan, Durvalumab · Intervention Types: Drug, Drug, Drug
Histologic-specific therapyActiveComparator Group · 5 Interventions: Pembrolizumab, Cisplatin, Carboplatin, Pemetrexed, Paclitaxel · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carboplatin
2014
Completed Phase 3
~7230
Durvalumab
2017
Completed Phase 2
~3220
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 4 years
Who is running the clinical trial?
AstraZenecaLead Sponsor
3,988 Previous Clinical Trials
91,856,618 Total Patients Enrolled
Charu AggarwalStudy ChairPerelman Center for Advanced Medicine
Eligibility Criteria
Age 18 - 130 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have NSCLC that is Stage IIIB, IIIC or IV and has not been treated with chemotherapy or any other systemic therapy.
You do not possess tumour tissue mutations in EGFR, ALK or ROS1, nor any actionable genomic alterations in NTRK, BRAF, RET, MET or other oncogenes with approved therapies.
You have had a tumour sample taken prior to signing the consent form.
You have sufficient bone marrow and organ capability within a week preceding randomisation.
You have not had another form of cancer in the last three years, and that cancer is considered to be at low risk for recurrence.
You have a combination of small-cell lung cancer and non-small cell lung cancer, with the sarcomatoid variant present in your NSCLC.
You have not yet recovered from any residual toxicities caused by prior anti-cancer treatment to Grade 1 or less than your pre-treatment state (with exceptions).
You have a history of autoimmune, connective tissue or inflammatory disorders (unless otherwise stated).
You are 18 or older at the time of screening.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments