Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations - AVANZAR
Study identifier:D926NC00001
ClinicalTrials.gov identifier:NCT05687266
EudraCT identifier:2021-004606-21
CTIS identifier:N/A
Recruiting
Official Title
A Phase III, Randomised, Open-label, Multicentre, Global Study of Datopotamab Deruxtecan (Dato-DXd) in Combination With Durvalumab and Carboplatin Versus Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic NSCLC Without Actionable Genomic Alterations (D926NC00001; AVANZAR)
Medical condition
NSCLC
Phase
Phase 3
Healthy volunteers
No
Study drug
Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin, Pemetrexed, Paclitaxel
Sex
All
Estimated Enrollment
1280
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 29 Dec 2022
Estimated Primary Completion Date: 22 Feb 2027
Estimated Study Completion Date: 22 Feb 2027
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: Dato-DXd + Durvalumab + Carboplatin Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 1120 mg durvalumab plus carboplatin area under the curve [AUC] 5 mg/mL/minute. | Drug: Datopotamab deruxtecan Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Other Name: Dato-DXd Drug: Durvalumab Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle. Other Name: MEDI4736, Imfinzi Drug: Carboplatin Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
| Active Comparator: Histologic-specific therapy Non-squamous NSCLC participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m2 pemetrexed plus either AUC 5 mg/mL/minute carboplatin or 75 mg/m2 cisplatin. Squamous NSCLC participants will be randomized to receive 200 mg of pembrolizumab plus 200 mg/m2 paclitaxel plus AUC 5 or 6 mg/mL/minute carboplatin. | Drug: Carboplatin Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. Drug: Pembrolizumab Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first). Drug: Cisplatin Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. Drug: Pemetrexed Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle. Drug: Paclitaxel Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles. |
Contacts
Investigators
Principal Investigator
Charu Aggarwal
Perelman Center for Advanced Medicine
