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Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

NCT05687266 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1350

Last updated 2026-04-22

No results posted yet for this 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).

Conditions

Interventions

DRUG

Datopotamab deruxtecan

Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

DRUG

Durvalumab

Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

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.

Sponsors & Collaborators

Principal Investigators

  • Charu Aggarwal · Perelman Center for Advanced Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2027-11-01
Completion
2027-11-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Brazil
  • Bulgaria
  • Canada
  • China
  • France
  • Germany
  • Greece
  • Hungary
  • India
  • Italy
  • Japan
  • Mexico
  • Peru
  • Poland
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom
  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687266 on ClinicalTrials.gov