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Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC

NCT04686305 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2026-04-13

No results posted yet for this study

Summary

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with Immunotherapy Agents with and without chemotherapy in patients with HER2 over-expressing non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Conditions

Interventions

DRUG

T-DXd

T-DXd: administered as an IV infusion

BIOLOGICAL

Durvalumab

Durvalumab: administered as an IV infusion

DRUG

Cisplatin

Cisplatin: administered as an IV infusion

DRUG

Carboplatin

Carboplatin: administered as an IV infusion

DRUG

Pemetrexed

Pemetrexed: administered as an IV infusion (drug not used)

DRUG

Volrustomig

Volrustomig: administered as an IV infusion

DRUG

Rilvegostomig

Rilvegostomig: administered as an IV infusion

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-09
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • France
  • Israel
  • Italy
  • Malaysia
  • Netherlands
  • Philippines
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

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 NCT04686305 on ClinicalTrials.gov