Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04686305 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 1
Development phase
244
Enrollment target
20
Study locations

NCT04686305: Recruiting Phase 1 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer, sponsored by AstraZeneca.

NCT04686305 is a Phase 1 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 244 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (307% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04686305, a Phase 1 study of Locally Advanced or Metastatic Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 1
Development phase
244 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Occurrence of AEs and SAEs graded according to NCI CTCAE v5.0

Conditions Studied

Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Interventions

  • DRUG Carboplatin
  • DRUG Cisplatin
  • DRUG Pemetrexed
  • BIOLOGICAL Durvalumab
  • DRUG T-DXd

Study Locations (20)

Other

  • Research Site - Adelaide
  • Research Site - Heidelberg
  • Research Site - Nedlands
  • Research Site - Edegem
  • Research Site - Barretos
  • Research Site - Porto Alegre
  • Research Site - São Paulo

California

  • Research Site - Duarte
  • Research Site - Newport Beach
  • Research Site - Orange
  • Research Site - Santa Rosa

New York

  • Research Site - Buffalo
  • Research Site - New York
  • Research Site - The Bronx

Kansas

  • Research Site - Westwood

Maryland

  • Research Site - Baltimore

Michigan

  • Research Site - Detroit

Texas

  • Research Site - Houston

Virginia

  • Research Site - Fairfax

Trial Details

FieldValue
Enrollment Target 244 participants
Start Date 2021-03-09
Est. Completion 2027-06-30
Phase Phase 1
AstraZeneca

1,285 total trials

What NCT04686305 shows while recruiting

NCT04686305 is an interventional study that assigns participants to a tested intervention. The registered 244 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (307% higher).

The record links to 1 condition, with Locally Advanced or Metastatic Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT04686305 names 20 study sites across 9 states, led by Other, California, New York.

Frequently Asked Questions

What is clinical trial NCT04686305 about?

NCT04686305 is a clinical study titled "Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC". 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.

What is the current status of trial NCT04686305?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 244 participants. The study started on 2021-03-09. Estimated completion is 2027-06-30.

What conditions does trial NCT04686305 study?

This clinical trial studies the following conditions: Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

What interventions are being tested in trial NCT04686305?

The interventions under investigation include: Carboplatin (DRUG), Cisplatin (DRUG), Pemetrexed (DRUG), Durvalumab (BIOLOGICAL), T-DXd (DRUG).

Who is sponsoring clinical trial NCT04686305?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04686305 being conducted?

This trial has 20 study locations across California, Kansas, Maryland, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04686305's enrollment target sits among peer trials

244 192nd of 2000 higher than 1,808 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT02227251 · 244 participants · Phase 2

    Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

  • NCT04317534 · 244 participants · Phase 2

    Adjuvant Pembrolizumab vs Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) With Primary Tumors Between 1-4 cm

  • NCT04683250 · 244 participants · Phase 1

    Study of RET Inhibitor TAS0953/HM06 in Patients With Advanced Solid Tumors With RET Gene Abnormalities

  • NCT05703269 · 244 participants · NA

    Comparing Single vs Multiple Dose Radiation for Cancer Patients With Brain Metastasis and Receiving Immunotherapy

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT04686305

Source: ClinicalTrials.gov NCT04686305, the US trial registry maintained by the National Library of Medicine. NCT04686305 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.