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T-DXd

Phase 1

Locally Advanced or Metastatic Non-Small Cell Lung Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 13, 2026

Target and mechanism

ModalitySmall molecule

Also known as T- Dxd

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment304

FDA Designations

No designations recorded

Clinical trial landscape

T-DXd · 1 trial · 1 indication

Phase 1 1
NCT04686305Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLCLocally Advanced or Metastatic Non-Small Cell Lung Cancer
RECRUITING304 Analytics
PHASE1RECRUITING
Phase Ib Study of the Safety of T-DXd and Immunotherapy Agents With and Without Chemotherapy in Advanced or Metastatic HER2+, Non-squamous NSCLC
Locally Advanced or Metastatic Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Frequency of AEs and SAEs
Safety and tolerability (and to determine RP2D) will be assessed for approximately 20 months from informed consent

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

Secondary Endpoints

Confirmed Objective Response Rate (ORR)
An average of approximately 12 months
Duration of Response (DoR)
An average of approximately 20 months
Disease Control Rate (DCR)
An average of approximately 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1A: T-DXd, Durvalumab and CisplatinEXPERIMENTALT-DXd, Durvalumab and Cisplatin
Arm 1B: T-DXd, Durvalumab and CarboplatinEXPERIMENTALT-DXd, Durvalumab and Carboplatin
Arm 1C: T-DXd, Durvalumab and PemetrexedEXPERIMENTALT-DXd, Durvalumab and Pemetrexed (Arm not initiated)
Arm 1D: T-DXdEXPERIMENTALT-DXd
Arm 3A: T-DXd and VolrustomigEXPERIMENTALDrug: T-DXd and Volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig
Arm 3B: T-DXd, Volrustomig and CarboplatinEXPERIMENTALDrug: T-DXd, Volrustomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion Other Name: Volrustomig Drug: Carboplatin Carboplatin: administered as an IV infusion
Arm 4A: T-DXd and RilvegostomigEXPERIMENTALT-DXd and Rilvegostomig Drug: T-DXd, Rilvegostomig T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936
Arm 4B T-DXd and Rilvegostomig with CarboplatinEXPERIMENTALDrug: T-DXd, Rilvegostomig and Carboplatin T-DXd: administered as an IV infusion Other Name: DS-8201a, Trastuzumab deruxtecan Biological/Vaccine: Rilvegostomig Rilvegostomig: administered as an IV infusion Other Name: Rilvegostomig, AZD2936 Drug: Carboplatin Carboplatin: administered as an IV infusion
Arm 5A: T-DXd and VolrustomigEXPERIMENTALDrug: T-DXd and volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion (priming dose in first cycle, fixed dose in subsequent cycles) Other Name: volrustomig
Arm 5B: T-DXd and VolrustomigEXPERIMENTALDrug: T-DXd and volrustomig T-DXd: administered as an IV infusion Other Name: DS-8201a, trastuzumab deruxtecan Biological/Vaccine: Volrustomig Volrustomig: administered as an IV infusion (fixed dose from first cycle onward) Other Name: volrustomig

Interventions

NameTypeDescription
T-DXdDRUGT-DXd: administered as an IV infusion
DurvalumabBIOLOGICALDurvalumab: administered as an IV infusion
CisplatinDRUGCisplatin: administered as an IV infusion
CarboplatinDRUGCarboplatin: administered as an IV infusion
PemetrexedDRUGPemetrexed: administered as an IV infusion (drug not used)
VolrustomigDRUGVolrustomig: administered as an IV infusion
RilvegostomigDRUGRilvegostomig: administered as an IV infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites91

Inclusion criteria: * Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC * Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting. * Part 3, Part 4 and Part 5: Patients must have tumors that do not harbor known genomic alter...

Countries:United StatesAustraliaBelgiumBrazilCanadaChinaFranceIsraelItalyMalaysiaNetherlandsPhilippinesPolandSingaporeSouth KoreaSpainTaiwanThailandTurkey (Türkiye)
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Frequently asked questions about T-DXd

What is T-DXd used for in Locally Advanced or Metastatic Non-Small Cell Lung Cancer?

T-DXd is being studied for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC). It is an investigational therapy in Phase 1 clinical development, meaning it has not yet been approved for this indication. The drug is being evaluated in a clinical trial to assess its safety and potential efficacy.

What does T-DXd target?

T-DXd targets HER2, a protein that can be present on the surface of cancer cells. The drug is designed to bind to HER2-positive tumors, which are a subset of non-small cell lung cancer cases. This targeting mechanism is the basis for its potential activity against HER2-expressing cancers.

Who makes T-DXd?

T-DXd is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca is conducting clinical trials to evaluate the safety and efficacy of T-DXd in patients with locally advanced or metastatic non-small cell lung cancer.

What phase is T-DXd in?

T-DXd is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities for the treatment of non-small cell lung cancer. The ongoing Phase 1 trial is designed to evaluate the safety and tolerability of T-DXd in combination with other agents.

What clinical trials is T-DXd in?

T-DXd is being studied in a Phase 1 clinical trial with the identifier NCT04686305. This trial is 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.' The trial is currently recruiting participants and has an enrollment target of 304 patients.

Is T-DXd the same as T-Dxd?

Yes, T-DXd and T-Dxd refer to the same investigational drug. The name T-DXd is the primary designation, while T-Dxd is an alternative spelling. Both names are used to describe the same therapy being developed by AstraZeneca for the treatment of locally advanced or metastatic non-small cell lung cancer.