For Healthcare Professionals

A Single Arm Phase 2 Study to Evaluate Efficacy and Safety of Trastuzumab Deruxtecan for Patients With HER2 Mutant NSCLC


About the study

The purpose of this study is to evaluate the efficacy and safety of T-DXd in participants with HER2 mutant metastatic non-squamous NSCLC.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Pathologically documented metastatic non-squamous NSCLC.
  2. Has relapsed from or is refractory to at least one-line of anticancer treatment.
  3. Documented HER2 exon 19 or 20 mutation from central FFPE tumour tissue testing.
  4. WHO or ECOG performance status of 0 or 1.
  5. Presence of at least one measurable lesion assessed by the investigator based on RECIST 1.1.
  6. LVEF ≥ 50% within 28 days before enrolment.


Exclusion Criteria:

  1. Mixed small cell lung cancer, squamous histology NSCLC, and sarcomatoid histology variant NSCLC.
  2. Corrected QT interval (QTcF) prolongation to > 470 ms (females) or > 450 ms (males), based on average of the screening triplicate 12-lead ECG.
  3. History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (excluding alopecia) not yet resolved to Grade ≤1 or baseline. Participants with clinically stable chronic Grade 2 toxicity not reasonably expected to be exacerbated by study intervention may be included only after consultation with the AstraZeneca study physician or designee.
  5. Has been previously treated with HER2-targeted therapies, except for pan-HER class TKIs or has received prior treatment with an ADC which consists of an exatecan derivative that is a topoisomerase I inhibitor.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


HER2-mutant Non-Small Cell Lung Cancer

Age (in years)



Phase 2

Participants needed


Est. Completion Date

Jun 24, 2024

Treatment type



AstraZeneca identifier


Study number


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