About the study

DESTINY-Lung03 will investigate the safety and tolerability of trastuzumab deruxtecan in combination with durvalumab and chemotherapy in patients with HER2 positive advanced and metastatic non-small cell lung cancer. The efficacy will be also analyzed as a secondary endpoint.

Who can take part?

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

Inclusion criteria

1. Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC
2. Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.
3. Part 2: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.
4. Part 2: Patients must have tumors that lack activating EGFR mutations, EML4-ALK fusion or other targetable alterations. Prior adjuvant, neoadjuvant therapies are permitted if progression has occurred > 12 months from the end of last therapy
5. HER2+ (IHC 3+ or IHC 2+) status as determined by central review of tumor tissue
6. WHO / ECOG performance status of 0 or 1
7. Measurable target disease assessed by the investigator using RECIST 1.1
8. Has protocol defined adequate organ and bone marrow function

Exclusion criteria

1. HER2 mutation if previously known
2. Has a 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
3. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy
4. Active primary immunodeficiency known HIV infection, or active hepatitis B or C infection
5. Active infection including tuberculosis and uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
6. Spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms
7. Medical history of myocardial infarction within 6 months before treatment assignment, symptomatic CHF (New York Heart Association Class II to IV), clinically important cardiac arrhythmias, or a recent (< 6 months) cardiovascular event including stroke
8. A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or CART (Concentrated Ascites Reinfusion Therapy)
9. Unresolved toxicities from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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

How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.