Last updated 22 days ago
A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations
450 patients around the world
Available in Brazil, Mexico
Eligible participants will be those diagnosed with unresectable, locally advanced or
metastatic histologically documented non-squamous NSCLC with HER2 exons 19 or 20
mutations and who are treatment-naïve for palliative intent systemic therapy for locally
advanced or metastatic disease.
The study aims to evaluate the efficacy, safety and tolerability of trastuzumab
deruxtecan as first-line treatment of Non-Small Cell Lung Cancer (NSCLC) as compared with
Standard of Care treatment (Investigator's choice of cisplatin or carboplatin +
pembrolizumab + pemetrexed). This study aims to see if trastuzumab deruxtecan allows
patients to live longer without the cancer getting worse or simply to live longer,
compared to patients receiving standard of care treatment. This study is also looking to
see how the treatment and the cancer affects patients' quality of life.
AstraZeneca
450Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
To 123 Years
All Gender
Medical requirements
- Participants at least 18 years of age.Locally advanced and unresectable NSCLC, not amenable to curative therapy, or metastatic disease.Histologically documented non-squamous NSCLC with HER2 mutation in exons 19 or 20 by tissue NGS or ctDNA.Treatment-naïve for palliative intent systemic therapy for locally advanced or metastatic disease.Left ventricular ejection fraction (LVEF) ≥ 50%.Measurable disease assessed by Investigator based on RECIST 1.1.Protocol-defined adequate organ function including cardiac, renal, hepatic function.ECOG 0-1.Having tumour tissue available for central testing.
- Tumors with targetable alterations to EGFR (or other targetable mutations including but not limited to ALK, if routinely tested as a targetable alteration with approved available therapy).Any untreated brain metastases, including asymptomatic or clinically inactive brain metastases.Active autoimmune or inflammatory disorders.Medical history of myocardial infarction within 6 months prior to randomization.History of non-infectious pneumonitis/ILD, current or suspected ILD.Lung-specific intercurrent clinical significant severe illness.Contraindication to platinum-based doublet chemotherapy or pembrolizumab.
StudyDESTINY-Lung04
SponsorAstraZeneca
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
To 123 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05048797
