A Phase Ib Multicenter, Open-label Dose-escalation Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Durvalumab in Combination With Cisplatin, Carboplatin or Pemetrexed in First-line Treatment of Patients With Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC) and Human Epidermal Growth Factor Receptor 2 Overexpression (HER2+) (DESTINY-Lung03).
Principal Investigator
Dr. G. Ruiter
Drugs
Trastuzumab Deruxtecan (T-DXd) and Durvalumab in combination with Cisplatin, Carboplatin or Pemetrexed
Part 1 is a dose escalation study by design, allowing the assessment of safety, tolerability and recommended dose levels of the combination of T-DXd and durvalumab plus cisplatin, carboplatin or pemetrexed. In part 2, expansions in the treatment naïve setting on any recommended dose level may take place to study preliminary efficacy as well.
The target population of interest are patients with advanced or metastatic non-small cell lung cancer measurable disease by RECIST criteria, HER2 overexpression, ECOG PS of 0 to 1, patients who have received 1 or 2 prior therapies for recurrent or metastatic disease (Part 1) and patients who are treatment naïve for recurrent or metastatic disease (Part 2).
Read more on clinicaltrials.gov.
Tumor type: NSCLC, non small cell lung cancer, lung cancer
Tumor subtype: non-squamous, adenocarcinoma
Tumor characteristics: Her2 positive
Type of patients: first line
Additional comments
The study is currently closed and it will open again later this year.