This phase I study is investigating how safe, tolerable and effective targeted therapy (trastuzumab deruxtecan) is alone, and in combination with immunotherapy (durvalumab) and chemotherapy (cisplatin, carboplatin or pemetrexed) in people with HER2-positive, advanced or metastatic, non-small cell lung cancer.
This trial is treating patients with non-small cell lung cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- Your cancer has not spread to other parts of the body.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
Use the hyperlinks, where available to access additional clinical trial information.
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)
This study will consist of two parts. Part 1 is a dose-escalation study design allowing the assessment of safety, tolerability and recommended dose levels of the combination of trastuzumab deruxtecan (T-DXd) and durvalumab plus cisplatin, carboplatin or pemetrexed. Part 1 will involve people on their second or third-line of treatment. In Part 2, expansions in the treatment naïve setting on any recommended dose level may take place to study preliminary efficacy as well. In Part 1, the dose of T-DXd and the chemotherapeutic components on Arms 1A, 1B and 1C (cisplatin, carboplatin or pemetrexed) will be modified during the dose-escalation part in order to find the recommended phase 2 dose (RP2D). The dose of durvalumab will remain fixed in this part of the study. Arm 1D will ass T-DXd as monotherapy. All treatments will be administered via an intravenous (IV) infusion. The Part 2 of the study may be initiated following Part 1, at the discretion of the sponsor.
Recruiting Hospitals Read More