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) (D967YC00001) - DESTINY-Lung03

Astra Zeneca0 个研究点目标入组 4 人开始时间: 待定最近更新: 2024年4月9日

试验速览

暂无简介。

•- Histologically documented stage III locally advanced/metastatic and
•unresectable non-squamous NSCLC not amenable to curative surgery or radiation
•and/or stage IV NSCLC
•- Part 1 (dose-escalation combinations and T-DXd monotherapy): Patients with
•therapy-targetable alterations are allowed.
•- Part 2 (dose-expansion): Tumors that lack activating EGFR mutations or
•EML4-ALK fusion
•- Part 1 (dose-escalation combinations and T-DXd monotherapy): Progression on
•or after either one or 2 lines of therapy which is required to have included
•prior appropriate targeted therapy for patients with therapy-targetable
•alterations.
•- Part 2 (dose-expansion): treatment-naïve for locally advanced or mNSCLC.
•Prior adjuvant, neo adjuvant therapies are permitted if progression has
•occurred > 12 months from the end of last therapy
•- HER2+ (IHC 3+ or 2+) status as determined by central review of tumor tissue
•- WHO / ECOG performance status of 0 or 1
•- Has a measurable target disease assessed by the investigator using RECIST 1.1
•- Has a protocol defined adequate organ and bone marrow functions

•- 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
•- Lung criteria:
•* Specific intercurrent clinically significant illnesses including, but not
•limited to, any underlying pulmonary disorder
•* Any auto-immune, connective tissue or inflammatory disorders (eg. Rheumatoid
•arthritis, Sjogren*s syndrome, sarcoidosis etc) where this is documented, or a
•suspicion of pulmonary involvement at the time of screening.
•* Prior pneumonectomy (complete)
•- Active primary immunodeficiency known HIV infection, or active hepatitis B or
•C infection
•- Active infection including tuberculosis and uncontrolled infection requiring
•IV antibiotics, antivirals, or antifungals
•- 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
•- 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
•- A pleural effusion, ascites or pericardial effusion that requires drainage,
•peritoneal shunt, or CART

发起方

Astra Zeneca