PhIBT-DXd &Durvalumab Combo w/Cisplatin Carboplatin or Pemetrexed Tx of Pts w/Adv orMet NSCLC &HER2+

UCI Specialty Area: Cancer

Principal Investigator: Misako Nagasaka

Official Title: A Phase Ib Multicenter, Open-label Study to Evaluate the Safety and Tolerability of Trastuzumab Deruxtecan (T-DXd) and Immunotherapy Agents With and Without Chemotherapy Agents 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 (HER2) Overexpression (OE) (DESTINY-Lung03)

A Study On:

Lung

Study Description

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.

Eligibility

Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC (non-small cell lung cancer)
Part 1: Progression after 1 or 2 lines of systemic therapy for recurrent or metastatic setting.
Part 2: Treatment-naïve for non curative treatment for locally advanced or metastatic NSCLC.
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
HER2+ (IHC 3+ or IHC 2+) status as determined by central review of tumor tissue
WHO / ECOG performance status of 0 or 1
Measurable target disease assessed by the investigator using RECIST 1.1
Has protocol defined adequate organ and bone marrow function

HER2 mutation if previously known
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-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder and prior pneumonectomy
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 (Concentrated Ascites Reinfusion Therapy)
Unresolved toxicities from previous anticancer therapy OR prior discontinuation of any planned study therapy due to toxicity.

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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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