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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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Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

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