Phase Ib Study of the Safety of T-DXd and Durvalumab With Chemotherapy in Advanced or Metastatic HER2+ Non-squamous NSCLC (DL03)

  • STATUS
    Recruiting
  • End date
    Feb 12, 2024
  • participants needed
    136
  • sponsor
    AstraZeneca
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Updated on 29 May 2022
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Summary

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.

Description

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)

Details
Condition Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Treatment cisplatin, carboplatin, Pemetrexed, durvalumab, Trastuzumab deruxtecan
Clinical Study IdentifierNCT04686305
SponsorAstraZeneca
Last Modified on29 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Histologically documented unresectable locally advanced/metastatic non-squamous NSCLC
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

Exclusion Criteria

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
HER2 mutation if previously known
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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