Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)

  • STATUS
    Recruiting
  • End date
    Sep 18, 2023
  • participants needed
    150
  • sponsor
    Daiichi Sankyo, Inc.
Updated on 18 July 2021
measurable disease
HER2
cancer chemotherapy
erbb2
liquid biopsy
platinum-based chemotherapy
lung carcinoma

Summary

This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one regimen of prior anticancer therapy (second line or later) that must have contained a platinum-based chemotherapy drug.

Description

This randomized, two-arm, phase 2, multicenter study will evaluate the safety and efficacy of 5.4 mg/kg and 6.4 mg/kg trastuzumab deruxtecan administered every 3 weeks (Q3W) in participants with HER2-mutated metastatic NSCLC. Each participant is expected to receive approximately 14 months of trastuzumab deruxtecan treatment. The primary endpoint of the study will be objective response rate (independent central review). Secondary endpoints will include, but not limited to, disease control rate, duration of response, progression-free survival, objective response rate (investigator), overall survival, and safety.

Details
Condition Non-Small Cell Lung Cancer, nsclc
Treatment Trastuzumab deruxtecan
Clinical Study IdentifierNCT04644237
SponsorDaiichi Sankyo, Inc.
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Written informed consent
Men or women 18 years, follow local regulatory requirements if the legal age of the consent for study participation is >18 years
Pathologically documented metastatic NSCLC with a known activating HER2 mutation. Note: A HER2 mutation documented only from a liquid biopsy samples cannot be used for enrollment
Had previous treatment (second line or later [2L+], including platinum therapy), not amenable to curative surgery or radiation
Presence of at least 1 measurable lesion confirmed by the blinded Independent Central Review based on RECIST version 1.1
Willing and able to provide an archival tumor tissue sample. A fresh biopsy is required if an archival tumor tissue sample cannot be supplied. Fine needle aspirates are not acceptable
Eastern Cooperative Oncology Group performance status 0 to 1
Left ventricular ejection fraction 50% within 28 days before randomization
Adequate organ function as specified in protocol within 14 days before randomization
Adequate treatment washout period before randomization
Participants of reproductive/childbearing potential agree to use a highly effective form of contraception (or avoid intercourse) during study period and up to 7 months (females) and 4 months (males) after last study dose
Males should not freeze or donate sperm throughout the study period up to at least 4 months after last study dose; females should not donate or retrieve ova for their own use throughout the study period and up to at least 7 months after last study dose
Life expectancy 3 months or more

Exclusion Criteria

Known driver mutation in the epidermal growth factor receptor (EGFR) or BRAF gene or a known anaplastic lymphoma kinase (ALK) or ROS1 fusion
Medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Participants with troponin levels above upper limit of normal at screening (as defined by the manufacturer) and without any myocardial infarction (MI)-related symptoms should have a cardiologic consultation before enrollment to rule out MI
Corrected QT interval (QTcF) prolongation > 470 msec (females) or >450 msec (males) based on average of the triplicate12-lead electrocardiogram at screening
History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
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
Multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated
History of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product
History of severe hypersensitivity reactions to other monoclonal antibodies
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
Substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the participant's participation in the clinical study or evaluation of the clinical study results
Known human immunodeficiency virus (HIV) infection
Known active, clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C), based on available blood tests, liver ultrasound, or liver biopsy results
Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade 1 or baseline
Pregnant, breastfeeding, or planning to become pregnant
Otherwise considered inappropriate for the study by the Investigator
Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg. pulmonary emboli within three months of the study randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.)
Any autoimmune, connective tissue or inflammatory disorders (e.g., Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening
Prior complete pneumonectomy
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