Sendai Kousei Hospital | Clinical Trial Management Office
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About
This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.
Full description
This study will initially randomize participants to one of 2 arms in a 1:1 ratio to receive either a 5.6 mg/kg fixed dose regimen or an up-titration dose regimen of patritumab deruxtecan (HER3-DXd, U3-1402).
Enrollment
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Inclusion criteria
Participants must meet all of the following criteria to be eligible for inclusion in this study.
Sign and date the tissue informed consent form (ICF) and the main ICF, prior to the start of any study-specific qualification procedures.
Male or female participants aged ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation.
Documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Participants must have received both of the following:
Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.
At least 1 measurable lesion confirmed by BICR as per RECIST v1.1
Consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content. Required tumor tissue can be provided as either:
Eastern Cooperative Oncology Group Performance Standard of 0 or 1 at Screening.
Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to Cycle 1 Day 1:
Exclusion criteria
Participants meeting any exclusion criteria for this study will be excluded from this study.
Any previous histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreatment tumor biopsy.
Any history of interstitial lung disease (including pulmonary fibrosis or radiation pneumonitis), has current interstitial lung disease (ILD), or is suspected to have such disease by imaging during screening.
Clinically severe respiratory compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:
Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory or any form of immunosuppressive therapy prior to enrollment. Participants who require use of bronchodilators, inhaled or topical steroids, or local steroid injections may be included in the study.
Evidence of any leptomeningeal disease.
Evidence of clinically active spinal cord compression or brain metastases.
Inadequate washout period prior to Cycle 1 Day 1, defined as:
Prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody or single-agent topoisomerase I inhibitor.
Prior treatment with an antibody drug conjugate (ADC) that consists of any topoisomerase I inhibitor
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade ≤1 or baseline. Participants with chronic Grade 2 toxicities may be eligible at the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee.
Has history of other active malignancy within 3 years prior to enrollment, except:
Uncontrolled or significant cardiovascular disease prior to Cycle 1 Day 1
Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infection within 28 days of Cycle 1 Day 1.
Participant with any human immunodeficiency virus (HIV) infection.
Primary purpose
Allocation
Interventional model
Masking
277 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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