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Patritumab Deruxtecan in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT04676477
Recruitment Status : Not yet recruiting
First Posted : December 21, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.

Brief Summary:

This study includes a Dose Escalation Part to identify the recommended combination dose (RCD) and a Dose Expansion Part to further evaluate efficacy and safety.

The primary objectives:

Dose Escalation: To assess the safety and tolerability of patritumab deruxtecan (U3-1402) and osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib, and to determine the recommended combination dose (RCD).

Second-Line Dose Expansion Arm 1 and Arm 1b: To assess the preliminary antitumor activity of patritumab deruxtecan and osimertinib in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. Note: One or both of the study arms may open with one or two distinct dosing schedules.

Second-Line Dose Expansion Arm 2: To assess the preliminary antitumor activity of patritumab deruxtecan monotherapy in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib.

First-Line Dose Expansion: To assess the safety and tolerability of patritumab deruxtecan and osimertinib in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation without prior systemic treatment for locally advanced or metastatic disease.


Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC) Drug: Patritumab deruxtecan Drug: Osimertinib Phase 1

Detailed Description:

Dose Escalation:

Population includes subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. The starting combination dose regimen is patritumab deruxtecan 3.2 mg/kg IV every 21 days (Q3W) and osimertinib 80 mg orally (PO) once daily. At least 3 to 6 subjects will be enrolled in each cohort.

Dose Expansion: Two subject populations will be evaluated in the Dose Expansion Part:

  • Second-Line: Subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib
  • First-Line: Subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation, and without prior systemic therapy for advanced or metastatic disease. Note: The first line expansion will only be initiated if the RCD includes osimertinib 80 mg PO once daily.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Open-Label Study of Patritumab Deruxtecan in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Osimertinib

Arm Intervention/treatment
Experimental: Dose Escalation: Patritumab deruxtecan + osimertinib
Participants in the Dose Escalation phase will receive patritumab deruxtecan IV Q3W + osimertinib PO once daily. The dose of patritumab deruxtecan in the first cohort will be 3.2 mg/kg Q3W. The dose of osimertinib in the first cohort will be 80 mg PO once daily.
Drug: Patritumab deruxtecan
Intravenous infusion at a starting dose of 3.2 mg/kg Q3W
Other Names:
  • U3-1402
  • HER3-DXd

Drug: Osimertinib
Oral administration at 40 mg or 80 mg once daily

Experimental: Second-line Dose Expansion: Patritumab deruxtecan + osimertinib (RCD)
Participants in the Second-line Dose Expansion phase will be randomized to receive patritumab deruxtecan + osimertinib at the RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)
Drug: Patritumab deruxtecan
Intravenous infusion at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)
Other Names:
  • U3-1402
  • HER3-DXd

Drug: Osimertinib
Oral administration at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)

Experimental: Second-line Dose Expansion: Patritumab deruxtecan
Participants in the Second-line Dose Expansion phase will be randomized to receive patritumab deruxtecan 5.6 mg/kg IV Q3W
Drug: Patritumab deruxtecan
Intravenous infusion 5.6 mg/kg Q3W
Other Names:
  • U3-1402
  • HER3-DXd

Experimental: First-line Dose Expansion: Patritumab deruxtecan + osimertinib (RCD)
If the RCD includes an osimertinib dose of 80 mg PO once daily, then participants will receive treatment with patritumab deruxtecan and osimertinib at the RCD or, if relevant, at one of the provisional RCDs once established in dose escalation
Drug: Patritumab deruxtecan
Intravenous infusion at the selected RCD
Other Names:
  • U3-1402
  • HER3-DXd

Drug: Osimertinib
Oral administration at 80 mg once daily




Primary Outcome Measures :
  1. Dose Escalation: Incidence of Dose-limiting Toxicities (DLT), Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI) [ Time Frame: From signing of informed consent form up to 40 days (+7 days) after the last dose of study drugs, up to approximately 9 months ]
    A DLT is defined as any TEAE not attributable to disease or disease-related processes that occurs during the DLT evaluation period and is ≥Grade 3, with exceptions as defined in the protocol. A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. AEs will be coded using MedDRA and graded using NCI-CTCAE v5.0.

  2. Second-line Dose Expansion: Objective Response Rate (ORR) [ Time Frame: From start of study treatment until date of documented disease progression or other protocol-defined reason for discontinuation from the study (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 18 months ]
    ORR is defined as the proportion of participants who achieved a best overall response of confirmed complete response (CR) or confirmed partial response (PR) as assessed by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors version (RECIST) v1.1.

  3. First-line Dose Expansion: Incidence of Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI) [ Time Frame: From signing of informed consent form up to 40 days (+7 days) after the last dose of study drugs, up to approximately 18 months ]
    A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. Adverse events will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.


Secondary Outcome Measures :
  1. Dose Escalation and First-line Dose Expansion: Objective Response Rate (ORR) [ Time Frame: From start of treatment until date of disease progression or other reason for discontinuation (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 9 months (Dose Escalation) and 18 months (Dose Expansion) ]
    ORR is defined as the proportion of participants who achieved a best overall response of confirmed CR or confirmed PR as assessed by BICR and Investigator per RECIST v1.1.

  2. Second-line Dose Expansion: Objective Response Rate (ORR) [ Time Frame: From start of study treatment until the date of documented disease progression or other protocol-defined reason for discontinuation from the study (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 18 months ]
    ORR is defined as the proportion of participants who achieved a best overall response of confirmed CR or PR as assessed by Investigator per RECIST v1.1.

  3. Dose Escalation, Second-line Dose Expansion, and First-Line Dose Expansion: Duration of Response (DoR) [ Time Frame: From start of treatment until date of disease progression or other reason for discontinuation (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 9 months (Dose Escalation) and 18 months (Dose Expansion) ]
    DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first. DoR as assessed by BICR and Investigator per RECIST v1.1

  4. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Disease Control Rate (DCR) [ Time Frame: From start of treatment until date of disease progression or other reason for discontinuation (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 9 months (Dose Escalation) and 18 months (Dose Expansion) ]
    DCR is defined as the proportion of participants who achieved a best overall response of confirmed CR, confirmed PR, or stable disease (SD) as assessed by BICR and by Investigator per RECIST v1.1.

  5. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Time to Response (TTR) [ Time Frame: From start of treatment until date of disease progression or other reason for discontinuation (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 9 months (Dose Escalation) and 18 months (Dose Expansion) ]
    TTR is defined as the time from the start of study treatment to the date of the first documentation of response (confirmed CR or confirmed PR) in responding participants as assessed by BICR and by Investigator per RECIST v1.1.

  6. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Progression-free Survival (PFS) [ Time Frame: From start of treatment until date of disease progression or other reason for discontinuation (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 9 months (Dose Escalation) and 18 months (Dose Expansion) ]
    PFS is defined as the time from the start of study treatment to the date of the first documentation of objective PD as assessed by BICR and by Investigator per RECIST v1.1. or death due to any cause, whichever occurs first

  7. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Overall Survival (OS) [ Time Frame: From start of treatment until date of disease progression or other reason for discontinuation (e.g, withdrawal of consent, lost to follow-up), whichever occurs first, up to approximately 9 months (Dose Escalation) and 18 months (Dose Expansion) ]
    OS is defined as the time from the start of study treatment to the date of death due to any cause

  8. Second-line Dose Expansion: Incidence of Treatment-emergent Adverse Events (TEAE), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI) [ Time Frame: From signing of informed consent form up to 40 (+7 days) days after the last dose of study drugs, up to approximately 18 months ]
    A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is an important medical event, or may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes noted. AESIs will also be assessed. Adverse events will be coded using MedDRA and will be graded using NCI-CTCAE v5.0.

  9. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA [ Time Frame: From the start of study treatment until the end of treatment or study discontinuation (whichever occurs first), up to approximately 9 months (Dose Escalation) and 18 months (Dose Expansion) ]
    The immunogenicity of patritumab deruxtecan will be assessed.

  10. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Pharmacokinetic Parameter Maximum Concentration (Cmax) [ Time Frame: Patritumab deruxtecan: Cycles 1 and 3, Day 1 pre- and postdose, 4 hours (h), Days 8 and 15; Cycle 2, Day 1 pre- and postdose; Cycles 4, 6, 8, Day 1 pre- and postdose; Osimertinib: Cycles 1, 2, and 3, Day 1 pre- and postdose, 4 h (each cycle is 21 days) ]
    Cmax will be assessed for patritumab deruxtecan, total anti-HER3 antibody, MAAA-1181a, osimertinib (except for Second-line Dose Expansion Arm 2), and AZ5104 (active metabolite of osimertinib; except for Second-line Dose Expansion Arm 2).

  11. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) [ Time Frame: Patritumab deruxtecan: Cycles 1 and 3, Day 1 pre- and postdose, 4 hours (h), Days 8 and 15; Cycle 2, Day 1 pre- and postdose; Cycles 4, 6, 8, Day 1 pre- and postdose; Osimertinib: Cycles 1, 2, and 3, Day 1 pre- and postdose, 4 h (each cycle is 21 days) ]
    Tmax will be assessed for patritumab deruxtecan, total anti-HER3 antibody, MAAA-1181a, osimertinib (except for Second-line Dose Expansion Arm 2), and AZ5104 (active metabolite of osimertinib; except for Second-line Dose Expansion Arm 2).

  12. Dose Escalation, Second-line Dose Expansion, and First-line Dose Expansion: Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) [ Time Frame: Patritumab deruxtecan: Cycles 1 and 3, Day 1 pre- and postdose, 4 hours (h), Days 8 and 15; Cycle 2, Day 1 pre- and postdose; Cycles 4, 6, 8, Day 1 pre- and postdose; Osimertinib: Cycles 1, 2, and 3, Day 1 pre- and postdose, 4 h (each cycle is 21 days) ]
    AUC up to the last quantifiable time (AUClast) and AUC during dosing interval (AUCtau) will be assessed for patritumab deruxtecan, total anti-HER3 antibody, MAAA-1181a, osimertinib (except for Second-line Dose Expansion Arm 2), and AZ5104 (active metabolite of osimertinib; except for Second-line Dose Expansion Arm 2).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria Specific to Dose Escalation and Second-Line Dose Expansion:

  • Documentation of EGFR exon 19 deletion or L858R mutation detected from tumor tissue
  • Must have received osimertinib for locally advanced or metastatic disease at a dose of 80 mg once daily (QD) for at least 6 weeks and must not miss more than two doses during the 2 weeks prior to the first day of study treatment (Cycle 1, Day 1)
  • Must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting
  • Has documentation of radiological disease progression following first-line treatment with osimertinib in the locally advanced or metastatic setting

Inclusion Criteria Specific to First-line Dose Expansion:

  • The tumor tissue harbors one of the 2 common EGFR mutations occurring in NSCLC known to be associated with EGFR-TKI sensitivity (exon 19 deletion or L858R) as assessed by Clinical Laboratory Improvement Amendments (CLIA)-certified (United States [US] sites), accredited (outside of the US), local laboratory or central laboratory. Only tissue-based testing will be accepted.
  • Participants must have previously untreated locally advanced or metastatic NSCLC and must be eligible to receive first-line treatment with osimertinib, according to the judgment of the investigator. Prior adjuvant or neo-adjuvant therapy (chemotherapy, radiotherapy, investigational agents; except with osimertinib) is permitted.

All Participants:

Participants must meet all criteria to be eligible for inclusion in this study:

  • Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation.
  • At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
  • Willing to provide required tumor tissue of sufficient quantity (as defined in the laboratory manual) and contain adequate tumor tissue content (as confirmed by hematoxylin and eosin (H&E) staining at central laboratory). Required tumor tissue can be provided as either:

    • Pre-treatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy OR
    • Archival tissue collected from a biopsy performed within 3 months prior to signing of the tissue consent and since progression while on the most recent cancer therapy regimen.
    • On-study tumor biopsies are required for the first 15 participants in Dose Escalation.
  • Has adequate bone marrow reserve and organ function based on local laboratory data within 14 days prior to Cycle 1, Day 1 (Dose Escalation and First-Line Dose Expansion) or within 14 days prior to randomization (Second-Line Dose Expansion):

    • Platelet count: ≥100 000/mm^3 or ≥100 × 10^9/L (platelet transfusions are not allowed up to 14 days prior to Cycle 1, Day 1 to meet eligibility)
    • Hemoglobin: ≥9.0 g/dL (transfusion and/or growth factor support is allowed)
    • Absolute neutrophil count ; 1500/mm^3 or ≥1.5 × 10^9/L
    • Serum creatinine (SCr) OR creatinine clearance (CrCl): SCr ≤1.5 × ULN, OR CrCl ≥30 mL/min as calculated using the Cockcroft-Gault equation or measured CrCl; confirmation of CrCl is only required when creatinine is >1.5 × ULN
  • Aspartate aminotransferase/ alanine aminotransferase: ≤3 × ULN (if liver metastases are present, ≤5 × ULN)
  • Total bilirubin: ≤1.5 × ULN if no liver metastases (<3 × ULN in the presence of documented Gilbert's syndrome [unconjugated hyperbilirubinemia] or liver metastases)
  • Serum albumin ; ≥2.5 g/dL
  • Prothrombin time (PT) or PT-international normalized ratio (INR) and Activated partial thromboplastin time (aPTT) / Partial thromboplastin time (PTT): ≤1.5 × ULN, except for subjects on coumarin-derivative anticoagulants or other similar anticoagulant therapy, who must have PT-INR within therapeutic range as deemed appropriate by the Investigator.

Exclusion Criteria:

  • 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 pulmonary compromise (based on Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to:

    • Any underlying pulmonary disorder (eg, pulmonary emboli within three months of the study enrollment or randomization, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion);
    • Any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); OR prior complete pneumonectomy.
  • Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to Cycle 1, Day 1 (Dose Escalation and First-Line Dose Expansion) or prior to randomization (Second-Line Dose Expansion). 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, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive or treated brain metastases who are asymptomatic (ie, without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study.
  • Inadequate washout period prior to Cycle 1, Day 1 (Dose Escalation and First-Line Dose Expansion) or prior to randomization (Second-Line Dose Expansion) defined as:

    • Whole brain radiation therapy <14 days or stereotactic brain radiation therapy <7 days;
    • Any systemic anticancer (excluding osimertinib in all Dose Escalation Cohorts and in Second-Line Dose Expansion [Arms 1, 2, and 1b]), including investigational agents, <14 days or 5 half-lives, whichever is longer
    • Immune checkpoint inhibitor therapy <5 half-lives
    • Major surgery (excluding placement of vascular access) <4 weeks
    • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation < 28 days or palliative radiation therapy <14 days
    • Chloroquine or hydroxychloroquine ≤14 days
    • Medications or herbal supplemented known to be strong inducers of cytochrome P450 (CYP) 3A4 <21 days.
  • 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) version 5.0, Grade ≤1 or baseline. Subjects with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator after consultation with the Sponsor Medical Monitor or designee.
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow osimertinib, or previous significant bowel resection that would preclude adequate absorption of osimertinib.
  • Has any primary malignancy other than locally advanced or metastatic NSCLC within 3 years prior to Cycle 1, Day 1 (Dose Escalation and First-Line Dose Expansion) or within 3 years prior to randomization (Second-Line Dose Expansion), except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated.
  • Uncontrolled or significant cardiovascular disease prior to Cycle 1, Day 1 (Dose Escalation and First-Line Dose Expansion) or prior to randomization (Second-Line Dose Expansion) including:

    • Mean corrected QT interval using Fridericia's formula (QTcF) prolongation interval of >470 ms for females and >450 ms for males in 3 successive screening measurements
    • Left ventricular ejection fraction (LVEF) <50% by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan
    • Resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg
    • Myocardial infarction within 6 months
    • New York Heart Association (NYHA) Classes 2 to 4 congestive heart failure within 28 days
    • Uncontrolled angina pectoris within 6 months
    • Has cardiac arrhythmia requiring antiarrhythmic treatment
    • Complete left or right bundle branch block within 6 months
    • History of second- or third-degree heart block or PR interval >250 ms within 6 months
    • History of clinically relevant ventricular arrhythmias, such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes
    • Has any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives, or any concomitant medication known to prolong the QT interval
  • Has clinically significant corneal disease
  • Any evidence of severe or uncontrolled diseases including active bleeding diatheses, active infection, psychiatric illness/social situations, geographical factors, substance abuse, or other factors which in the Investigator's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04676477


Contacts
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Contact: (Japan sites) Daiichi Sankyo Contact for Clinical Trial Information +81-3-6225-1111 (M-F 9-5 JST) dsclinicaltrial@daiichisankyo.co.jp
Contact: (US sites) Daiichi Sankyo Contact for Clinical Trial Information 908-992-6400 CTRinfo@dsi.com

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215-5450
Contact: Principal Investigator         
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Principal Investigator         
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
Contact: Principal Investigator         
Japan
National Cancer Center Hospital
Chuo Ku, Tokyo, Japan, 104-0045
Contact: See Central Contact         
Kindai University Hospital
Ōsaka-sayama, Japan, 589-8511
Contact: See Central Contact         
Sponsors and Collaborators
Daiichi Sankyo, Inc.
Investigators
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Study Director: Global Clinical Leader Daiichi Sankyo, Inc.
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Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT04676477    
Other Study ID Numbers: U31402-A-U103
2020-003064-87 ( EudraCT Number )
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
URL: https://vivli.org/ourmember/daiichi-sankyo/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daiichi Sankyo, Inc.:
Advanced Non-small Cell Lung Cancer
Inoperable Non-small Cell Lung Cancer
Patritumab Deruxtecan (U3-1402)
Unresectable
Epidermal growth factor receptor
Metastatic
EGFR
Osimertinib
HER3
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Osimertinib
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs