HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy

Nonsquamous Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 3, Randomized, Open-label Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated (EGFRm) Non-small Cell Lung Cancer (NSCLC) After Failure of Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor (TKI) Therapy (HERTHENA-Lung02)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05338970
• Other study ID #: U31402-A-U301
• Secondary ID: 2021-005879-40jR
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 8, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: April 2024
• Source: Daiichi Sankyo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Disease progression is typical for patients with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC). Standard platinum-based chemotherapy offers limited efficacy and an unfavorable safety profile.There is an urgent need for more effective and tolerable therapies for patients with EGFRm NSCLC who have exhausted available targeted therapies. Clinical evidence suggest that patritumab deruxtecan constitutes a promising investigational therapy for patients with EGFRm NSCLC.

Description:

Patritumab deruxtecan (HER3-DXd, U3-1402) is an antibody-drug conjugate (ADC) comprising an anti-HER3 mAb linked to a topoisomerase I inhibitor that is in clinical development for patients with NSCLC, metastatic breast cancer, and colorectal cancer.

The primary objective of the current study is to compare the efficacy of patritumab deruxtecan versus platinum-based chemotherapy, as measured by progression-free survival (PFS) and the key secondary endpoint of overall survival (OS), in participants with metastatic or locally advanced NSCLC with an EGFR-activating mutation (exon 19 deletion or L858R) after failure of third-generation (eg, osimertinib, lazertinib, aumolertinib, alflutinib) EGFR TKI therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 586
• Est. completion date: June 30, 2026
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is a male or female subject aged =18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).

2. Has histologically or cytologically documented metastatic or locally advanced non-squamous NSCLC not amenable to curative surgery or radiation.

3. Has documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R at diagnosis or thereafter.

4. Received 1 or 2 prior line(s) of an approved EGFR TKI treatment in the metastatic or locally advanced setting, which must include a third -generation EGFR TKI

5. May have received either neoadjuvant and/or adjuvant treatment if progression to metastatic or locally advanced disease occurred at least 12 months after the last dose of such therapy and subsequently experienced disease progression on or after third-generation EGFR TKI treatment administered in the metastatic or locally advanced setting.

6. Has not received any other prior systemic therapies in the metastatic or locally advanced setting (including chemotherapy, immunotherapy etc) (even if administered in combination with EGFR TKI).

7. Has documentation of radiographic disease progression while receiving or after receiving a third generation EGFR TKI for metastatic or locally advanced disease.

8. Has at least 1 measurable lesion as per RECIST v1.1 by Investigator assessment.

9. Is willing to have a tumor biopsy or provide recently obtained tumor tissue.

10. Has an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.

11. Has adequate bone marrow reserve and organ function based on local laboratory evaluation within 14 days prior to randomization:

• Platelet count: =100,000/mm^3 or =100 × 10^9/L within 14 days prior to the assessment of platelet count during the Screening Period

• Absolute neutrophil count: =1500/mm^3 or =1.5 × 10^9/L within 14 days prior to the assessment of absolute neutrophil count during the Screening Period

• Hemoglobin (Hgb): =9.0 g/dL within 14 days prior to the assessment of hemoglobin during the Screening Period

• Creatine clearance (CrCl): CrCl =45 mL/min calculated by using the Cockcroft-Gault equation or measured CrCl

• Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT): AST/ALT =3× Upper limit of normal (ULN)

• Total bilirubin (TBL): TBL =1.5 × ULN

• Serum albumin: =2.5 g/dL

• Prothrombin time (PT) or Prothrombin time-International normalized ratio (PT-INR) and activated partial thromboplastin time (aPTT)/partial thromboplastin time (PTT): =1.5 × ULN, except for participants receiving coumarin-derivative anticoagulants or other similar anticoagulant therapy who must have PT-INR within therapeutic range as deemed appropriate by the Investigator

Exclusion Criteria:

1. Has 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, or squamous NSCLC histology

2. Has any history of interstitial lung disease (ILD) (including pulmonary fibrosis or radiation pneumonitis), has current ILD, or is suspected to have such disease by imaging during Screening

3. Has clinically severe respiratory compromise (based on the Investigator's assessment) resulting from intercurrent pulmonary illnesses including, but not limited to the following:

• Any underlying pulmonary disorder, restrictive lung disease, or pleural effusion

• Any autoimmune, connective tissue, or inflammatory disorders where there is documented, or a suspicion of pulmonary involvement at the time of Screening

• OR prior complete pneumonectomy

4. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior to randomization

5. Has any history of or evidence of current leptomeningeal disease

6. Has evidence of clinically active spinal cord compression or brain metastases, defined as being symptomatic and untreated, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms

7. Any prior treatment with any agent including an antibody drug conjugate (ADC) containing a chemotherapeutic agent targeting topoisomerase I, human epidermal growth factor receptor 3 (HER3) antibody, and any systemic therapies (other than EGFR TKIs) in the metastatic/locally advanced setting, including chemotherapy or any other systemic therapy in combination with an EGFR TKI

8. Has history of other active malignancy within 3 years prior to randomization, except for adequately resected nonmelanoma skin cancer, adequately treated intraepithelial carcinoma of the cervix, and any other curatively treated in situ disease

9. Has uncontrolled or significant cardiovascular disease prior to randomization

10. Has active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of active viral infection within 28 days of randomization

11. Has a known human immunodeficiency virus (HIV) infection that is not well controlled

12. Has clinically significant corneal disease

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Nonsquamous Non-small Cell Lung Cancer

Intervention

Drug:
• Patritumab Deruxtecan
Intravenous administration, 5.6 mg/kg every 3 weeks (q3W)
• Platinum-based chemotherapy
Intravenous, pemetrexed 500 mg/m^2 plus either cisplatin (75 mg/m^2) or carboplatin (target area under the plasma concentration time curve of 5 [AUC5] by using the Calvert formula) q3W

Locations

Country	Name	City	State
Australia	The Chris O'Brien Lifehouse	Camperdown
Australia	St George Public Hospital	Kogarah
Australia	Liverpool Hospital	Liverpool
Australia	Austin Hospital	Melbourne
Australia	St John of God Subiaco Hospital	Subiaco
Australia	Princess Alexandra Hospital	Woolloongabba
Austria	Landeskrankenhaus Feldkirch	Feldkirch
Austria	Medizinische Universitaet Innsbruck	Innsbruck
Austria	Klinikum Klagenfurt Pulmologie	Klagenfurt
Austria	Klinikum Wels-Grieskirchen	Wels
Austria	Karl Landsteiner Institut fur Lungenforschung und pneumologische Onkologie c/o Klinik Floridsdorf	Wien
Belgium	Cliniques Universitaires Saint-Luc	Brussels
Belgium	UZ Leuven	Leuven
Belgium	AZ Sint Maarten Mechelen	Mechelen
Belgium	AZ Delta	Roeselare
Canada	William Osler Health System - Brampton Civic Hospital	Brampton
China	Peking University Cancer Hospital	Beijing
China	Jilin Cancer Hospital	Chang chun
China	Hunan Cancer Hospital	Changsha
China	University of Electronic Science Technology of China UESTC - Sichuan Cancer Hospital Institute Sichuan Provincial Tumor Hospital	Chengdu
China	National Cancer Center Hospital East	Chibi
China	Fujian Medical University - Union Hospital Foochow Christian Union Hospital	Fuzhou
China	Guangdong Academy of Medical Science (GAMS) - Guangdong Provincial Peoples Hospital	Guangzhou
China	The First Affiliated Hospital Sun-Yat-Sen University	Guangzhou
China	Pecking University Third Hospital	Haidian
China	The First Affiliated Hospital of College of Medicine Zhejiang University	Hangzhou
China	Zhejiang Cancer hospital	Hangzhou
China	Harbin Medical University - Tumor Hospital The Third Affiliated Hospital	Harbin
China	The First Affiliated Hospital - Anhui Medical University Dept of Medical Oncology	Hefei
China	Henan Provincial Peoples Hospital	Henan
China	The Second Affiliated Hospital of Kunming Medical University	Kunming
China	Lin Yi Cancer Hospital	Linyi
China	General Hospital of Eastern Theater Command	Nanjing
China	The First Affiliated Hospital of Guangxi Medical University	Nanning
China	Fudan University - Shanghai Cancer Center FUSCC	Shanghai
China	Cancer Hospital of Shantou University Medical College	Shantou
China	The First Hospital of China Medical University	Shenyang
China	Affiliated Cancer Hospital of Xinjiang Medical University	Ürümqi
China	Huazhong University of Science and Technology - Tongji Medical College - Tongji Hospital TJH	Wuhan
China	Union Hospital of Tongji Medical College Huazhong University of Science and Technology	Wuhan
China	The First Affiliate Hospital of Xi'an Jiaotong University	Xi'an
China	Henan Cancer Hospital	Zhengzhou
France	Hopital Morvan CHU de Brest	Brest
France	Centre Francois Baclesse	Caen
France	Centre Francois Baclesse	Caen
France	Centre Leon Berard	Lyon
France	Montpellier Cancer Institute ICM	Montpellier
France	APHP - Hopital Saint Louis	Paris
France	Institut Curie	Paris Cedex 05
France	Centre Hospitalier Lyon Sud	Pierre-Bénite
France	Centre Hospitalier Universitaire (CHU) de Rennes - Hopital de Pontchaillou	Rennes
France	Institut de Cancrologie de lOuest ICO	Saint-Herblain
France	Gustave Roussy	Villejuif
Germany	Universitaetsklinikum Essen	Essen
Germany	Klinikum Esslingen GmbH	Esslingen
Germany	IKF Krankenhaus Nordwest	Frankfurt am main
Germany	Asklepios Fachklinik Muenchen-Gauting	Gauting
Germany	Universitatsklinik Giessen und Marburg	Gießen
Germany	LungenClinic Grosshansdorf	Großhansdorf
Germany	Thoraxklinik Heidelberg gGmbH	Heidelberg
Germany	LKI Lungenfachklinik Immenhausen	Immenhausen
Germany	Klinikverbund Allgaeu	Kempten
Germany	Pius-Hospital Oldenburg	Oldenburg
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Queen Elizabeth Hospital	Hong Kong
Hong Kong	University of Hong Kong/Queen Mary Hospital	Hong Kong
Italy	IRCCS Istituto Oncologico Giovanni Paolo II	Bari
Italy	University G. D'Annunzio Chieti	Chieti
Italy	Ospedale San Luca	Lucca
Italy	Asst Grande Ospedale Metropolitano Niguarda	Milano
Italy	IRCCS Istituto Europeo di Oncologia	Milano
Italy	Azienda Ospedaliero-Universitaria San Luigi Gonzaga	Orbassano
Italy	Azienda Ospedaliero Universitaria di Parma	Parma
Italy	Ospedale Santa Maria della Misericordia	Perugia
Italy	IFO Regina Elena	Roma
Italy	IRCCS Humanitas Research Hospital	Rozzano
Italy	ASST Sette Laghi	Varese
Japan	Hyogo Cancer Center	Akashi
Japan	Kyushu University Hospital	Fukuoka
Japan	Saitama Medical University International Medical Center	Hidaka
Japan	Kansai Medical University Hospital	Hirakata
Japan	Iwakuni Clinical Center	Iwakuni
Japan	Izumi City General Hospital	Izumi
Japan	Kanazawa University Hospital	Kanazawa
Japan	The Cancer Institute Hospital of JFCR	Koto-Ku
Japan	Saiseikai Kumamoto Hospital	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki
Japan	Kurume University Hospital	Kurume
Japan	Matsusaka Municipal Hospital	Matsusaka
Japan	NHO Shikoku Cancer Center	Matsuyama
Japan	National Hospital Organization Nagoya Medical Center	Nagoya
Japan	Niigata Cancer Center Hospital	Niigata
Japan	Okayama University Hospital	Okayama
Japan	Kindai University Hospital	Osaka-sayama
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo
Japan	Sendai Kousei Hospital	Sendai
Japan	Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital	Tokyo
Japan	Fujita Health University Hospital	Toyoake
Japan	Wakayama Medical University Hospital	Wakayama
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si
Korea, Republic of	National Cancer Center	Goyang
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Marys Hospital	Seoul
Netherlands	Netherlands Cancer Institute	Amsterdam
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	St. Jansdal Ziekenhuis	Harderwijk
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus MC	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht
Norway	Akershus University Hospital	Nordbyhagen
Norway	Oslo University Hospital-The Norwegian Radium Hospital	Oslo
Norway	Stavanger University Hospital	Stavanger
Poland	II Klinika Chorob Pluc i Gruzlicy	Bialystok
Poland	Onko-Centrum Sp. z o.o.	Lublin
Poland	Med Polonia Sp. z o.o.	Poznan
Portugal	Centro Clinico Champalimaud	Lisboa
Portugal	Instituto Portugues de Oncologio de Lisboa	Lisbon
Portugal	Centro Hospitalar de Vila Nova de Gaia - Espinho	Porto
Portugal	Centro Hospitalar Universitario do Porto - Hospital de Santo Antonio	Porto
Singapore	ICON Cancer Centre	Singapore
Singapore	National Cancer Centre Singapore NCCS	Singapore
Singapore	National University Cancer Institute National University Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Spain	Hospital Teresa Herrera C.H.U.A.C.	A Coruña
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Complejo Hospitalario Materno-Insular - Hospital Insular de Gran Canaria	Las Palmas De Gran Canaria
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	MD Anderson Cancer Center	Madrid
Spain	Hospital Regional Universitario Malaga	Málaga
Spain	Hospital Univeritario Marques de Valdecilla	Santander
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Switzerland	Kantonsspital Graubuenden - Hauptstandort	Chur
Switzerland	Kantonsspital Winterthur KSW	Winterthur
Taiwan	E-Da Hospital	Kaohsiung City
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospital NCKUH	Tainan
Taiwan	National Taiwan University Hospital NTUH	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital-Linkou Branch	Taoyuan
United Kingdom	University Hospital Birmingham NHS Trust	Birmingham
United Kingdom	Beatson West of Scotland Cancer Centre	Glasgow
United Kingdom	Leeds Cancer Centre	Leeds
United Kingdom	University Hospitals of Leicester	Leicester
United Kingdom	Barts and The London NHS Trust - St Bartholomew s hospital - PET CT Centre	London
United Kingdom	The Royal Marsden Hospital NHS Foundation Trust	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	The Christie Hospital	Manchester
United Kingdom	The Royal Wolverhampton NHS Trust	Wolverhampton
United States	Alaska Oncology and Hematology LLC	Anchorage	Alaska
United States	Emory University	Atlanta	Georgia
United States	American Oncology Partners of Maryland	Bethesda	Maryland
United States	St Luke's Cancer Institute	Boise	Idaho
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	City of Hope	Duarte	California
United States	Inova Schar Cancer Institute	Fairfax	Virginia
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Moores Cancer Center at the UC San Diego Health	La Jolla	California
United States	Scripps MD Anderson Cancer Center	La Jolla	California
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Hackensack Meridian Health-Southern Ocean Medical Center	Manahawkin	New Jersey
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Sarah Cannon/Florida Cancer Specialists - FCS South	Port Charlotte	Florida
United States	Providence Portland Medical Center	Portland	Oregon
United States	Highlands Oncology	Springdale	Arkansas
United States	Kaiser Permanente - Vallejo Medical Center	Vallejo	California
United States	Innovative Clinical Research Institute	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  France,  Germany,  Hong Kong,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Poland,  Portugal,  Singapore,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Based on RECIST v1.1	Progression-free survival (PFS) is defined as the time from the date of randomization to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.	Baseline up to approximately 49 months
Secondary	Overall Survival (OS)	Overall survival (OS) is defined as the time from the date of randomization to the date of death due to any cause.	Baseline up to approximately 49 months
Secondary	Progression-free Survival (PFS) as Assessed by Investigator Review Based on RECIST v1.1	Progression-free survival (PFS) is defined as the time from the date of randomization to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.	Baseline up to approximately 49 months
Secondary	Progression-free Survival (PFS) as Assessed by Local Standard Clinical Practice	Progression-free survival (PFS) by local standard clinical practice is defined as the time from date of randomization to the documented progression on the first new anticancer therapy (if administered) or death due to any cause, whichever occurred first.	Baseline up to approximately 49 months
Secondary	Objective Response Rate (ORR) as Assessed by BICR and Investigator Review Based on RECIST v1.1	Objective response rate (ORR) is defined as the proportion of participants who have a confirmed best overall response (BOR) of complete response (CR) or partial response (PR).	Baseline up to approximately 49 months
Secondary	Duration of Response (DoR) as Assessed by BICR and Investigator Review Based on RECIST v1.1	Duration of response (DoR) is defined as the time from the first documentation of objective response (CR or PR) to the earlier of the dates of the first documentation of objective progression of disease or death due to any cause.	Baseline up to approximately 49 months
Secondary	Clinical Benefit Rate (CBR) as Assessed by BICR and Investigator Review Based on RECIST v1.1	Clinical benefit rate (CBR) will be assessed by BICR and Investigator based on RECIST v1.1. CBR is defined as the proportion of participants who have a confirmed BOR of CR, PR, or stable disease (SD) that lasts for at least 180 days.	Baseline up to approximately 49 months
Secondary	Disease Control Rate (DCR) as Assessed by BICR and Investigator Review Based on RECIST v1.1	Disease control rate (DCR) is defined as the proportion of participants who have a confirmed BOR of CR, PR, or SD.	Baseline up to approximately 49 months
Secondary	Time to Response (TTR) as Assessed by BICR and Investigator Review Based on RECIST v1.1	Time to response (TTR) is defined as the time from the date of randomization to the date of the first documentation of response (CR or PR) that is subsequently confirmed.	Baseline up to approximately 49 months
Secondary	Intracranial PFS as Assessed by BICR	Intracranial PFS is defined as the time from the date of randomization to the earlier of the dates of the first documented radiographic intracranial disease progression or death, whichever comes first, as assessed by BICR per CNS-RECIST, in participants with CNS lesion(s) at baseline by BICR per CNS-RECIST.	Baseline up to approximately 49 months
Secondary	Mean Change from Baseline in Non-small Cell Lung Cancer - Symptom Assessment Questionnaire	The NSCLC-SAQ will assess disease-related symptom change in patients with NSCLC.	Baseline up to approximately 49 months
Secondary	Mean Change from Baseline in Patient's Global Impression of Change	The PGI-C is a 7-point scale depicting a participant's rating of overall improvement.	Baseline up to approximately 49 months
Secondary	Mean Change from Baseline in Patient's Global Impression of Severity	The PGI-S is a one-item questionnaire that contains six response options.	Baseline up to approximately 49 months
Secondary	Mean Change from Baseline in Patient's Global Impression of Treatment Tolerability	The PGI-TT will capture the patient's overall impression of treatment tolerability.	Baseline up to approximately 49 months
Secondary	Mean Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)	The EORTC-QLQ-C30 will assess the patient's overall quality of life (QoL).	Baseline up to approximately 49 months
Secondary	Mean Change from Baseline in EuroQol Questionnaire-5 dimensions-5 levels (EQ-5D-5L)	The EQ-5D-5L is a standardized instrument that will be used for measuring generic health status required for health technology assessments.	Baseline up to approximately 49 months
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	TEAEs will be graded by using National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.	Baseline up to approximately 49 months
Secondary	Percentage of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline)	The immunogenicity of patritumab deruxtecan will be confirmed by assessing the anti-drug antibodies.	Baseline up to approximately 49 months
Secondary	Percentage of Participants Who Have Treatment-emergent ADA	The immunogenicity of patritumab deruxtecan will be confirmed by assessing the anti-drug antibodies.	Baseline up to approximately 49 months