Lung Cancer Clinical Trial

Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab alone in participants with advanced or metastatic non-small cell lung cancer (NSCLC).

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Full Description

The primary objective of the study is to compare the efficacy of Dato-DXd and pembrolizumab with pembrolizumab alone in terms of either Progression Free Survival (PFS) or Overall Survival (OS) for participants with advanced or metastatic NSCLC without actionable genomic alterations whose tumor has high programmed death-ligand 1 (PD-L1) expression (TPS ≥50%) and who have not previously received systemic therapy for advanced or metastatic NSCLC.

Eligible participants will be randomized in a 1:1 ratio to the control arm (pembrolizumab alone) or the experimental arm (Dato-DXd and pembrolizumab). The study will be divided into 4 periods: Tissue Screening Period, Screening Period, Treatment Period, and Follow-up Period.

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Eligibility Criteria

Inclusion Criteria:

Participants eligible for inclusion in the study must meet all inclusion criteria within 28 days of randomization into the study.

Sign and date the Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
Adults ≥18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.

Histologically documented NSCLC that meets all of the following criteria:

Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition).
Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue.
No known actionable genomic alterations in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies.
Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
Tumor has high programmed death receptor-1 (PD-L1) expression (TPS ≥50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
Has an adequate treatment washout period before Cycle 1 Day 1.
Measurable disease based on local imaging assessment using RECIST Version 1.1.
Has left ventricular ejection fraction (LVEF) ≥50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
Has a life expectancy of at least 3 months.
Adequate bone marrow function within 7 days before randomization.

Exclusion Criteria:

Has received prior systemic treatment for advanced or metastatic NSCLC.

Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting:

Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
TROP2-targeted therapy.
Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.

History of another primary malignancy (beyond NSCLC) except for:

Malignancy treated with curative intent and with no known active disease ≥3 years before the first dose of study treatment and of low potential risk for recurrence.
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
Adequately treated carcinoma in situ without evidence of disease.
Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage ≤T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.

Uncontrolled or significant cardiovascular disease, including:

Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
Myocardial infarction within 6 months prior to randomization.
Uncontrolled angina pectoris within 6 months prior to randomization.
LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.

Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.

Clinically significant corneal disease.
Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy ≤7 days prior to the first dose of study drug.
Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection; is positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B (hepatitis b surface antigen, anti-HBs, anti-HBc, or hepatitis B virus [HBV] DNA) or hepatitis C virus (HCV RNA) infection.
Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
Had an allogeneic tissue/solid organ transplant.
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

740

Study ID:

NCT05215340

Recruitment Status:

Recruiting

Sponsor:

Daiichi Sankyo, Inc.

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There are 81 Locations for this study

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Ironwood Cancer and Research Center
Chandler Arizona, 85224, United States More Info
Principal Investigator
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The Oncology Institute of Hope and Innovation
Whittier California, 90603, United States More Info
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Johns Hopkins University
Baltimore Maryland, 21205, United States More Info
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American Oncology Partners of Maryland
Bethesda Maryland, 20817, United States More Info
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Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03766, United States More Info
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The Valley Hospital
Paramus New Jersey, 07652, United States More Info
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Utah Cancer Specialists
Salt Lake City Utah, 84106, United States More Info
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Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
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Austin Hospital
Heidelberg Victoria, 3084, Australia More Info
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Chris Obrien Lifehouse
Camperdown , 2050, Australia More Info
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The Queen Elizabeth Hospital
Woodville South , 5011, Australia More Info
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Onze-Lieve-Vrouwziekenhuis Olvz - Campus Aalst
Aalst , 9300, Belgium More Info
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Az Maria Middelares - Campus Maria Middelares
Gent , 9000, Belgium More Info
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AZ Nikolaas
Sint-Niklaas , 9100, Belgium More Info
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The First Affiliated Hospital of College of Medicine Zhejiang University
Hanghzou , 31000, China More Info
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Zhejiang Cancer Hospital
Hangzhou , 31002, China More Info
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Harbin Medical University Cancer Hospital
Harbin , 15008, China More Info
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Linyi Cancer Hospital
Linyi , 27600, China More Info
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The First Affiliated Hospital of Nanchang University
Nanchang , 33000, China More Info
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The Second People's Hospital of Neijiang
Neijiang , 64100, China More Info
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Shanghai Pulmonary Hospital
Shanghai , 20043, China More Info
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Liaoning Cancer Hospital& Institute
Shenyang City , 11080, China More Info
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The First Hospital of China Medical University
Shenyang , 11000, China More Info
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Union Hospital Affiliated With Tongji Medical College Huazhong University of Science and Technology
Wuhan , 43002, China More Info
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Centre Hospitalier Universitaire de Montpellier
Montpellier , 34295, France More Info
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Metropolitan Hospital
Neo Faliro Athens, 14564, Greece More Info
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Sotiria General Hosptial of Chest Diseases
Athens , 11527, Greece More Info
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University Hospital of Ioannina Uhi
Ioannina , 45500, Greece More Info
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Metropolitan Hospital
Neo Faliro , 18547, Greece More Info
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Semmelweis University Department of Pulmonology
Budapest , 1083, Hungary More Info
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Veszprem Megyei Tudogyogyintezet Farkasgyepu
Farkasgyepű , 8582, Hungary More Info
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Bkmk Hospital
KecskemĂŠt , 6000, Hungary More Info
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Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Szekesfehervar , 8000, Hungary More Info
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Pulmonology Hospital Torokbalint
Torokbalint , 2045, Hungary More Info
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Ifo Regina Elena
Rome , 144, Italy More Info
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Aomori Prefectural Central Hospital
Aomori-shi Aomori, 030-8, Japan More Info
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National Cancer Center Hospital East
Kashiwa-shi Chiba, 277-8, Japan More Info
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NHO Shikoku Cancer Center
Matsuyama-shi Ehime, 791-0, Japan More Info
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National Hospital Organization Kyushu Cancer Center
Fukuoka-shi Fukuoka, 811-1, Japan More Info
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Kyushu University Hospital
Fukuoka-shi Fukuoka, 812-8, Japan More Info
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Kurume University Hospital
Kurume-shi Fukuoka, 830-0, Japan More Info
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Kanazawa University Hospital
Kanazawa-shi Ishikawa, 920-8, Japan More Info
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Kanagawa Cancer Center
Yokohama-shi Kanagawa, 241-8, Japan More Info
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Saiseikai Kumamoto Hospital
Kumamoto-shi Kumamoto, 861- , Japan More Info
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Matsusaka Municipal Hospital
Matsusaka-shi Mie, 515-8, Japan More Info
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Sendai Kousei Hospital
Sendai-shi Miyagi, 980-0, Japan More Info
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Niigata Cancer Center Hospital
Niigata-shi Niigata, 961-8, Japan More Info
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Kansai Medical University Hospital
Hirakata-shi Osaka, 573-1, Japan More Info
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Osaka International Cancer Institute
Osaka-shi Osaka, 541-8, Japan More Info
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NHO Kinki-Chuo Chest Medical Center
Sakai-shi Osaka, 591-8, Japan More Info
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Saitama Cancer Center
Ina-machi Saitama, 362-0, Japan More Info
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Dokkyo Medical University Hospital
Shimotsuga-gun Tochigi, 321-0, Japan More Info
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Juntendo University Hospital
Bunkyo-ku Tokyo, 113-8, Japan More Info
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Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku Tokyo, 113-8, Japan More Info
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The Cancer Institute Hospital of JFCR
Koto-ku Toyko, 135-8, Japan More Info
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Toho University Omori Medical Center
Ota-ku Toyko, 143-8, Japan More Info
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NHO Iwakuni Clinical Center
Iwakuni-shi Yamaguchi, 740-8, Japan More Info
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Yamaguchi-Ube Medical Center
Ube-shi Yamaguchi, 755-0, Japan More Info
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Chungbuk National University Hospital
Cheongju-si Chungbuk, 28644, Korea, Republic of More Info
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Seoul National University Bundang Hospital
Seongnam Gyeonggi-do, 13620, Korea, Republic of More Info
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Kyungpook National University Chilgok Hospital
Daegu , 42119, Korea, Republic of More Info
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National Cancer Center
Goyang-si , 10408, Korea, Republic of More Info
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Samsung Medical Center
Seoul , 6351, Korea, Republic of More Info
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The Catholic Univ. of Korea, Seoul St. Mary'S Hospital
Seoul , 6591, Korea, Republic of More Info
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Asan Medical Center
Songpa-gu , 5505, Korea, Republic of More Info
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Instytut Centrum Zdrowia Matki Polki
Lodz Iodzkie, 93-33, Poland More Info
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Dom Lekarski SA
Szczecin Zachodniopomorskie, 70-78, Poland More Info
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II Klinika Chorob Pluc I Gruzlicy
Bialystok , 15-45, Poland More Info
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Hospital Universitari Vall D'Hebron
Barcelona , 8035, Spain More Info
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Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain More Info
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Hospital Regional Universitario Malaga
Malaga , 29010, Spain More Info
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CHUO
Ourense , 32005, Spain More Info
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Hospital Universitario Virgen Macarena
Sevilla , 41009, Spain More Info
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Hospital Universitari i Politècnic La Fe
Valencia , 46026, Spain More Info
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Kantonsspital Baden
Baden , 5404, Switzerland More Info
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Kantonsspital Baselland
Liestal , A4410, Switzerland More Info
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E-Da Hospital
Kaohsiung City , 824, Taiwan More Info
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Chang Gung Memorial Hospital Cgmh - Kaohsiung Branch
Kaohsiung , 833, Taiwan More Info
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Chung Shan Medical University Hospital
Taichung , 40201, Taiwan More Info
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National Cheng Kung University Hospital Nckuh
Tainan , 704, Taiwan More Info
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Taipei Veterans General Hospital
Taipei City , 11217, Taiwan More Info
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Chang Gung Memorial Hospital LinKou
Taoyuan , 333, Taiwan More Info
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How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

740

Study ID:

NCT05215340

Recruitment Status:

Recruiting

Sponsor:


Daiichi Sankyo, Inc.

How clear is this clinincal trial information?

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