Lung Cancer Clinical Trial

Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)

Summary

This study is designed to assess the efficacy and safety of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab versus pembrolizumab in combination with pemetrexed and platinum chemotherapy in participants with no prior therapy for advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).

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Full Description

The primary objectives of the study are Progression Free Survival (PFS) and Overall Survival (OS) as first line therapy in participants with programmed death-ligand 1 (PD-L1) TPS <50% and advanced or metastatic NSCLC without actionable genomic alternations.

Eligible participants will be randomized in a 1:1:1 ratio to a) Dato-DXd plus pembrolizumab plus platinum; b) Dato-DXd plus pembrolizumab; or c) pembrolizumab plus pemetrexed plus platinum. Platinum therapy will be either carboplatin or cisplatin at investigator discretion. The study will be divided into three periods: Screening Period (including tissue screening), Treatment Period, and Follow-up Period.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Sign and date the Main Informed Consent Form (ICF), prior to the start of any study- specific qualification procedures.
Adults ≥18 at the time the Main ICF is signed.
Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing.
Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC.
Has measurable disease based on local imaging assessment using RECIST v1.1.

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.
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
Has an adequate treatment washout period before Cycle 1 Day 1.
Is willing and able to participate in the collection of patient-reported outcomes (PRO) data.

Exclusion Criteria:

Has received prior systemic treatment for advanced/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.
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.
Has spinal cord compression or clinically active untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.

Uncontrolled or significant cardiovascular disease, including:

Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex.
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 within 28 days before randomization.
Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.

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.
Has a history of severe hypersensitivity reactions to either the drugs or inactive ingredients of Dato-DXd, pembrolizumab, carboplatin, cisplatin or pemetrexed.
Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
Has known human immunodeficiency virus (HIV) infection that is not well controlled.
Has active or uncontrolled hepatitis B or C infection.
Female who is pregnant or breastfeeding or intends to become pregnant.
Any other medical conditions, including cardiac disease or psychological disorders, and/or substance abuse.
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.
Has active, known, or suspected autoimmune disease.
Has clinically significant corneal disease.
Has had an allogeneic tissue/solid organ transplantation.
Has received prior radiotherapy ≤4 weeks of start of study intervention or more than 30 Gy to the lung within 6 months of Cycle 1 Day 1.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

975

Study ID:

NCT05555732

Recruitment Status:

Recruiting

Sponsor:

Daiichi Sankyo, Inc.

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There are 42 Locations for this study

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Ironwood Cancer and Research Centers
Chandler Arizona, 85224, United States More Info
Principal Investigator
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Compassionate Cancer Care Medical Group
Riverside California, 92501, United States More Info
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UCHealth Memorial Hospital
Colorado Springs Colorado, 80909, United States More Info
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Cancer Specialist of North Florida
Jacksonville Florida, 32256, United States More Info
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American Oncology Partners of Maryland
Bethesda Maryland, 20817, United States More Info
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Astera Cancer Care
East Brunswick New Jersey, 08816, United States More Info
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Regional Cancer Care Associates LLC
Hackensack New Jersey, 07601, United States More Info
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Utah Cancer Specialists IHO Corp
Salt Lake City Utah, 84106, United States More Info
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Providence Regional Cancer System
Lacey Washington, 98503, United States More Info
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CRSA/ St Andrews Hospital
Adelaide , 5000, Australia More Info
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PSEHOG (Peninsula and South Eastern Haematology and Oncology Group)
Frankston , 3199, Australia More Info
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Southern Medical Day Care Centre
Wollongong , 2500, Australia More Info
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Princess Alexandra Hospital
Woolloongabba , QLD 4, Australia More Info
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Shanghai Chest Hospital
Shanghai , 20005, China More Info
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Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan , 43002, China More Info
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Xiangyang Central Hospital
Xianyang , 44102, China More Info
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Kurume University Hospital
Azuma , , Japan More Info
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Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyō-Ku , 113-0, Japan More Info
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Kyushu University Hospital
Fukuoka , 812-0, Japan More Info
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Matsusaka Municipal Hospital
Hataji , , Japan More Info
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Kansai Medical University Hospital
Hirakata , 573-1, Japan More Info
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Iwakuni Clinical Center
Iwakuni , 740-8, Japan More Info
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Kanazawa University Hospital
Kanazawa-shi , 920-8, Japan More Info
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Juntendo University Hospital
Kanemaru , , Japan More Info
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The Cancer Institute Hospital of JFCR
Koto , 135-0, Japan More Info
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NHO Shikoku Cancer Center
Kozuki , , Japan More Info
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Social Welfare Organization Saiseikai Imperial Gift Foundation, Inc. Saiseikai Kumamoto Hospital
Kumamoto , 861-4, Japan More Info
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University Hospital Kyoto Prefectual University of Medicine
Kyoto , 602-8, Japan More Info
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Matsusaka City Hospital
Matsusaka , 515-8, Japan More Info
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Niigata Cancer Center Hospital
Niigata , 951-8, Japan More Info
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Kyushu Cancer Center
Okamato , , Japan More Info
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Teine Keijinkai Hospital
Sapporo-shi , 006-0, Japan More Info
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Sendai Kousei Hospital
Sendai , 980-0, Japan More Info
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Dokkyo Medical University Hospital
Shimotsuga-gun , 321-0, Japan More Info
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Osaka Toneyama Medical Center
Toyonaka-shi , 560-8, Japan More Info
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Yamaguchi-Ube Medical Center
Ube-shi , 755-0, Japan More Info
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Kanagawa Cancer Center
Yokohama , 241-8, Japan More Info
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Chungbuk National University Hospital
Cheongjusi , 28644, Korea, Republic of More Info
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Kyungpook National University Chilgok Hospital
Daegu , 41404, Korea, Republic of More Info
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Samsung Medical Center
Gangnam-Gu , 6351, Korea, Republic of More Info
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National Cancer Center
Goyang-si , 10408, Korea, Republic of More Info
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Seoul National University Bundang Hospital
Seongnam-si , 13620, Korea, Republic of More Info
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Asan Medical Center
Seoul , 05505, Korea, Republic of More Info
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China Medical University Hospital
Hsia , , Taiwan More Info
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National Taiwan University Hospital
Taipei , 10055, Taiwan More Info
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Siriraj Hospital
Bangkok , 10700, Thailand More Info
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Chiang Mai University CMU - Maharaj Nakhon Chiang Mai Hospital Nakorn Chiang Mai Hospital
Chiang Mai , 50200, Thailand More Info
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Khon Kaen University - Faculty of Medicine-Srinagarind Hospital
Mueang Nonthaburi , 40002, Thailand 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:

975

Study ID:

NCT05555732

Recruitment Status:

Recruiting

Sponsor:


Daiichi Sankyo, Inc.

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