ACTIVE_NOT_RECRUITING

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

Conditions

Metastatic Non Small Cell Lung Cancer Advanced Non Small Cell Lung Cancer Datopotamab Deruxtecan (Dato-DXd)Pembrolizumab Pemetrexed Tropion-Lung07

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)

Quick Facts

Study Start:2023-01-11

Study Completion:2027-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05555732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions. 2. Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is \>18 years old). 3. Has tumor with PD-L1 TPS \<50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of six slides). PD-L1 expression results available at the same central laboratory from screening for the purpose of entry into another Dato-DXd study may be used for tissue screening purposes in this study as long as the subject has not been randomized/enrolled in the other study. 4. Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron sections or block equivalent) for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers. This tissue requirement is in addition to the tissue required for PD-L1 testing for tissue screening purposes. If a documented law or regulation prohibits (or does not approve) sample collection, then such sample will not be collected, and the subject is still eligible for the study. 5. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Subjects who received adjuvant or neoadjuvant therapy other than those listed in the exclusion criteria are eligible if the adjuvant/ neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease and should not have progressed on or within the 6 months of completion. 6. Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days before randomization.	1. Has received prior systemic treatment for advanced/metastatic NSCLC. 2. Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting (for NSCLC): 1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I 2. TROP2-targeted therapy 3. Any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) 4. Any other ICIs Subjects 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 or metastatic disease. 3. Has received a live vaccine within 30 days prior to the first dose of study treatment. 4. Has spinal cord compression or clinically active untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 2 weeks by repeat imaging (Note: Repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 7 days before the first dose of study drug. Note: A contrasted computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of the brain at baseline (MRI with contrast preferred) is required for all subjects. For those subjects in whom CNS metastases are first discovered at the time of screening, the treating investigator must delay of study treatment to document stability of CNS metastases with repeat imaging at least 2 weeks later (in which case, repeat of all screening activity may be required). 5. Has uncontrolled or significant cardiovascular disease not controlled by maximal medical therapy, including: 1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval \>470 msec regardless of sex (based on the 12-lead electrocardiogram \[ECG\] performed at screening). 2. Myocardial infarction within 6 months prior to Cycle 1 Day 1. 3. History of a serious cardiac arrhythmia requiring treatment 4. Uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1. 5. Left ventricular ejection fraction (LVEF) \<50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization. 6. New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) at screening. Subjects with a history of Class II to IV CHF prior to screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible. 7. Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy). 6. Clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli diagnosed within 3 months of Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc) or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), or prior complete pneumonectomy.

Inclusion Criteria

Exclusion Criteria

1. Sign and date the Main ICF, prior to the start of any study- specific qualification procedures. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
2. Adults ≥18 at the time the Main ICF is signed. (Follow local regulatory requirements if the legal age of adult voluntary consent for study participation is \>18 years old).
3. Has tumor with PD-L1 TPS \<50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing (minimum of six slides). PD-L1 expression results available at the same central laboratory from screening for the purpose of entry into another Dato-DXd study may be used for tissue screening purposes in this study as long as the subject has not been randomized/enrolled in the other study.
4. Has provided a formalin-fixed tumor tissue sample (minimum of 4 × 4-micron sections or block equivalent) for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers. This tissue requirement is in addition to the tissue required for PD-L1 testing for tissue screening purposes. If a documented law or regulation prohibits (or does not approve) sample collection, then such sample will not be collected, and the subject is still eligible for the study.
5. Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Subjects who received adjuvant or neoadjuvant therapy other than those listed in the exclusion criteria are eligible if the adjuvant/ neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease and should not have progressed on or within the 6 months of completion.
6. Has measurable disease based on local imaging assessment using RECIST v1.1; radiographic tumor assessment must be performed within 28 days before randomization.

1. Has received prior systemic treatment for advanced/metastatic NSCLC.
2. Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant setting (for NSCLC):
1. Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I
2. TROP2-targeted therapy
3. Any anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137)
4. Any other ICIs Subjects 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 or metastatic disease.
3. Has received a live vaccine within 30 days prior to the first dose of study treatment.
4. Has spinal cord compression or clinically active untreated CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 2 weeks by repeat imaging (Note: Repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for at least 7 days before the first dose of study drug. Note: A contrasted computed tomography (CT) scan or magnetic resonance imaging (MRI) scan of the brain at baseline (MRI with contrast preferred) is required for all subjects. For those subjects in whom CNS metastases are first discovered at the time of screening, the treating investigator must delay of study treatment to document stability of CNS metastases with repeat imaging at least 2 weeks later (in which case, repeat of all screening activity may be required).
5. Has uncontrolled or significant cardiovascular disease not controlled by maximal medical therapy, including:
1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval \>470 msec regardless of sex (based on the 12-lead electrocardiogram \[ECG\] performed at screening).
2. Myocardial infarction within 6 months prior to Cycle 1 Day 1.
3. History of a serious cardiac arrhythmia requiring treatment
4. Uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
5. Left ventricular ejection fraction (LVEF) \<50% by echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 28 days before randomization.
6. New York Heart Association (NYHA) Class II-IV congestive heart failure (CHF) at screening. Subjects with a history of Class II to IV CHF prior to screening, must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.
7. Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg within 28 days before randomization that is not resolved despite maximal medical therapy).
6. Clinically severe pulmonary compromise as judged by the investigator resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli diagnosed within 3 months of Cycle 1 Day 1, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc) or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc), or prior complete pneumonectomy.

Contacts and Locations

Principal Investigator

Global Clinical Leader

STUDY_DIRECTOR

Daiichi Sankyo

Study Locations (Sites)

Southern Cancer Center Pc

Daphne, Alabama, 36526

United States

Ironwood Cancer and Research Centers

Chandler, Arizona, 85224

United States

Arizona Oncology Associates, Pc - Nahoa

Prescott Valley, Arizona, 86314

United States

Hoag Memorial Hospital Prebyterian

Newport Beach, California, 92663

United States

Compassionate Cancer Care Medical Group

Riverside, California, 92501

United States

Sansum Clinic

Santa Barbara, California, 93105

United States

Ronald Reagan UCLA Medical Center

Santa Monica, California, 90404

United States

UCHealth Memorial Hospital

Colorado Springs, Colorado, 80909

United States

Florida Cancer Specialists - South

Fort Myers, Florida, 33901

United States

Cancer Specialist of North Florida

Jacksonville, Florida, 32256

United States

Cancer Care Centers of Brevard, Inc.

Palm Bay, Florida, 32901

United States

Woodlands Medical Specialists, Pa

Pensacola, Florida, 32503

United States

Florida Cancer Specialists-North

St. Petersburg, Florida, 33705

United States

Emory University - Winship Cancer Institute Wci

Atlanta, Georgia, 30322-1013

United States

Illinois Cancer Specialists

Niles, Illinois, 60714

United States

American Oncology Partners of Maryland

Bethesda, Maryland, 20817

United States

Maryland Oncology Heamtology P.A.

Columbia, Maryland, 21044

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Dana Farber Cancer Institute; Inv Drg Svc Pharm

Boston, Massachusetts, 02215

United States

Dana Farber Cancer Institute At St. Elizabeth'S Medical Center

Brighton, Massachusetts, 02135

United States

Dana Farber Brigham Cancer Center

Foxborough, Massachusetts, 02035

United States

Dana Farber At Milford Regional Cancer Center

Milford, Massachusetts, 01757

United States

Dana Farber/Bwcc in Affiliation With South Shore Hospital

South Weymouth, Massachusetts, 02190

United States

Astera Cancer Care

East Brunswick, New Jersey, 08816

United States

Regional Cancer Care Associates LLC

Hackensack, New Jersey, 07601

United States

North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists- New Hyde Park

New Hyde Park, New York, 11042

United States

North Shore Hematology Oncology Associates

Patchogue, New York, 11772

United States

North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists

Port Jefferson Station, New York, 11776

United States

North Shore Hematology Oncology Associates dba NY Cancer and Blood Specialists - Bronx

The Bronx, New York, 10469

United States

Texas Oncology, P.A.

McAllen, Texas, 78503

United States

Ut Health San Antonio

San Antonio, Texas, 78229

United States

Texas Oncology, P.A.

Sugar Land, Texas, 77479

United States

Texas Oncology-Tyler

Tyler, Texas, 75702

United States

Utah Cancer Specialists IHO Corp

Salt Lake City, Utah, 84106

United States

Providence Regional Cancer System

Lacey, Washington, 98503

United States

VA Puget Sound Health Care System

Seattle, Washington, 98108

United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

Global Clinical Leader, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-11

Study Completion Date2027-08-01

Study Record Updates

Study Start Date2023-01-11

Study Completion Date2027-08-01

Terms related to this study

Keywords Provided by Researchers

Metastatic Non Small Cell Lung Cancer
Advanced Non Small Cell Lung Cancer
Datopotamab Deruxtecan (Dato-DXd)
Pembrolizumab
Pemetrexed
Tropion-Lung07

Additional Relevant MeSH Terms

Metastatic Non Small Cell Lung Cancer