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Clinical Trials List

Protocol NumberDS8201-793
NCT Number(ClinicalTrials.gov Identfier)NCT06899126
Active

2025-04-01 - 2033-01-20

Recruiting9

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A phase 3, multicenter, randomized, open-label trial evaluating trastuzumab deruxtecan plus pembrolizumab versus platinum-based chemotherapy plus pembrolizumab as first-line therapy in participants with locally advanced, unresectable or metastatic HER2 overexpression and PD-L1 TPS

  • Trial Applicant

     Daiichi Sankyo Taiwan Ltd. 

  • Sponsor

    daiichi sankyo Taiwan Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/10

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Hui Lee Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蕭聖諺 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳鵬宇 Division of Hematology & Oncology
Koo Foundation Sun Yat-Sen Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蔡鎮良 Division of Thoracic Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yung-Hung Luo Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chih-Hsi Kuo
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

The efficacy of T-DXd with pembrolizumab versus platinum-based chemotherapy with pembrolizumab was compared using PFS as assessed by BICR. PFS was defined as the time interval elapsed from the date of randomization to the date of radiographic disease progression or death from any cause. Tumor response was assessed by BICR tumor scans and determined using the Solid Tumor Response Assessment Criteria, version 1.1 (RECIST v1.1).

Objectives

Evaluate the efficacy and safety of T-DXd plus pembrolizumab compared to platinum-based chemotherapy plus pembrolizumab in participants with locally advanced, unresectable, or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have human epidermal growth factor receptor 2 (HER2) overexpression and planned cell death-ligand 1 (PD-L1) tumor proportion fraction (TPS) < 50% (with no known actionable genomic variants [AGAs]).

Test Drug

Trastuzumab Deruxtecan

Active Ingredient

Trastuzumab Deruxtecan

Dosage Form

Frozen Crystal Injection

Dosage

100mg/vial

Endpoints

The efficacy of T-DXd with pembrolizumab versus platinum-based chemotherapy with pembrolizumab was compared using PFS as assessed by BICR. PFS was defined as the time interval elapsed from the date of randomization to the date of radiographic disease progression or death from any cause. Tumor response was assessed by BICR tumor scans and determined using the Solid Tumor Response Assessment Criteria, version 1.1 (RECIST v1.1).

Inclution Criteria

Participants must meet all of the following criteria to be eligible for randomization to this trial:

1. Sign and date a Tissue Screening Participant Consent Form (ICF) before any tissue screening procedure. Sign and date a Primary Participant Consent Form before starting any trial-specific eligibility procedure. Sign and date a Selective PGx Participant Consent Form (included in the Primary Screening Participant Consent Form) before any pharmacogenomics (PGx) procedure, and, where applicable, a Pregnant Partner Participant Consent Form.

2. Be an adult ≥18 years of age at the date of signing the Participant Consent Form. If the legal age of consent for trial participation is >18 years, local regulations shall apply.

3. Histologically confirmed non-squamous locally advanced unresectable or metastatic NSCLC, and meet all of the following criteria:

- Have stage IV or IIIB or IIIC NSCLC, but are not eligible for surgical resection or eradicative concurrent chemoradiotherapy at the time of randomization (according to the American Joint Committee on Cancer, 8th edition).

- No known actionable genetic variants (AGAs) (based on available local testing results) that would allow for first-line treatment of any available targeted therapy against the AGAs in the local context.

- No known HER2 mutations based on available testing results (if approved or if validated locally).

Note: Participants with a mixed histological morphology are eligible if the tumor is predominantly adenocarcinoma. Mixed tumors will be classified according to the predominant cell type.

4. No prior systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who have received adjuvant or pre-adjuvant therapy other than the following treatments, including immune checkpoint inhibitors (ICIs) (i.e., anti-PD-1/PD-L1) or platinum-based regimens, are eligible if the last dose of adjuvant/pre-adjuvant therapy was administered at least 6 months prior to the date of the first trial dose, and their condition has not worsened within 6 months of the date of the last dose of adjuvant/pre-adjuvant therapy.

a. Any chemotherapy agent containing a target type I topoisomerase, including ADCs.

b. HER2-targeted antibody-based anticancer therapy.

5. Sufficient tumor tissue specimens (previously un-radiated) are available for assessment of HER2 and PD-L1 performance by the central or trial commissioner-designated laboratory. If a participant's most recent stock of tumor tissue specimens is unavailable, new sections are required.

6. The tumor exhibits HER2 overexpression, confirmed by the central or trial commissioner-designated laboratory using the Daiichi Sankyo-specified HER2 assay.

7. The tumor's PD-L1 TPS is <50%, confirmed by the central laboratory using the PD-L1 22C3 PharmDx assay.

8. The East Coast Cancer Clinical Research Cooperative (ECOG) performance status (PS) assessed 7 days prior to randomization is 0 or 1.

9. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization. 10. Adequate organ and bone marrow function must be maintained for 14 days prior to randomization. No transfusions (red blood cells [RBC] or platelets) or administration of granulocyte colony-stimulating factor (G-CSF) are permitted within 14 days prior to or after the day of bone marrow function assessment and before day 1 of cycle 1.

• Adequate organ/bone marrow function is defined as follows:

• Adequate bone marrow function: Platelet count ≥100,000/mm3; Heme >9.0 g/dL or ≥5.6 mmol/L (must be ineligible for erythropoietin and must be achieved without pRBC transfusion within the last 2 weeks); Absolute neutrophil count (ANC) ≥1500/mm3

• Adequate renal function: Measured or calculated creatinine clearance (CrCl) ≥60 mL/min, calculated using the Cockcroft-Gault formula.

• Adequate liver function: Alanine transaminase (ALT), aspartate transaminase (AST) ≤2.5 times the upper limit of normal (ULN) (≤5 times ULN for participants with liver metastases); Total bilirubin (TBL) ≤1.5 times ULN; or for total bilirubin (TBL)... Participants with a ULN >1.5 times are defined as having direct bilirubin ≤ULN and serum albumin ≥2.5 g/dL.

• Adequate coagulation function: prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT); ≤1.5 times ULN, unless the participant is receiving anticoagulation therapy, provided that PT/INR or aPTT/PTT is within the therapeutic range expected for the anticoagulant.

11. Sufficient treatment washout period before randomization/admission is defined as follows:

• Major surgery ≥4 weeks

• Radiation therapy, including palliative stereotactic radiotherapy to the chest ≥4 weeks

• Palliative stereotactic radiotherapy to other anatomical regions ≥2 weeks

• Chloroquine/Hydroxychloroquine >14 12. ≥2 weeks prior to screening assessment for cell-free concentrated ascites reinfusion, abdominal drainage, or drainage of pleural effusion, ascites, or pericardial effusion.

13. Participants who are female fertile (POCBP) are eligible to participate if they meet the following criteria:

• Confirmed not pregnant by a highly sensitive pregnancy test.

• Not breastfeeding during the trial intervention and for at least 7 months after the last dose of the trial intervention.

• Participants agree to adhere to highly effective contraception and agree not to donate eggs (ovaries, oocytes) or freeze/store eggs during the intervention and for at least the washout period required after the last dose of the trial intervention. The required duration of continuous contraception after the last dose of the trial intervention is 7 months. Egg preservation may be considered before the first dose of the trial intervention.

Male partners of POCBPs who are capable of producing sperm (using hormonal contraception) should use barrier contraception in addition to the treatment intervention and for 7 months after the last dose of the trial intervention. For participants receiving pembrolizumab, pemetrexed, carboplatin, and cisplatin, the trial unit should follow local instructions or institutional guidelines.

13. Male participants capable of producing sperm are eligible to participate if they agree to adhere to the following requirements during the intervention and at least for the duration required to wash out the trial intervention. The required duration of continuous contraception after the last dose of the trial intervention is 4 months.

• Avoid donating sperm.

Note: Sperm preservation should be considered before enrollment/randomization for this trial.

• Follow any of the following methods of contraception:

- Abstain from penile-vaginal intercourse, provided this is in line with the participant's preference and usual lifestyle, or

- Use a penile/external condom during penile-vaginal intercourse with a fertile non-participant, and the partner should use additional contraception, as condoms may break or leak.

The use of contraception should comply with local regulations regarding contraception methods for these clinical trial participants. If the contraceptive requirements for any trial intervention in the local instructions are more stringent than those above, the requirements in the local instructions should be followed.

Note: If a participant is azoospermic (due to vasectomy or medical reasons, confirmed by review of the participant's medical records, medical examinations, or medical history interviews by the trial unit personnel), contraception is not required.

14. Participants must be willing and able to adhere to scheduled follow-up appointments, medication administration plans, laboratory tests, other trial procedures, and trial restrictions.

15. Participants with asymptomatic central nervous system (CNS) metastases may participate if they do not require steroid or antiepileptic drug treatment for at least 14 days prior to the first dose of the trial intervention (Note: prophylactic antiepileptic drugs are permitted). Participants who have previously received treatment for brain metastases may participate, provided they are clinically and radiographically stable (i.e., without evidence of deterioration) for at least 4 weeks after the completion of radiation therapy, as confirmed by repeat imaging during the trial screening period.

Exclusion Criteria

Participants will be ineligible for this trial if they meet any of the following criteria:

1. History of myocardial infarction (MI) or symptomatic congestive heart failure (CHF) (NYHA Class II-IV) within 6 months prior to randomization/enrollment. Participants with troponin levels higher than the ULN (as defined by the manufacturer) at screening and without any MI-related symptoms should consult a cardiologist during screening to rule out MI.

2. A corrected QT interval (QTc) longer than 480 ms based on the average of three consecutive 12-lead electrocardiograms (ECGs) at screening.

3. A history of (non-infectious) interstitial lung disease (ILD)/pneumonia requiring steroids, current ILD/pneumonia, or suspected ILD/pneumonia that cannot be ruled out by angiography at screening.

4. Having a specific clinically significant pulmonary comorbidity, including but not limited to any underlying lung disease (e.g., pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion, etc. within 3 months of randomization to the trial).

5. Having previously undergone total pneumonectomy.

6. Having any autoimmune disease, connective tissue disease, or inflammatory disease with documented or suspected clinically significant pulmonary dysfunction at screening time (e.g., rheumatoid arthritis, Shugrange's disease, sarcoidosis, etc.).

7. Having active or uncontrolled hepatitis B virus (HBV) infection. Participants are eligible if they meet the following criteria:

a. They are hepatitis B surface antigen (HBsAg) positive and have chronic HBV infection (lasting 6 months or longer), and meet the following additional criteria:

• HBV deoxyribonucleic acid (DNA) viral load <2000 IU/mL

• Initiation or maintenance of antiviral therapy if the trial administrator deems it clinically necessary

b. Normal transaminase levels, or, if liver metastases are present, abnormal transaminase levels (AST/ALT <3 times ULN) that cannot be attributed to HBV infection.

8. They have active or uncontrolled hepatitis C virus (HCV) infection. Participants are eligible if they meet the following criteria:

a. They have a history of hepatitis C infection and, in the past 4 weeks, have an HCV viral load below detectable levels when not receiving antiviral therapy.

b. Normal transaminase levels, or, if liver metastases are present, abnormal transaminase levels (AST/ALT < 3 times ULN) that cannot be attributed to HCV infection.

9. Participants with active or uncontrolled human immunodeficiency virus (HIV) infection, including those with a history of Kaposi's sarcoma and/or multicentric Castleman disease. HIV viral load testing must be performed on participants during the screening period if permitted by local regulations or by the Investigative Human Board (IRB)/Independent Ethics Committee (IEC). Participants are eligible if they meet the following criteria:

a. A CD4+ T cell count ≥350 cells/mm3 at screening.

b. Virological suppression is defined as a confirmed HIV RNA concentration below 50 or the lower limit of quantitation (LLOQ) (below the detection limit) for at least 12 weeks at screening and prior to screening.

c. No opportunistic infection or illness defined as acquired immunodeficiency syndrome (AIDS) within the past 12 months.

d. Received a stable antiretroviral therapy (ART) regimen (without changes in medication or dose adjustment) for at least 4 weeks prior to entering the trial (Day 1) and agreed to continue ART throughout the trial.

10. Suffering from spinal cord compression, symptomatic CNS metastases, and/or carcinomatous meningitis.

11. History of a severe allergic reaction (≥ Grade 3) to any drug component or inactive ingredient in the medication. 12. Uncontrollable infection requiring systemic antibiotics, antiviral drugs, or antifungal medications.

13. Received a live attenuated vaccine within 30 days prior to the first dose of the trial (messenger RNA [mRNA] and replication-defective adenovirus vaccines are not considered live attenuated vaccines).

14. Unresolved toxicity from prior cancer treatment, defined as toxicity (excluding hair loss) not regressing to ≤ Grade 1 or the baseline period.

Note: Participants with chronic, stable Grade 2 toxicity (defined as not worsening to > Grade 2 within at least 3 months prior to randomization and controlled with standard care) and identified by the trial administrator as related to prior cancer therapy may be included, including:

• Chemotherapy-induced neuropathy

• Fatigue

• Residual toxicity from prior immuno-oncology therapy: Grade 1 or 2 endocrine disorders, which may include:

Hypothyroidism/Hyperthyroidism

Type 1 diabetes

Hyperglycemia

15. Adrenal insufficiency.

Adrenalitis.

Hypopigmentation (leukoderma).

16. Pregnant, breastfeeding, or planning to become pregnant.

17. Substance abuse or any other medical condition, such as a clinically significant cardiac or psychological condition, that the trial administrator deems may interfere with participation in the clinical trial or the evaluation of clinical trial results.

18. Active autoimmune disease requiring systemic treatment within the past 2 years (i.e., use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs). Complementary therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) are not considered systemic treatments and are permitted.

19. Diagnosed with immunodeficiency or currently receiving chronic systemic steroid therapy (at doses exceeding 10 mg of the prednisone equivalent daily), or receiving other forms of immunosuppressive therapy within 7 days prior to the first dose of the trial intervention. 19. Unable or unwilling to supplement with folic acid or vitamin B12.

20. Contraindications to pembrolizumab, pemetrexed, cisplatin, and carboplatin, as indicated on local product labeling.

21. Known to have other malignant tumors that are worsening or that have required aggressive treatment within the past 3 years.

Note: Participants with basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ (excluding bladder carcinoma in situ) who have received potentially curative therapies are not excluded.

22. History of allogeneic tissue/solid organ transplantation.

The Estimated Number of Participants

  • Taiwan

    22 participants

  • Global

    686 participants

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