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Clinical Trials List

Protocol NumberDS8201-793
NCT Number(ClinicalTrials.gov Identfier)NCT06899126
Not yet recruiting

2025-04-01 - 2033-01-20

Phase III

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 of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS

  • Trial Applicant

     Daiichi Sankyo Taiwan Ltd. 

  • Sponsor

    DAIICHI SANKYO TAIWAN LTD.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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 Chih-Hsi Kuo Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

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
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Nonsquamous non–small cell lung cancer (NSCLC)

Objectives

To evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) in combination with pembrolizumab compared with platinum-based chemotherapy in combination with pembrolizumab in participants with previously untreated, locally advanced unresectable or metastatic nonsquamous non–small cell lung cancer (NSCLC) whose tumors exhibit human epidermal growth factor receptor 2 (HER2) overexpression and a programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) < 50%, and who have no known actionable genomic alterations (AGAs).

Test Drug

Trastuzumab Deruxtecan

Active Ingredient

Trastuzumab Deruxtecan

Dosage Form

243

Dosage

100 mg

Endpoints

To compare the efficacy of T-DXd in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab, as measured by progression-free survival (PFS) assessed by blinded independent central review (BICR).

PFS is defined as the time interval from the date of randomization to the date of radiographically documented disease progression or death from any cause, whichever occurs first.
Tumor response will be evaluated by BICR based on tumor imaging assessments and determined according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).

Inclution Criteria

Inclusion Criteria

Consent: Signs and dates the tissue-screening informed consent form (ICF) before any tissue-screening procedures; signs and dates the main ICF before any study-specific eligibility procedures; signs and dates the optional pharmacogenomics (PGx) ICF (included in the main screening ICF) before any PGx procedures; and, where applicable, signs and dates a pregnancy partner ICF.

Age: Adults ≥18 years at the time of ICF signing (or older if local regulations require a higher age of consent).

Disease type and setting: Histologically confirmed, nonsquamous, locally advanced unresectable or metastatic NSCLC meeting all of the following:

Stage IV NSCLC or Stage IIIB/IIIC disease not suitable at randomization for surgical resection or definitive concurrent chemoradiotherapy (AJCC 8th edition).

No known actionable genomic alterations (AGAs) (per available local testing) for which an approved first-line targeted therapy is available in the advanced/metastatic setting.

No known HER2 mutation per available testing (if an approved or locally validated test is available).
Note: Participants with mixed histology are eligible if the predominant histology is adenocarcinoma; mixed tumors are classified by the predominant cell type.

Prior systemic therapy: No prior systemic anticancer therapy for advanced/metastatic nonsquamous NSCLC. Prior adjuvant or neoadjuvant therapy—including ICIs (anti–PD-1/PD-L1) or platinum-based regimens—is permitted if the last dose was ≥6 months before the first study dose and there was no disease progression during or within 6 months after completing such therapy. The following prior therapies are not allowed:
a. Any topoisomerase I–targeting chemotherapeutic agents, including antibody–drug conjugates (ADCs).
b. HER2-targeted, antibody-based anticancer therapies.

Tumor tissue: Sufficient, non-irradiated tumor tissue available for central or sponsor-designated laboratory assessment of HER2 and PD-L1 expression. If an adequate archival sample is unavailable, a new biopsy is required.

HER2 status: HER2 overexpression confirmed by a central or sponsor-designated laboratory using the Daiichi Sankyo–specified HER2 assay.

PD-L1 status: PD-L1 TPS <50% confirmed by the central laboratory using PD-L1 22C3 pharmDx.

Performance status: ECOG PS 0–1 assessed within 7 days prior to randomization.

Cardiac function: LVEF ≥50% within 28 days prior to randomization.

Adequate organ and marrow function within 14 days prior to randomization. No transfusions (RBCs or platelets) or G-CSF are allowed from 14 days before marrow assessment through Cycle 1 Day 1.

Bone marrow: Platelets ≥100,000/mm³; Hemoglobin >9.0 g/dL or ≥5.6 mmol/L (without erythropoiesis-stimulating agents and no RBC transfusion within the prior 2 weeks); Absolute neutrophil count (ANC) ≥1,500/mm³.

Renal: Measured or calculated creatinine clearance (CrCl) ≥60 mL/min, calculated by the Cockcroft–Gault equation.

Hepatic: ALT/AST ≤2.5 × ULN (or ≤5 × ULN with liver metastases); Total bilirubin ≤1.5 × ULN, or if TBL >1.5 × ULN, then direct bilirubin ≤ ULN; Serum albumin ≥2.5 g/dL.

Coagulation: PT/INR and aPTT/PTT ≤1.5 × ULN, unless on therapeutic anticoagulation, in which case values must be within the intended therapeutic range.

Washout periods prior to randomization/enrollment:

Major surgery: ≥ 4 weeks.

Radiotherapy (including thoracic palliative SBRT): ≥ 4 weeks.

Palliative SBRT to non-thoracic sites: ≥ 2 weeks.

Chloroquine/Hydroxychloroquine: > 14 days.

Reinfusion of cell-free concentrated ascites, paracentesis, or drainage of pleural/peritoneal/pericardial effusions: ≥ 2 weeks before screening assessments.

Women of childbearing potential (WOCBP): Eligible if not pregnant by a high-sensitivity test, not breastfeeding during the intervention period and for ≥7 months after the last dose of study intervention, and agree to use highly effective contraception and not donate ova during the intervention period and for ≥7 months after the last dose. Oocyte cryopreservation may be considered before first dose.

For WOCBP with a male partner capable of fathering a child who uses hormonal contraception, an additional barrier method must be used during treatment and for 7 months after the last dose.

For participants receiving pembrolizumab, pemetrexed, carboplatin, or cisplatin, follow local labeling/institutional guidance if stricter.

Male participants capable of fathering a child: Eligible if they agree to the following during the intervention period and for ≥4 months after the last dose:

No sperm donation (sperm banking may be considered before enrollment/randomization).

Either complete abstinence from penile–vaginal intercourse (consistent with usual lifestyle), or use of a male condom during penile–vaginal intercourse with a woman of childbearing potential plus an additional effective method used by the partner. Contraception must comply with local regulations; if local labeling for any study drug is more stringent, follow local labeling.

No contraception required if azoospermic (vasectomized or medically azoospermic) as verified by site review of medical records/exam/history.

Compliance: Willing and able to comply with scheduled visits, dosing plan, laboratory tests, other study procedures, and study restrictions.

CNS metastases: Participants with asymptomatic CNS metastases may enroll if no corticosteroids or antiepileptics (prophylactic antiepileptics allowed) have been required for ≥14 days before the first study intervention. Participants with previously treated brain metastases may enroll if clinically and radiographically stable for ≥4 weeks after completion of radiotherapy, with stability confirmed by repeat imaging during screening.

Exclusion Criteria

Exclusion Criteria

Participants who meet any of the following conditions will be ineligible for this study:

History of myocardial infarction (MI) within 6 months before randomization/enrollment, or symptomatic congestive heart failure (CHF) of NYHA Class II–IV. Participants with elevated troponin levels above the ULN at screening (as defined by the manufacturer) without any MI symptoms must be evaluated by a cardiologist during screening to rule out MI.

Prolonged QTc interval >480 ms, based on the average of three consecutive 12-lead ECGs at screening.

History of (noninfectious) interstitial lung disease (ILD)/pneumonitis requiring steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

Clinically significant pulmonary comorbidities, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).

Prior total pneumonectomy.

Documented or suspected autoimmune, connective tissue, or inflammatory diseases with clinically significant pulmonary involvement (e.g., rheumatoid arthritis, Sjögren’s syndrome, sarcoidosis, etc.).

Active or uncontrolled hepatitis B virus (HBV) infection. Eligible if:
a. HBsAg-positive chronic HBV infection (≥6 months) and

HBV DNA <2000 IU/mL, and

Receiving or initiating antiviral therapy if deemed clinically necessary by the investigator.
b. Normal transaminase levels, or if hepatic metastases are present, AST/ALT <3 × ULN not attributable to HBV infection.

Active or uncontrolled hepatitis C virus (HCV) infection. Eligible if:
a. History of HCV infection with undetectable HCV RNA while off antiviral therapy for ≥4 weeks prior to screening, and
b. Normal transaminase levels, or if hepatic metastases are present, AST/ALT <3 × ULN not attributable to HCV infection.

Active or uncontrolled HIV infection, including those with a history of Kaposi’s sarcoma or multicentric Castleman’s disease.
If permitted by local regulations or IRB/IEC, HIV viral load testing must be performed during screening.
Eligible if:
a. CD4+ T-cell count ≥350 cells/mm³ at screening.
b. Virologically suppressed (HIV RNA <50 copies/mL or below LLOQ) at screening and for ≥12 weeks prior.
c. No AIDS-defining opportunistic infections or conditions in the past 12 months.
d. On a stable ART regimen for ≥4 weeks prior to Day 1 and willing to continue ART during the study.

Spinal cord compression, symptomatic CNS metastases, or carcinomatous meningitis.

Severe allergic reaction (≥Grade 3) to any active or inactive component of study drugs.

Uncontrolled active infection requiring systemic antibiotic, antiviral, or antifungal therapy.

Live-attenuated vaccine within 30 days before the first study intervention (note: mRNA and replication-deficient adenoviral vaccines are not considered live).

Unresolved toxicities from prior anticancer therapy, defined as >Grade 1 (except alopecia).
Note: Participants with chronic, stable Grade 2 toxicities (≥3 months without worsening and under standard management) deemed related to prior anticancer therapy may be eligible, including:
• Chemotherapy-induced neuropathy
• Fatigue
• Residual endocrine toxicities from prior immunotherapy (Grade 1–2), such as:

Hypothyroidism/hyperthyroidism

Type 1 diabetes

Hyperglycemia

Adrenal insufficiency

Adrenalitis

Vitiligo

Pregnant or breastfeeding, or planning pregnancy during the study.

Substance abuse or any clinically significant cardiac or psychiatric condition that, in the investigator’s judgment, could interfere with study participation or result interpretation.

Active autoimmune disease requiring systemic treatment (e.g., DMARDs, corticosteroids, or immunosuppressants) within the past 2 years. Replacement therapy (e.g., thyroid hormone, insulin, or physiologic corticosteroids for adrenal/pituitary insufficiency) is allowed.

Immunodeficiency diagnosis or chronic systemic corticosteroid therapy (>10 mg/day prednisone equivalent), or other immunosuppressive therapy within 7 days before first study dose.

Inability or unwillingness to take folic acid or vitamin B12 supplementation.

Contraindications to pembrolizumab, pemetrexed, cisplatin, or carboplatin per local labeling.

Concurrent or recent (within 3 years) active malignancy requiring treatment.
Note: Participants with basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma (except bladder carcinoma in situ) that has been curatively treated are not excluded.

History of allogeneic tissue or solid organ transplantation.

The Estimated Number of Participants

  • Taiwan

    22 participants

  • Global

    686 participants

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