試験ID jRCT2051240045
最終情報更新日：2026年10月23日
プラチナ製剤、エトポシド及びデュルバルマブ投与後の進展型小細胞肺癌患者を対象にタルラタマブとデュルバルマブの併用投与をデュルバルマブ単独投与と比較する第III相、非盲検、多施設共同、ランダム化試験（DeLLphi-305）
基本情報
| 試験ID | jRCT2051240045 | |
|---|---|---|
| 研究名称 / Scientific Title（Acronym） | プラチナ製剤、エトポシド及びデュルバルマブ投与後の進展型小細胞肺癌患者を対象にタルラタマブとデュルバルマブの併用投与をデュルバルマブ単独投与と比較する第III相、非盲検、多施設共同、ランダム化試験（DeLLphi-305） | A Phase 3, Open-label, Multicenter, Randomized Study of Tarlatamab in Combination With Durvalumab vs Durvalumab Alone in Subjects With Extensive-Stage Small-Cell Lung Cancer Following Platinum, Etoposide and Durvalumab (DeLLphi-305) |
| 平易な研究名称 / Public Title（Acronym） | Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab | |
| 試験進捗状況/Recruitment status | Not Recruiting | |
| 登録日時 | 2024年5月29日 | |
| 最終情報更新日 | 2026年10月23日 | |
| 試験開始日（予定日） | ||
| 試験終了日（予定日） | ||
| 組入れ開始日 / Date of first enrollment | ||
| 他の臨床研究登録機関発行の研究番号 | NCT06211036 | |
試験概要
| 試験実施地域 / Region | 日本 | United States,Japan,China,Japan,Switzerland,Japan,Turkey,Japan,Argentina,Japan,Australia,Japan,Brazil,Japan,Hong Kong,Japan,South Korea,Japan,Taiwan,Japan,Austria,Japan,Belgium,Japan,Canada,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Ireland,Japan,Israel,Japan,Italy,Japan,Mexico,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Spain,Japan |
|---|---|---|
| 実施都道府県 | 兵庫県 | |
| 目標症例数/Target sample size | 550 | |
| 対象疾患 / Health condition(s) or Problem(s) studied | 進展型小細胞肺癌 | Extensive-Stage Small-Cell Lung Cancer |
| 試験のタイプ / Study type | 介入 | Interventional |
| 試験デザイン / Study design | ||
| ランダム化 / Randomization | ||
| 介入1 | - 被験薬群：タルラタマブとデュルバルマブの併用投与 タルラタマブを2週間に1回（Q2W）、デュルバルマブを4週間に1回（Q4W）投与する。 Intervention： 薬剤：タルラタマブ 薬剤：デュルバルマブ - 実薬対照群：デュルバルマブのみ デュルバルマブをQ4W単剤投与する Intervention： 薬剤：デュルバルマブ | |
| 介入2 | - 被験薬群：タルラタマブとデュルバルマブの併用投与 タルラタマブを2週間に1回（Q2W）、デュルバルマブを4週間に1回（Q4W）投与する。 Intervention： 薬剤：タルラタマブ 薬剤：デュルバルマブ - 実薬対照群：デュルバルマブのみ デュルバルマブをQ4W単剤投与する Intervention： 薬剤：デュルバルマブ | |
| 介入3 | - 被験薬群：タルラタマブとデュルバルマブの併用投与 タルラタマブを2週間に1回（Q2W）、デュルバルマブを4週間に1回（Q4W）投与する。 Intervention： 薬剤：タルラタマブ 薬剤：デュルバルマブ - 実薬対照群：デュルバルマブのみ デュルバルマブをQ4W単剤投与する Intervention： 薬剤：デュルバルマブ | |
| 介入4 | - 被験薬群：タルラタマブとデュルバルマブの併用投与 タルラタマブを2週間に1回（Q2W）、デュルバルマブを4週間に1回（Q4W）投与する。 Intervention： 薬剤：タルラタマブ 薬剤：デュルバルマブ - 実薬対照群：デュルバルマブのみ デュルバルマブをQ4W単剤投与する Intervention： 薬剤：デュルバルマブ | |
| 介入5 | - 被験薬群：タルラタマブとデュルバルマブの併用投与 タルラタマブを2週間に1回（Q2W）、デュルバルマブを4週間に1回（Q4W）投与する。 Intervention： 薬剤：タルラタマブ 薬剤：デュルバルマブ - 実薬対照群：デュルバルマブのみ デュルバルマブをQ4W単剤投与する Intervention： 薬剤：デュルバルマブ | |
| 介入6 | - 被験薬群：タルラタマブとデュルバルマブの併用投与 タルラタマブを2週間に1回（Q2W）、デュルバルマブを4週間に1回（Q4W）投与する。 Intervention： 薬剤：タルラタマブ 薬剤：デュルバルマブ - 実薬対照群：デュルバルマブのみ デュルバルマブをQ4W単剤投与する Intervention： 薬剤：デュルバルマブ | |
| 主要評価項目 / Primary outcomes | 1. 全生存期間［最長約3年］ | 1. OS [Time Frame: Up to approximately 3 years] |
| 副次評価項目 / Secondary outcomes | 1. 無増悪生存期間（PFS）［最長約3年］ 2. 客観的奏効（OR）［最長約3年］ 3. 病勢コントロール（DC）率［最長約3年］ 4. 奏効期間（DoR）［最長約3年］ 5. 6カ月時点のPFS［6カ月］ 6. 1年時点のPFS［1年間］ 7. 2年時点のPFS［2年間］ 8. 6ヵ月時点のOS［6カ月］ 9. 1年時点のOS［1年間］ 10. 2年時点のOS［2年間］ 11. 3年時点のOS［3年間］ 12. 無増悪期間（TTP）［最長約3年］ 13. 試験治療下で発現した有害事象（TEAE）が認められた被験者数［最長約9カ月間］ 14. 有害事象共通用語規準（CTCAE）第5.0版に基づくGrade 3以上のTEAEが認められた被験者数［最長約3年］ 15. 重篤なTEAEが認められた被験者数［最長約3年］ 16. 治験薬の投与中止に至ったTEAEが認められた被験者数［最長約3年］ 17. 死亡に至ったTEAEが認められた被験者数［最長約3年］ 18. 治験薬と関連のある有害事象（AE）が認められた被験者数［最長約9カ月間］ 19. 注目すべき有害事象（EOI）が認められた被験者数［最長約9カ月間］ 20. 血清中タルラタマブ濃度［Day 1から約6カ月］ 21. 抗タルラタマブ抗体発現が認められた被験者数［最長約9カ月間］ 22. European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30（EORTC-QLQ-C30）により測定した身体機能の最初の悪化までの期間（TTD）［最長約9カ月間］ 23. EORTC-QLQ LC13を用いて測定した咳嗽の疾患症状の変化［最長12カ月まで］ 24. EORTC-QLQ LC13を用いて測定した胸痛の疾患症状の変化［最長12カ月まで］ 25. EORTC-QLQ LC13を用いて測定した呼吸困難の疾患症状の変化［最長12カ月まで］ 26. EORTC-QLQ-C30を用いて測定した全般的健康状態のTTD［最長約9カ月間］ 27. EORTC-QLQ-C30を用いて測定した生活の質のTTD［最長約9カ月間］ | 1. Progression Free Survival (PFS) [Time Frame: Up to approximately 3 years] 2. Overall Response (OR) [Time Frame: Up to approximately 3 years] 3. Disease Control (DC) Rate [Time Frame: Up to approximately 3 years] 4. Duration of Response (DoR) [Time Frame: Up to approximately 3 years] 5. PFS at 6 Months [Time Frame: 6 months] 6. PFS at 1 Year [Time Frame: 1 year] 7. PFS at 2 Years [Time Frame: 2 years] 8. OS at 6 Months [Time Frame: 6 months] 9. OS at 1 Year [Time Frame: 1 year] 10. OS at 2 Years [Time Frame: 2 years] 11. OS at 3 Years [Time Frame: 3 years] 12. Time to Progression (TTP) [Time Frame: Up to approximately 3 years] 13. Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 9 months] 14. Number of Participants with TEAEs Grade 3 or Above per Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. [Time Frame: Up to approximately 3 years] 15. Number of Participants with Serious TEAEs [Time Frame: Up to approximately 3 years] 16. Number of Participants with TEAEs Leading to Discontinuation of Treatment [Time Frame: Up to approximately 3 years] 17. Number of Participants with Fatal TEAEs [Time Frame: Up to approximately 3 years] 18. Number of Participants with Treatment-related Adverse Events (AEs) [Time Frame: Up to approximately 9 months] 19. Number of Participants with Adverse Events of Interest (EOI) [Time Frame: Up to approximately 9 months] 20. Serum Concentrations of Tarlatamab [Time Frame: Day 1 up to approximately 6 months] 21. Number of Participants with Antitarlatamab Antibody Formation [Time Frame: Up to approximately 9 months] 22. Time to First Deterioration (TTD) for Physical Function as Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC-QLQ-C30) [Time Frame: Up to approximately 9 months] 23. Change in Disease Symptoms of Cough as Measured Using EORTC-QLQ LC13 [Time Frame: Up to 12 months] 24. Change in Disease Symptoms of Chest Pain as Measured Using EORTC-QLQ LC13 [Time Frame: Up to 12 months] 25. Change in Disease Symptoms of Dyspnea as Measured Using EORTC-QLQ LC13 [Time Frame: Up to 12 months] 26. TTD for Global Health Status as Measured by EORTC-QLQ-C30 [Time Frame: Up to approximately 9 months] 27. TTD for Quality of Life as Measured by EORTC-QLQ-C30 [Time Frame: Up to approximately 9 months] |
適格性
| 年齢（下限）/ Age minimum | 18歳以上 | >= 18age old |
|---|---|---|
| 年齢（上限）/ Age maximum | Not applicable | |
| 性別 / Gender | 男女両方 | Both |
| 選択基準 / Include criteria | 1. Participant has provided informed consent prior to initiation of any study specific activities/procedures. 2. Age >= 18 years (or >= legal adult age within the country if it is older than 18 years). 3. Completed 3-4 cycles of platinum-etoposide chemotherapy with concurrent durvalumab as first-line treatment of extensive-stage (ES)-SCLC prior to enrollment, without disease progression (ongoing response or stable disease) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1). 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1. 5. Minimum life expectancy > 12 weeks. 6. Toxicities attributed to prior anti-cancer therapy resolved to grade <= 1, unless otherwise specified, excluding alopecia or fatigue. 7. Adequate organ function. 8. Histologically or cytologically documented extensive-stage disease (American Joint Committee on Cancer, 2017, IV small-cell lung cancer (SCLC) [T any, N any, M1 a/b/c]), or T3 to T4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. - Participants with prior limited-stage (LS)-SCLC are allowed if the interval is > 6 months since the end of previous therapy and progression, in discussion with the medical monitor. | |
| 除外基準 / Exclude criteria | 1. Symptomatic central nervous system (CNS) metastases, or leptomeningeal disease. Participants with treated brain metastases are eligible as per protocol. 2. Prior history of severe or life-threatening events from any immune-mediated therapy. 3. History of other malignancy within the past 2 years, with some exceptions as per protocol. 4. Active or prior documented autoimmune or inflammatory disorders as per protocol. 5. Myocardial infarction and/or symptomatic congestive heart failure (New York Heart Association > class II) within 6 months of first dose of study treatment. 6. History of arterial thrombosis (e.g., stroke or transient ischemic attack) within 6 months of first dose of study treatment. 7. Evidence of interstitial lung disease (ILD) or active, non-infectious pneumonitis. 8. History of solid organ transplant. 9. Major surgical procedures within 28 days of first dose of study treatment. 10. Known human immunodeficiency virus (HIV) infection (participants with HIV infection on antiviral therapy and undetectable viral load are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on study), hepatitis C infection (participants with hepatitis C that achieve a sustained virologic response after antiviral therapy are allowed), or hepatitis B infection (participants with hepatitis B surface antigen [HBsAg] or core antibody that achieve sustained virologic response with antiviral therapy are permitted with a requirement for regular monitoring for reactivation for the duration of treatment on the study). 11. Receiving systemic corticosteroid therapy or any other form of immunosuppressive therapy within 14 days prior to first dose of study treatment. 12. History of allergic reactions or acute hypersensitivity reaction to antibody therapies, platinum chemotherapy, or etoposide. 13. Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection within 7 days prior to the first dose of study treatment. 14. Participant has known active infection requiring parenteral antibiotic treatment. Upon completion of parenteral antibiotics and resolution of symptoms, the participant may be considered eligible for the study from an infection standpoint. 15. Treatment with live virus, including live-attenuated vaccination, within 4 weeks prior to the first dose of study treatment. Inactive vaccines (e.g., non-live or non-replicating agent) and live viral non-replicating vaccines (e.g., Jynneos for Monkeypox infection) within 30 days prior to first dose of study treatment. 16. Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3) pathway. 17. Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breast cancer is permitted. 18. Treatment in an alternative investigational trial within 28 days prior to enrollment. 19. Has received or is planning to receive consolidative chest radiation for extensive stage disease. 20. Female participants of childbearing potential unwilling to use protocol specified method of contraception during treatment as per protocol. 21. Female participants who are breastfeeding or who plan to breastfeed while on study as per protocol. 22. Female participants planning to become pregnant or donate eggs while on study as per protocol. 23. Female participants of childbearing potential with a positive pregnancy test assessed at screening by a highly sensitive serum pregnancy test. 24. Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment as per protocol. 25. Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment as per protocol. 26. Male participants unwilling to abstain from donating sperm during treatment as per protocol. 27. Participant has known sensitivity to any of the products or components to be administered during dosing. 28. History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or physician if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion. 29. Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the participant and investigator's knowledge. - Participants who are unable to complete clinical outcome assessments are eligible. |
責任研究者
| 責任研究者 / Name of lead principal investigator | Shuzo Tagashira | |
|---|---|---|
| 組織名 / Organization | ||
| 部署名 / Division | Amgen K.K. | |
| 住所 / Address | Midtown Tower 9-7-1 Akasaka, Minato-ku Tokyo Japan 107-6239 | |
| 電話 / Telephone | +81-80-7217-8592 | |
| 実施責任組織 / Affiliation | 田頭 秋三 | Amgen K.K. |
| 研究費提供組織 / Funding Source | ||
| 共同実施組織 / Funding Source | ||
| 受付ID |
試験問い合わせ窓口
| 住所 / Address | Midtown Tower 9-7-1 Akasaka, Minato-ku Tokyo Japan 107-6239 | |
|---|---|---|
| 電話 / Telephone | +81-80-7217-8592 | |
| ホームページURL | ||
| clinicaltrials_japan@amgen.com | ||
| 担当者 / Name of contact person | Contact Local |
倫理審査委員会
| 認定臨床研究審査委員会又は倫理審査委員会の名称 | ||
|---|---|---|
| 上記委員会の認定番号 | 住所 / Address | |
| 電話番号 | ||
| 審査受付番号 | ||
| 当該臨床研究に対する審査結果 | ||
| 認定臨床研究審査委員会の承認日 | ||
変更・中止の場合
| 中止届出日 | ||
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| 中止年月日 | ||
| 中止の理由 | ||
終了の場合
| 終了届出日 | ||
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| 観察期間終了日 | ||
| 実施症例数 | ||
| 参加者の流れ（Participant flow） | ||
| 研究対象者の背景情報 | ||
| 疾病等の発生状況のまとめ | ||
| 主要評価項目及び副次評価項目のデータ解析及び結果 | ||
| 公開予定日 | ||
| 要約 | ||
| 研究実施計画書のURL | ||
| 結果に関する最初の出版物での発表日 | ||
| 結果と出版物に関するURL | ||
IPD data sharing
| 個々の研究対象者単位のデータ（IPD）を共有する計画 | ||
|---|---|---|
| 計画の説明 | ||