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Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (PrE0512)

2026년 6월 4일 업데이트: PrECOG, LLC.

Phase III Trial of Consolidation Tarlatamab + Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer (LS-SCLC)

Eligible participants with limited stage-small cell lung cancer (LS-SCLC) will be enrolled after completion of chemotherapy and radiation. Participants will be randomized to either tarlatamab in combination with durvalumab or durvalumab alone as consolidation therapy. Treatment will continue until disease progression, unacceptable side effects or withdrawal of consent.

Tarlatamab is a targeted cancer treatment. It works by acting as a matchmaker between the immune system's T-cells and the cancer cells, forcing them to come together so the T-cells can attack the cancer.

Image testing will be done standardly during treatment. These tests show whether the cancer has progressed and if further treatment may be needed.

The purpose of this trial is to evaluate how well the treatment works (how long before your cancer comes back and how long you live).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

The purpose of this trial is to evaluate the clinical efficacy of tarlatamab in combination with durvalumab as consolidation therapy for LS-SCLC after completion of chemotherapy and radiation compared to durvalumab alone. Tarlatamab has demonstrated significant clinical activity against SCLC in the extensive stage setting and demonstrated improved overall survival compared to second line chemotherapy. The durability of response and progression-free survival (PFS) rates are encouraging that this therapy has the ability to achieve more long-term disease control than traditional treatments like chemotherapy and programmed cell death-ligand 1 (PD-L1) immunotherapy alone. Given the high risk of recurrence and death for LS-SCLC, tarlatamab may be an effective strategy to improve the risk of recurrence and death in this earlier disease setting.

Tarlatamab is a bi-specific T-cell engager that targets delta-like ligand 3 (DLL3) and CD3 and was developed with the intent to treat small cell lung cancer due to the high level of expression of DLL3 on the cell surface. The anti-tumor activity of tarlatamab requires simultaneous binding to both target cells and T cells.

RECIST 1.1 criteria will be used for disease response. This is will be measured by the investigators as well as a Blinded Independent Central Review (BICR).

Archived tumor tissue will be requested at baseline for future research. Research peripheral blood samples will be obtained to measure the level of tarlatamab and for future research.

Patient-reported outcomes will also be performed.

연구 유형

중재적

등록 (추정된)

430

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

  • Patient must have histologically or cytologically confirmed Small Cell Lung Cancer (SCLC).

  • SCLC must be diagnosed as Limited-Stage-SCLC (LS-SCLC) (Stage I-III, disease can be encompassed within a radical radiation portal per investigator assessment) and treated with 3 to 4 cycles of chemotherapy and radiation therapy. Three cycles of chemotherapy will be acceptable if the planned radiation therapy course is completed concurrently with chemotherapy.

    • Patient must not be eligible for surgical resection or have had prior surgical resection for the current diagnosis of LS-SCLC.
    • Small cell carcinoma may not be transformed from previous diagnosis of non-small cell lung cancer (e.g., Epidermal Growth Factor Receptor (EGFR)-mutant non-small cell lung cancer (NSCLC) with SCLC transformation). Mixed histology (aka combined small cell) histology tumors are permitted if the majority component is small cell histology.
    • Chemotherapy must consist of a platinum agent (carboplatin or cisplatin) and etoposide.
    • Definitive radiation may include daily treatment ≥ 60 gray (Gy) or twice-daily treatments 45 Gy or other biologically equivalent regimens given concurrently with chemotherapy.
    • For early LS-SCLC (e.g., T1-2, N0, M0) without lymph node involvement, treatment with stereotactic ablative radiotherapy (SABR/SBRT) and chemotherapy is allowed.

    • Prophylactic cranial radiation (PCI) is permitted but not required. If PCI is administered, 7 day wash-out period is required before start of study treatment.

      • PCI consists of whole brain radiation therapy delivered in the absence of brain metastases. Hippocampal-sparing whole brain plans are considered PCI.
    • Patient must be able to be randomized and have planned cycle 1 day 1 treatment within 42 days of the last dose of thoracic radiation therapy or end of last cycle of chemotherapy, whichever was given most recently.
  • Completed chemotherapy and radiation with no evidence of progression of disease per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1 (i.e., achieved complete response, partial response, or stable disease), including no evidence of metastatic disease on brain MRI, after treatment but prior to randomization.
  • Patient must be ≥ 18 years of age.
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Patient must have the ability to understand and willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  • Patient must be willing to provide archived tumor tissue (if available) for research.

  • Patient must have adequate organ function and marrow function as defined below, obtained ≤ 14 days prior to randomization (Echocardiogram (ECHO)/Multi-Gated Acquisition (MUGA) ≤ 28 days).

    • Absolute Neutrophil Count (ANC) ≥ 1500/microliter (mcL)
    • Hemoglobin ≥ 8.0 g/dL
    • Platelets ˃100,000/mcL
    • Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5x upper limit normal (ULN) except for patients on stable dose anticoagulation for 6 weeks prior to randomization.
    • Activated partial thromboplastin Time (aPTT) ≤ 1.5x ULN except for patients on stable dose anticoagulation for 6 weeks prior to randomization.
    • Serum Creatinine ≤ 2x ULN
    • Creatinine clearance(CrCl) ≥ 30 mL/min
    • ALT (Alanine Aminotransferase) and AST (Aspartate Aminotransferase) ≤ 2.5x ULN
    • Total Bilirubin ≤ 1.5x ULN or ≤ 2x ULN for patients with documented Gilbert's disease
    • No evidence of human immunodeficiency virus (HIV) within 6 months of randomization.
    • Hepatitis B virus (HBV) and Hepatitis C virus (HCV) negative within 6 months of randomization.
    • Pulmonary Function: No oxygen supplementation
    • Electrocardiogram (ECG) with no findings of acute/subacute ischemia and/or clinically significant arrythmia
    • Cardiac Function: Cardiac ejection fraction ≥ 50% and no large or symptomatic pericardial effusion requiring intervention
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.
  • Patient must not expect to conceive, or father children by using an accepted and highly effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study, and for 90 days after the last dose of study drug(s). Also, patient must not expect to breastfeed, donate eggs, or donate sperm during study or for 90 days after the last dose of study drug(s).
  • Patient with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patient must not have had major surgery within 28 days, or minor surgery within 10 days, before randomization.
  • Patient must not have a history of clinically significant interstitial lung disease or active pneumonitis requiring steroid treatment. Patients with grade 1 radiation pneumonitis or fibrosis are permitted to enroll.
  • Patient with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification (NYHA Classification). To be eligible for this trial, patient must be class IIB or better.
  • Patients with history of autoimmune disorders are eligible to enroll only if no disease flares and not requiring any systemic immunosuppressive agents in the past 5 years. Topical or inhaled steroids are permitted. The following are not exclusionary: vitiligo, asthma, endocrine disorders that required only hormone replacement, psoriasis or other skin disorders that do not require systemic treatment, celiac disease controlled by diet alone.
  • Patients with active primary immunodeficiency are not permitted to enroll.
  • Prior history of severe or life-threatening events (Common Terminology Criteria for Adverse Events (CTCAE) V6.0 grade ≥ 3) from any immune-related therapy.
  • Patients with any condition requiring chronic oral corticosteroids is eligible if steroid dose is ≤ 10 mg/day prednisone equivalent. Physiologic replacement doses for adrenal insufficiency are permitted even if dose exceeds 10 mg/day. Inhaled corticosteroids and local steroid injections are permitted. All other uses of steroids must be tapered to ≤ 10 mg/day before randomization.
  • Patients must not have a history of allogeneic solid organ, allogeneic bone marrow or stem cell transplantation.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within for 6 months of before randomization are eligible for this trial.
  • Patient must not have received any live vaccine within 28 days prior to randomization.
  • Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.
  • Any prior therapy with a selective inhibitor of the DLL3 pathway is not permitted.
  • Any prior therapy with immune-mediated therapy including anti-CTLA-4, anti-PD-1, or anti PD-L1 is not permitted.
  • Receiving another anti-cancer therapy is not permitted except for hormonal therapy for breast or prostate cancer, topical therapies for cutaneous malignancies, or superficial treatments for non-muscle invasive bladder cancers.
  • Patients with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible.
  • Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm A: Tarlatamab in Combination with Durvalumab
Tarlatamab in combination with durvalumab. 1 cycle = 28 days.
의약품: Tarlatamab
Tarlatamab Intravenous (IV): Cycle 1 Step Dose: Day 1- 1 mg; Day 8- 10 mg; Day 15- 10 mg of a 28-day cycle, then Cycle 2 and Subsequent Cycles: Day 1- 10 mg and Day 15- 10 mg every 28-day cycle up to 12 months from cycle 1 day 1 unless other treatment discontinuation or rechallenge criteria are met.
다른 이름들:
  • AMG757
  • IMDELLTRA
의약품: Durvalumab
Durvalumab 1500 mg IV: Every 4 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months from cycle 1 day 1, unless other treatment discontinuation criteria are met.
다른 이름들:
  • 메디4736
  • 임핀지®
활성 비교기: Arm B: Durvalumab
Durvalumab only. 1 cycle = 28 days.
의약품: Durvalumab
Durvalumab 1500 mg IV: Every 4 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months from cycle 1 day 1, unless other treatment discontinuation criteria are met.
다른 이름들:
  • 메디4736
  • 임핀지®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).
기간: From randomization until death due to any cause, assessed up to 131 months.
The dual primary endpoints are PFS by Blinded Independent Central Review (BICR) and OS. OS is defined as time from randomization until death due to any cause.
From randomization until death due to any cause, assessed up to 131 months.
This phase III study has dual primary endpoints of progression-free survival (PFS) and overall survival (OS).
기간: From randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first, assessed up to 131 months.
The dual primary endpoints are PFS by Blinded Independent Central Review (BICR) and OS. PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first, in the absence of subsequent anticancer therapy. For participants with post-baseline imaging assessments, PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy or the earlier of the following, where applicable: (a) the last evaluable post-baseline tumor assessment prior to or on subsequent anticancer therapy, or (b) the last post-baseline assessment that precedes two or more consecutive missing/not evaluable assessments followed by disease progression or death. For participants with no post-baseline imaging assessments, PFS will be censored at the date of randomization.
From randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first, assessed up to 131 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Secondary endpoints include safety/tolerability.
기간: From treatment start to 90 (+5) days after their last dose of study medication.
Toxicity will be determined using the CTCAE V6.0. Toxicity will be assessed by summaries by CTCAE grade. Participants will be followed for adverse events for 90 (+5) days after their last dose of study medication. However, if a participant experiences an adverse event >90 (+5) days after their last dose of study medication that is felt to be, in the opinion of the investigator, possibly, probably or definitely related to study therapy, the adverse event should be reported.
From treatment start to 90 (+5) days after their last dose of study medication.
Secondary endpoints include investigator-assessed PFS.
기간: From randomization until the first documentation of investigator-assessed radiologic disease progression or death due to any cause, whichever occurs first, assessed up to 131 months.
Secondary objectives include to evaluate the difference in investigator-assessed PFS per RECIST 1.1 with tarlatamab + durvalumab as compared to durvalumab alone.
From randomization until the first documentation of investigator-assessed radiologic disease progression or death due to any cause, whichever occurs first, assessed up to 131 months.
Secondary endpoints 3 and 5-year PFS rate
기간: From randomization to 3 and 5 years after randomization.
3 and 5-year PFS is defined as the Kaplan-Meier-estimated probabilities of being alive and progression-free at 3 years and 5 years.
From randomization to 3 and 5 years after randomization.
Secondary endpoints include 3 and 5-year OS rate.
기간: From randomization to 3 and 5 years after randomization.
3 and 5-year OS is defined as the Kaplan-Meier-estimated probabilities of being alive at 3 years and 5 years.
From randomization to 3 and 5 years after randomization.
Secondary endpoints include cumulative incidence Central Nervous System (CNS) metastases.
기간: From randomization until last follow-up, assessed up to 131 months.
The BICR will conduct 2 assessments of tumor response using RECIST 1.1: one for the overall systemic disease (based on non-target and new lesions) and one solely for the evaluation of CNS endpoints (based on brain metastases only).
From randomization until last follow-up, assessed up to 131 months.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

PrECOG, LLC.

협력자

Amgen

수사관

  • 연구 의자: Ryan Gentzler, MD, MS, University of Virginia

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2027년 1월 1일

기본 완료 (추정된)

2037년 11월 1일

연구 완료 (추정된)

2038년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 19일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 4일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PrE0512
  • Amgen 20240331 (기타 식별자: Amgen)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Data is proprietary

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

제한된 단계 소형 세포 폐암에 대한 임상 시험

Tarlatamab에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Azerbaijan

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다