Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)

Официальное название

A Multicenter Phase II Trial of Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in Homologous Recombination Deficiency (HRD) Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)

Обзор

Maintenance durvalumab (MEDI4736) and olaparib (AZD2281) after standard 1st line treatment (carboplatin/ cisplatin, etoposide, durvalumab) in HRD positive extensive disease (ED) small-cell lung cancer (SCLC)

Вмешательства

• Препарат Durvalumab
  1500 mg i.v. Q4W
• Препарат Olaparib
  300 mg BID orally

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Approximately two years (from First patient in (FSI) to Last patient last visit (LSLV))]

Вторичные конечные точки (2)

• Incidence, severity and grading of adverse events (AE) and seriouse adverse events (SAE). [Срок оценки: Approximately two years (from FSI to LSLV)]
• ORR of maintenance. [Срок оценки: Approximately two years (from FSI to LSLV)]

Критерии участия

Inclusion Criteria Pre-Screening:

• Newly diagnosed, histologically documented advanced or metastatic small-cell lung cancer (UICC stage III which is not amenable to curative radiochemotherapy or stage IV). \[...\]
• Either de novo biopsies collected as part of routine clinical practice or archival tumor samples (taken ≤6 months prior to screening) are acceptable.
• Planned or ongoing treatment with carboplatin/cisplatin, etoposide, durvalumab as 1st-line SoC. Pre-screening must begin no later than the start of the 3rd cycle to allow sufficient time for molecular analyses. \[...\]
• Available radiographic chest and abdominal CT or MRI scans performed up to 42 days before initial first line treatment with carboplatin/cisplatin, etoposide and durvalumab.
• At least one measurable site of disease as defined by RECIST v1.1 criteria.
• \[...\]

Inclusion Criteria Screening:

• Completed pre-screening with fulfillment of all inclusion and exclusion criteria of pre-screening. Pre-screening must have tested positive for homologous recombination deficiency as defined in this protocol at central testing. \[...\]
• Patients must not have radiographic or clinic disease progression while on induction therapy and/or prior to start of study treatment.
• Patients must have received 4 cycles (21-day cycles) of induction with carboplatin or cisplatin, etoposide and durvalumab completed within 1 to 14 days prior to initiation of study treatment on C5D1. Patients must have received durvalumab at minimum three times during the four induction cycles.
• Adequate organ and marrow function

Exclusion Criteria Pre-Screening:

• Induction therapy other than carboplatin/cisplatin, etoposide and durvalumab. (The administration of one induction cycle without durvalumab is permitted.)
• Radiographic or clinical evidence of progressive disease.
• Negative HRD result in a previous pre-screening in this trial.
• \[...\]

Exclusion Criteria Screening:

• Patients with symptomatic uncontrolled central nervous system (CNS) metastases.
• Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
• History of leptomeningeal carcinomatosis.
• Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy. Exceptions are:

• Alopecia (any Grade)
• Vitiligo (any Grade)
• Hypothyroidism stable on hormone replacement (Grade ≤2)
• Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or olaparib may be included only after consultation with the Sponsor.
• ...

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Hospital Cologne — Cologne

Идентификаторы

NCT: NCT06419179 · Uni-Koeln-5159 · 2024-512373-27-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗