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)

Launched by UNIVERSITY OF COLOGNE · May 16, 2024

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ALL

Eligibility criteria

• 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:
• • 1. Alopecia (any Grade)
• • 2. Vitiligo (any Grade)
• • 3. Hypothyroidism stable on hormone replacement (Grade ≤2)
• • 4. Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician
• • 5. 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.
• • 6. ...