A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab Versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD-(L)1 Therapy and Platinum-based Chemotherapy: LATIFY - LATIFY

Astra Zeneca0 个研究点目标入组 19 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 19

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 64（—）

入选标准

•1 Participant must be >= 18 years at the time of screening.
•2 Histologically or cytologically documented NSCLC that is locally advanced or
•metastatic according to Version 8 of the IASLC Staging Manual in Thoracic
•Oncology, at the time of study enrolment. Participants with unknown status are
•not allowed onto the study. Note: A computed tomography or magnetic resonance
•imaging scan of the brain at baseline is required for all subjects.
•3 Where available, a tissue sample obtained after progression on prior
•anti-PD-(L)1 therapy and <= 3 months prior to randomisation should be provided.
•Where no such sample is available a tumour sample taken <= 24 months prior to
•screening is acceptable. Samples should be of sufficient quality to enable
•assessment of tumour cell PD-L1 expression. Tumour sample must be FFPE, with
•sufficient material for sectioning preferably 16 slides (5 micron thickness).
•If FFPE blocks cannot be provided, then a set of newly cut unstained slides
•that enable necessary testing should be provided (preferably a minimum of 16
•slides). Refer to Section 8.6.1 and the Laboratory Manual for details.
•4 Documented tumour cell PD-L1 status as assessed by a central laboratory using
•the VENTANA SP263 PD-L1 IHC assay prior to randomisation. Participants with
•unknown PD L1 status are not eligible for study.
•5 Documented EGFR and ALK wild-type status as determined at a local laboratory
•using a well validated, locally approved test. Participants with sensitising
•EGFR mutations (eg, exon 19 deletion; exon 21 L858R or L861Q; exon 18 G719X; or
•exon 20 insertion or S768I mutation) or ALK rearrangements are excluded from
•6 Tumours harbouring mutations in any of the following genes, if known, as
•determined by existing local test results: ROS1, RET, MET, BRAF V600, NTRK1 and
•NTRK2 are excluded.
•7 Documented radiological PD whilst on or after receiving the most recent
•treatment regimen.
•8 Eligible for second- or third-line therapy and must have received an
•anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally
•advanced or metastatic NSCLC either separately or in combination. Prior
•durvalumab is acceptable. Refer to exclusion criterion 16 for the requirements
•for prior anti-PD-(L)1 therapy.
•9 Received a minimum of 8 weeks of an anti-PD-(L)1 and at least 2 cycles of
•platinum doublet containing regimen for locally advanced or metastatic NSCLC
•(either separately or in combination).
•10 Participant must have had a treatment-free interval of >=4 weeks from any
•prior therapy before the start of study intervention. In addition, the
•following intervals between the end of the prior treatment and first dose of
•study intervention must be observed:
•(a) Minor surgical procedures (as defined by the investigator): 7
•post-operative days
•(b) Major surgery (as defined by the investigator): >= 4 weeks
•(c) Radiotherapy: >= 4 weeks (participants who receive palliative radiation for
•non-target tumour lesions need not be subjected to this washout period and can
•be enrolled immediately).
•11 ECOG/WHO performance status of 0 or 1 with no deterioration over the
•previous 2 weeks prior to baseline or day of first dosing.
•At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL
•at baseline and can be accurately measured at baseline as >= 10 mm in

排除标准

•1 Participant with mixed SCLC and NSCLC histology.
•2 As judged by the investigator, any evidence of diseases (such as severe or
•uncontrolled systemic diseases, including uncontrolled hypertension, active
•bleeding diseases, active infection, active interstitial lung
•disease/pneumonitis, serious chronic gastrointestinal conditions associated
•with diarrhoea, psychiatric illness/social situations), history of allogenic
•organ transplant, which, in the investigator*s opinion, makes it undesirable
•for the participant to participate in the study or that would jeopardise
•compliance with the protocol.
•3 Refractory nausea and vomiting, chronic gastrointestinal disease, inability
•to swallow a formulated product, or previous significant bowel resection that
•would preclude adequate absorption, distribution, metabolism, or excretion of
•ceralasertib.
•4 History of another primary malignancy except for malignancy treated with
•curative intent with no known active disease >= 5 years before the first dose of
•study intervention and of low potential risk for recurrence, basal cell
•carcinoma of the skin, squamous cell carcinoma of the skin or lentigo maligna
•that has undergone potentially curative therapy or adequately treated carcinoma
•in situ without evidence of disease.
•5 Brain metastases or spinal cord compression unless the participant is stable
•(asymptomatic, no evidence of new or emerging brain metastases) and off
•steroids for at least 14 days prior to start of study treatment. Following
•radiotherapy and/or surgery, participants with brain metastases must wait 4
•weeks following the intervention and must confirm stability with imaging before
•randomisation.
•6 Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer
•therapy; alopecia and vitiligo are excluded toxicities. Participants with Grade
•>= 2 neuropathy will be evaluated on a case by-case basis after consultation
•with the study clinical lead. Participants with irreversible toxicity that is
•not reasonably expected to be exacerbated by study interventions may be
•included (eg, hearing loss) after consultation with the AstraZeneca study
•clinical lead.
•7 History of ILD/pneumonitis (non-infectious) that required management with
•8 Active or prior documented autoimmune or inflammatory disorders (including
•inflammatory bowel disease [eg, colitis or Crohn*s disease], diverticulitis
•[with the exception of diverticulosis], systemic lupus erythematosus,
•sarcoidosis, granulomatosis with polyangiitis, Graves* disease, rheumatoid
•arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis and autoimmune
•myocarditis). The following are exceptions to this criterion:
•(a) Participants with vitiligo or alopecia
•(b) Participants with hypothyroidism (eg, following Hashimoto syndrome) stable
•on hormone replacement
•(c) Any chronic skin condition that does not require systemic therapy
•(d) Participants without active disease in the last 5 years may be included but
•only after consultation with the study physician
•(e) Participants with celiac disease controlled by diet alone
•9 History of leptomeningeal carcinomatosis.
•10 Known active hepatitis infection, positive HCV antibody, HBsAg or anti-HBc
•at screening. Participants with a past or resolved HBV infection (defined as
•the presence of anti HBc and absence of HBsAg)

研究者

发起方

Astra Zeneca

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