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Clinical Trials List

Protocol NumberD533BC00001
NCT Number(ClinicalTrials.gov Identfier)NCT05450692
Active

2023-01-30 - 2026-04-24

Phase III

Not yet recruiting8

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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

  • Trial Applicant

    PAREXEL INTERNATIONAL CO., LTD.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Gee-chen Chang Division of Thoracic Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Te-Chun Hsia Division of General Internal Medicine
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Ying Liu Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
National Taiwan University Hospital Yunlin Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Advanced or Metastatic Non-Small Cell Lung Cancer

Objectives

main purpose To demonstrate the superiority of ceralasertib plus durvalumab over docetaxel by evaluating OS in participants with advanced NSCLC without treatable genomic alterations who had received second- or third-line therapy. secondary purpose ‧ To demonstrate the superiority of ceralasertib plus durvalumab over docetaxel by evaluating PFS ‧ Estimating the effectiveness of ceralasertib plus durvalumab combination therapy relative to docetaxel by evaluating ORR ‧ Estimating the effectiveness of combination therapy with ceralasertib plus durvalumab relative to docetaxel by assessing duration of response (DoR) ‧ Estimating the effectiveness of ceralasertib plus durvalumab relative to docetaxel by assessing time to response (TTR) ‧ Estimating the effectiveness of the combination of ceralasertib plus durvalumab relative to docetaxel by evaluating the disease control rate (DCR) at 18 weeks ‧ Estimating the effectiveness of ceralasertib plus durvalumab relative to docetaxel by assessing the time to second exacerbation or death (PFS2) ‧ Estimating the effectiveness of ceralasertib plus durvalumab versus docetaxel by evaluating OS at 12 months (OS12) ‧ Assess participant-reported health-related quality of life (QoL) ‧ Assessment of participant-reported physiological function in participants who received ceralasertib plus durvalumab versus docetaxel ‧ Assess participants’ reported treatment tolerance ‧ To evaluate the pharmacokinetics (PK) of ceralasertib when coadministered with durvalumab ‧ To evaluate the safety and tolerability of ceralasertib plus durvalumab compared with docetaxel

Test Drug

Ceralasertib (AZD6738)Durvalumab (MEDI4736)

Active Ingredient

Ceralasertib
Durvalumab

Dosage Form

Tablet
Concentrate solution for infusion

Dosage

80 mg, 120 mg
50 mg/mL

Endpoints

OS was defined as the period from random assignment to the date of death from any cause.

Comparisons will include all participants who received random assignment, regardless of whether the participant discontinued the randomly assigned treatment or received another
Anticancer therapy.

The metric of interest was the hazard ratio (HR) of OS.

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
Documented epidermal growth receptor factor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type status as determined at a local laboratory.
Documented radiological PD whilst on or after receiving the most recent treatment regimen.
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.
Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status of 0 or 1.
Adequate organ function and marrow reserve
Minimum life expectancy of 12 weeks.
Body weight > 30 kg and no cancer-associated cachexia.
Negative pregnancy test (serum test) for women of childbearing potential (WOCBP).

Exclusion Criteria

Exclusion Criteria:

Participant with mixed SCLC and NSCLC histology.
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.
Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
Active or prior documented autoimmune or inflammatory disorders.
Participants who have received more than one line of prior anti-PD-(L)1, either alone or in any combination.
Participants:

Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
Must not have experienced a Grade ≥ 3 immune-mediated adverse event (imAE) or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1 therapy.
Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day.
Participants who have received more than one prior line of platinum-based chemotherapy in metastatic setting.
Participants who have received a prior ataxia telangiectasia and Rad3-related protein (ATR) inhibitor.

The Estimated Number of Participants

  • Taiwan

    19 participants

  • Global

    580 participants

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