Informations générales (source: ClinicalTrials.gov)
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)
Interventional
Phase 3
AstraZeneca (Voir sur ClinicalTrials)
septembre 2022
août 2025
03 octobre 2024
This study will assess the efficacy and safety of the combination of ceralasertib and
durvalumab versus standard of care docetaxel in patients with locally advanced and
metastatic NSCLC after progression on prior anti-PD-(L)1 therapy and platinum-based
chemotherapy.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Jean Bernard AULIAC | 06/06/2024 11:27:16 | Contacter | ||
| CLCC INSTITUT GUSTAVE ROUSSY | Benjamin BESSE | 18/03/2024 11:06:10 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Research Site - 02321 - Saint-Quentin cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 33604 - Pessac - France | Contact (sur clinicalTrials) | ||||
| Research Site - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44093 - Nantes cedex 1 - France | Contact (sur clinicalTrials) | ||||
| Research Site - 44805 - Saint Herblain Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 49933 - Angers - France | Contact (sur clinicalTrials) | ||||
| Research Site - 57070 - Vantoux - France | Contact (sur clinicalTrials) | ||||
| Research Site - 63011 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Research Site - 69655 - Villefranche Sur Saone - France | Contact (sur clinicalTrials) | ||||
| Research Site - 75014 - Paris - France | Contact (sur clinicalTrials) | ||||
| Research Site - 92140 - Clamart Cedex - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94010 - Creteil - France | Contact (sur clinicalTrials) | ||||
| Research Site - 94805 - Villejuif Cedex - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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).
- 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).
- 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:
1. Must not have experienced a toxicity that led to permanent discontinuation of
the prior anti-PD(L)1 therapy.
2. All AEs while receiving prior anti-PD(L)1 therapy must have completely
resolved.
3. 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.
4. 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.