Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC).

Titre officiel

A Phase III Randomized, Open-Label, Multi-Centre, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)

Sommaire:

Une étude multicentrique globale de phase III à répartition aléatoire, en mode ouvert visant à évaluer l'efficacité et l'innocuité de l'association médicamenteuse MEDI4736-tremelimumab et de MEDI4736 en monothérapie comparativement à une chimiothérapie traditionnelle de première intention à base de platine chez des patients atteints d'un CPNPC localement avancé ou métastatique comprenant la mutation du gène du récepteur du facteur de croissance épidermique (R-EGF) et le gène de fusion du lymphome anaplasique (ALK)

Description de l'essai

Primary Outcome:

• Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy
• Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy

Secondary Outcome:

• OS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
• OS; PD-L1 (TC >=1%) Analysis Set Population
• OS; FAS Population
• PFS; PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs Durvalumab Monotherapy
• PFS; PD-L1 (TC >=1%) Analysis Set Population
• PFS; FAS Population
• Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population
• ORR; PD-L1 (TC >=1%) Analysis Set Population
• ORR; FAS Population
• Duration of Response (DoR); PD-L1 (TC >=25%) Analysis Set Population
• DoR; PD-L1 (TC >=1%) Analysis Set Population
• DoR; FAS Population
• Percentage of Participants Alive and Progression Free at 12 Months (APF12); PD-L1 (TC >=25%) Analysis Set Population
• Percentage of Participants APF12; PD-L1 (TC >=1%) Analysis Set Population
• Percentage of Participants APF12; FAS Population
• Time From Randomization to Second Progression (PFS2); PD-L1 (TC >=25%) Analysis Set Population
• PFS2; PD-L1 (TC >=1%) Analysis Set Population
• PFS2; FAS Population
• Change From Baseline in Disease-Related Symptoms as Assessed by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaires (EORTC QLQ) at 12 Months
• Serum Concentrations of Durvalumab
• Serum Concentrations of Tremelimumab
• Maximum Serum Concentration at Steady State (Cmax_ss) of Durvalumab
• Cmax_ss of Tremelimumab
• Trough Serum Concentration at Steady State (Ctrough_ss) of Durvalumab
• Ctrough_ss of Tremelimumab
• Number of Participants With Anti-Drug Antibody (ADA) Response to Durvalumab
• Number of Participants With ADA Response to Tremelimumab

Patients will be randomized in a 1:1:1 ratio to receive treatment with MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy, or Standard of Care (SoC) therapy.

Voir cet essai sur ClinicalTrials.gov