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).

Official Title

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)

Summary:

This is a randomized, open-label, multi-centre, global, Phase III study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy versus platinum-based SoC chemotherapy in the first-line treatment of patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild-type locally advanced or metastatic NSCLC

Trial Description

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.

View this trial on ClinicalTrials.gov