Overview

This trial is active, not recruiting.

Condition non-small-cell lung carcinoma (nsclc)
Treatments medi4736 (durvalumab), medi4736 (durvalumab)+tremelimumab, paclitaxel + carboplatin, gemcitabine + cisplatin, gemcitabine + carboplatin, pemetrexed + cisplatin, pemetrexed + carboplatin, tremelimumab
Phase phase 3
Targets CTLA-4, PD-1
Sponsor AstraZeneca
Start date July 2015
End date January 2017
Trial size 1092 participants
Trial identifier NCT02453282, D419AC00001

Summary

This is a randomized, open-label, multi-center, 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

United States California
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
PD-L1 monoclonal Antibody monotherapy.
medi4736 (durvalumab)
(Experimental)
PD-L1+Tremelimumab combination therapy
medi4736 (durvalumab)+tremelimumab
tremelimumab
(Active Comparator)
Standard of Care chemotherapy treatment
paclitaxel + carboplatin Platinum based Standard of Care Chemotherapy
Chemotherapy Agents
gemcitabine + cisplatin Platinum based Standard of Care Chemotherapy
Chemotherapy Agents
gemcitabine + carboplatin Platinum based Standard of Care Chemotherapy
Chemotherapy Agents
pemetrexed + cisplatin Platinum based Standard of Care Chemotherapy
Chemotherapy Agents
pemetrexed + carboplatin Platinum based Standard of Care Chemotherapy
Chemotherapy Agents

Primary Outcomes

Measure
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of progression-free survival (PFS) and Overall Survival (OS) in patients with NSCLC
time frame: 3 years

Secondary Outcomes

Measure
The efficacy of MEDI4736 monotherapy compared to SoC in terms of progression free survival (PFS)
time frame: 3 years
Health related quality of life (HRQoL) in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)and QLQ-LC13
time frame: 3 years
The pharmacokinetics (PK) of MEDI4736 + tremelimumab combination therapy and MEDI4736 monotherapy
time frame: up to 6 months
The immunogenicity of MEDI4736 and tremelimumab
time frame: 3 years
The efficacy of MEDI4736 + tremelimumab combination therapy compared to SoC in terms of Objective Response Rate (ORR)
time frame: 3 years
The efficacy of MEDI4736 monotherapy compared to SoC in terms of Objective Response Rate (ORR)
time frame: 3 years
The efficacy of MEDI4736 monotherapy compared to SoC in terms of Overall Survival (OS)
time frame: 3 years
Disease-related symptoms and HRQoL in patients treated with MEDI4736 + tremelimumab or MEDI4736 compared to SoC using the European Organization for Research and Treatment of Cancer Quality of LifeQuestionnaire - Lung Cancer 13 items (EORTC QLQ-LC13).
time frame: 3 years

Eligibility Criteria

Male or female participants from 18 years up to 130 years old.

Inclusion Criteria: For inclusion in the study, patients should fulfill the following criteria: - Aged at least 18 years - Documented evidence of Stage IV NSCLC - No sensitizing EGFR mutation or ALK rearrangement - No prior chemotherapy or any other systemic therapy for recurrent/metastatic NSCLC - World Health Organization (WHO) Performance Status of 0 or 1 Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: 1. Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant 2. Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) 3. Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]

Additional Information

Official title A Phase III Randomized, Open-Label, Multi-Center, 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)
Principal investigator Naiyer Rizvi, MD
Description 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. The primary objectives of this study are: • To assess the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of PFS (Progression Free Survival) and OS (Overall Survival) in patients with NSCLC
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.