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) (MYSTIC)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

Conditions: Non-Small-Cell Lung Carcinoma NSCLC

Treatments: Drug: Paclitaxel + Carboplatin; Biological: MEDI4736 (Durvalumab); Drug: Pemetrexed + Carboplatin; Drug: Pemetrexed + Cisplatin; Biological: MEDI4736 (Durvalumab)+Tremelimumab; Biological: Tremelimumab; Drug: Gemcitabine + Carboplatin; Drug: Gemcitabine + Cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02453282

D419AC00001

2015-001279-39 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,118 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,118 participants in 3 patient groups

Monotherapy

Experimental group

Description:

PD-L1 monoclonal Antibody monotherapy.

Treatment:

Biological: MEDI4736 (Durvalumab)

Combination Therapy

Experimental group

Description:

PD-L1+Tremelimumab combination therapy

Treatment:

Biological: Tremelimumab

Biological: MEDI4736 (Durvalumab)+Tremelimumab

Standard of Care

Active Comparator group

Description:

Standard of Care chemotherapy treatment

Treatment:

Drug: Gemcitabine + Carboplatin

Drug: Gemcitabine + Cisplatin

Drug: Pemetrexed + Carboplatin

Drug: Pemetrexed + Cisplatin

Drug: Paclitaxel + Carboplatin