MYSTIC

A Phase 3 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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223013

Enrollment

Registered

2015-11-12

Start date

2015-12-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Small-Cell Lung Carcinoma (NSCLC)

Interventions

investigational material(s) Generic name etc : MEDI4736(Durvalumab), MEDI4736(Durvalumab)+Tremelimumab, Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin, Pemetrexed + Cispl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria: - Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant - Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids) - 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 - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory pharmacogenomics -	—

Secondary

Measure	Time frame
safety efficacy confirmatory exploratory pharmacokinetics pharmacogenomics -	—

Countries

Asia except Japan, Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026