Study of MEDI4736 with or without Tremelimumab Versus standard of care chemotherapy in lung cancer (MYSTIC Study)

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) - MYSTIC

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001279-39-BE

Enrollment

1092

Registered

2015-09-25

Start date

2015-11-30

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naiive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumour pathology. MedDRA version: 20.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 100000004864

Interventions

Product Name: MEDI4736 Product Code: MEDI4736 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: durvalumab CAS Number: 1428935-60-7 Current Sponsor code: MEDI4736 Other d

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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 • Tumor PD-L1 status, with the Ventana SP263 PD-L1 IHC assay confirmed by a reference laboratory, must be known prior to randomization. • No prior chemotherapy or any other systemic therapy for advanced/metastatic NSCLC • World Health Organization (WHO) Performance Status of 0 or 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 732 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360

Exclusion criteria

Exclusion criteria: - Exclusion Criteria: Patients should not enter the study if any of the following exclusion criteria are fulfilled: • 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 inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)

Design outcomes

Primary

Measure	Time frame
Main Objective: - the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of PFS and OS in patients with NSCLC. - the efficacy of durvalumab therapy compared to SoC in terms of OS in patients with NSCLC N = 1092;Secondary Objective: To assess the efficacy of durvalumab monotherapy and durvalumab + tremelimumab combination therapy in terms of PFS, OS and ORR compared to SoC ;Primary end point(s): PFS using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1 Overall Survival (OS) ;Timepoint(s) of evaluation of this end point: At baseline, after that every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression. Assessments for survival every 2 months following treatment discontinuation	—

Measure

Time frame

Main Objective: - the efficacy of durvalumab + tremelimumab combination therapy compared to SoC in terms of PFS and OS in patients with NSCLC. - the efficacy of durvalumab therapy compared to SoC in terms of OS in patients with NSCLC N = 1092;Secondary Objective: To assess the efficacy of durvalumab monotherapy and durvalumab + tremelimumab combination therapy in terms of PFS, OS and ORR compared to SoC ;Primary end point(s): PFS using Blinded Independent Central Review (BICR) assessments according to RECIST 1.1 Overall Survival (OS) ;Timepoint(s) of evaluation of this end point: At baseline, after that every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression. Assessments for survival every 2 months following treatment discontinuation

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Secondary

Measure	Time frame
Secondary end point(s): The efficacy of Durvalumab monotherapy compared to SoC in terms of ORR or PFS The efficacy of Durvalumab + tremelimumab combination therapy compared to SoC in terms of ORR ;Timepoint(s) of evaluation of this end point: For PFS - At baseline, then every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression. Assessments for survival every 2 months following treatment discontinuation.	—

Measure

Time frame

Secondary end point(s): The efficacy of Durvalumab monotherapy compared to SoC in terms of ORR or PFS The efficacy of Durvalumab + tremelimumab combination therapy compared to SoC in terms of ORR ;Timepoint(s) of evaluation of this end point: For PFS - At baseline, then every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression. Assessments for survival every 2 months following treatment discontinuation.

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Countries

Australia, Belgium, Canada, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Spain, Taiwan, Thailand, United States, Vietnam

Contacts

Public ContactInformation Center

AstraZeneca AB

informationcenter@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026