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Checkpoint Inhibitor

Durvalumab + Tremelimumab for Non-Small Cell Lung Cancer (MYSTIC Trial)

Phase 3

Waitlist Available

Led By Naiyer Rizvi, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged at least 18 years

No sensitizing EGFR mutation or ALK rearrangement

Must not have

Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease]

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tumour scans performed at baseline then every 6 weeks up to week 48, then every 8 weeks thereafter until 1st progression. disease then assessed per local practice until 2nd progression. assessed up to data cut-off date (maximum of approximately 3 years).

Awards & highlights

Approved for 10 Other Conditions

No Placebo-Only Group

Pivotal Trial

Summary

This trial will study whether a combination of two immunotherapy drugs is more effective than standard chemotherapy in treating patients with a certain type of lung cancer.

Who is the study for?

This trial is for adults over 18 with Stage IV NSCLC without EGFR mutations or ALK rearrangements, who haven't had systemic therapy for recurrent/metastatic NSCLC. Ideal candidates have a good performance status (0 or 1). It's not for those with certain lung cancer types, brain metastases/spinal issues unless stable and untreated, autoimmune/inflammatory disorders, or prior immunomodulatory therapy.

What is being tested?

The study tests the effectiveness and safety of MEDI4736 (Durvalumab) alone and combined with Tremelimumab versus standard platinum-based chemotherapy in first-line treatment. Patients are randomly assigned to receive either the new therapies or one of several chemo options.

What are the potential side effects?

Possible side effects include immune-related reactions affecting organs, infusion-related symptoms, fatigue, gastrointestinal disturbances like colitis from Tremelimumab/Durvalumab. Chemotherapy may cause nausea, hair loss, blood cell count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer does not have EGFR mutations or ALK rearrangements.

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I haven't received any treatment for my recurrent or metastatic NSCLC.

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My condition is Stage IV non-small cell lung cancer.

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I can perform most of my daily activities without assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lung cancer is a mix of small-cell and non-small cell types.

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I have or had an autoimmune or inflammatory disorder like Crohn's disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumour scans performed at baseline then every 6 weeks up to week 48, then every 8 weeks thereafter until 1st progression. disease then assessed per local practice until 2nd progression. assessed up to data cut-off date (maximum of approximately 3 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumour scans performed at baseline then every 6 weeks up to week 48, then every 8 weeks thereafter until 1st progression. disease then assessed per local practice until 2nd progression. assessed up to data cut-off date (maximum of approximately 3 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumour scans performed at baseline then every 6 weeks up to week 48, then every 8 weeks thereafter until 1st progression. disease then assessed per local practice until 2nd progression. assessed up to data cut-off date (maximum of approximately 3 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Cmax_ss of Tremelimumab

Ctrough_ss of Tremelimumab

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