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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
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

MYSTIC 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.Check my eligibility
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.See study design
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.

MYSTIC Trial 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.

MYSTIC Trial 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).
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
+24 more

Side effects data

From 2019 Phase 2 trial • 33 Patients • NCT03007407
38%
Fatigue
21%
Diarrhea
17%
Pruritus
17%
Maculopapular rash
17%
Anorexia
17%
Nausea
17%
Fever
14%
Rash maculo-papular
14%
Constipation
10%
Itching
10%
Anemia
10%
Abdominal pain
7%
Cough
7%
Dry Skin
7%
Dehydration
7%
Hypothyroidism
7%
Non-cardiac chest pain
7%
Weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab and Tremelimumab

MYSTIC Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: MonotherapyExperimental Treatment1 Intervention
PD-L1 monoclonal Antibody monotherapy.
Group II: Combination TherapyExperimental Treatment2 Interventions
PD-L1+Tremelimumab combination therapy
Group III: Standard of CareActive Control5 Interventions
Standard of Care chemotherapy treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved
Tremelimumab
Not yet FDA approved

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,237 Previous Clinical Trials
288,448,557 Total Patients Enrolled
Naiyer Rizvi, MDPrincipal InvestigatorColumbia University Medical Center, New York, NY, USA
11 Previous Clinical Trials
180 Total Patients Enrolled
Stuart McIntosh, MDStudy DirectorAstraZeneca, Alderley Park, Cheshire, UK

Media Library

MEDI4736 (Durvalumab) (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02453282 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Monotherapy, Combination Therapy, Standard of Care
Non-Small Cell Lung Cancer Clinical Trial 2023: MEDI4736 (Durvalumab) Highlights & Side Effects. Trial Name: NCT02453282 — Phase 3
MEDI4736 (Durvalumab) (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02453282 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the common reasons that doctors prescribe Tremelimumab?

"While often used to treat advance directives, tremelimumab has also been found effective against fallopian tubes cancer, disease, and refractory testicular germ cell cancer."

Answered by AI

Are there any dangers in using Tremelimumab?

"Tremelimumab has received a score of 3 for safety. This is because it has progressed to Phase 3 clinical trials, which suggests that not only is the medication effective, but also that there is significant data supporting its safety."

Answered by AI

Could I possibly qualify to take part in this research project?

"Carcinoma patients that are non-small-cell lung cancer patients and between 18 and 130 years old can be accepted into this study. The clinical trial is enrolling around 1118 patients in total."

Answered by AI

Are people currently being recruited to participate in this experiment?

"According to the latest update on clinicaltrials.gov, this particular trial is not currently looking for patients. The study was first posted on July 21st, 2015 but has not been updated since September 29th, 2022. There are 3482 other trials that are presently recruiting patients."

Answered by AI

Does this research project have an age limit for participants?

"According to the study's requirements, patients must be aged 18-130 in order to participate. There are a total of 140 trials for people under 18 and 3408 for senior citizens."

Answered by AI

Do we have any previous experience with Tremelimumab?

"Tremelimumab was first studied in 1997 at City of Hope Comprehensive Cancer Center. So far, there have been a total of 2761 completed clinical trials. As of now, 1923 clinical trials are actively recruiting with many of these taking place in Pembroke Pines, Florida."

Answered by AI

In how many different countries is this research being conducted?

"Presently, the study is being conducted at 42 different sites. While Pembroke Pines, Honolulu and New york are a few of these locations, there are also other centres in close proximity. If you elect to participate in this clinical trial, it is best to choose a location that is convenient for you to reduce travel time and costs."

Answered by AI

How many people have been recruited for this experiment?

"Unfortunately, this study is not currently recruiting patients. Although, it's important to note that the trial was last updated on September 29th, 2022 and was originally posted on July 21st, 2015. If you're interested in other studies, there are 1559 clinical trials for carcinoma, non-small-cell lung and 1923 Tremelimumab trials that are presently admitting patients."

Answered by AI

What is the primary goal of this clinical trial?

"The primary objective of this study is to evaluate the progression-free survival (PFS) of patients treated with durvalumab and tremelimumab, compared to those receiving standard of care chemotherapy. Secondary objectives include determining the trough concentration (Ctrough_ss) of tremelimumab, PFS in the Fatel Association for cancer Research International biomarker population, and overall response rate (ORR) in the programmed cell death ligand 1 (PD-L1) analysis set population."

Answered by AI
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~116 spots leftby Mar 2025