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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)

NCT ID: NCT02453282

Last Updated: 2025-09-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-21

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Non-Small-Cell Lung Carcinoma NSCLC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monotherapy

PD-L1 monoclonal Antibody monotherapy.

Group Type EXPERIMENTAL

MEDI4736 (Durvalumab)

Intervention Type BIOLOGICAL

Combination Therapy

PD-L1+Tremelimumab combination therapy

Group Type EXPERIMENTAL

MEDI4736 (Durvalumab)+Tremelimumab

Intervention Type BIOLOGICAL

Tremelimumab

Intervention Type BIOLOGICAL

Standard of Care

Standard of Care chemotherapy treatment

Group Type ACTIVE_COMPARATOR

Paclitaxel + Carboplatin

Intervention Type DRUG

Chemotherapy Agents

Gemcitabine + Cisplatin

Intervention Type DRUG

Chemotherapy Agents

Gemcitabine + Carboplatin

Intervention Type DRUG

Chemotherapy Agents

Pemetrexed + Cisplatin

Intervention Type DRUG

Chemotherapy Agents

Pemetrexed + Carboplatin

Intervention Type DRUG

Chemotherapy Agents

Interventions

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MEDI4736 (Durvalumab)

Intervention Type BIOLOGICAL

MEDI4736 (Durvalumab)+Tremelimumab

Intervention Type BIOLOGICAL

Paclitaxel + Carboplatin

Chemotherapy Agents

Intervention Type DRUG

Gemcitabine + Cisplatin

Chemotherapy Agents

Intervention Type DRUG

Gemcitabine + Carboplatin

Chemotherapy Agents

Intervention Type DRUG

Pemetrexed + Cisplatin

Chemotherapy Agents

Intervention Type DRUG

Pemetrexed + Carboplatin

Chemotherapy Agents

Intervention Type DRUG

Tremelimumab

Intervention Type BIOLOGICAL

Other Intervention Names

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Platinum based Standard of Care Chemotherapy Platinum based Standard of Care Chemotherapy Platinum based Standard of Care Chemotherapy Platinum based Standard of Care Chemotherapy Platinum based Standard of Care Chemotherapy

Eligibility Criteria

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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

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 \[eg, colitis or Crohn's disease\]
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart McIntosh, MD

Role: STUDY_DIRECTOR

AstraZeneca, Alderley Park, Cheshire, UK

Naiyer Rizvi, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University Medical Center, New York, NY, USA

Locations

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Research Site

Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Yuma, Arizona, United States

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Bakersfield, California, United States

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Fullerton, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Redondo Beach, California, United States

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Sacramento, California, United States

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San Luis Obispo, California, United States

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Santa Maria, California, United States

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West Hollywood, California, United States

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New Haven, Connecticut, United States

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Jacksonville, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Athens, Georgia, United States

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Honolulu, Hawaii, United States

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Baltimore, Maryland, United States

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Minneapolis, Minnesota, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Summit, New Jersey, United States

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Mineola, New York, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Charlotte, North Carolina, United States

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Cleveland, Ohio, United States

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North Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Richmond, Virginia, United States

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Madison, Wisconsin, United States

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Box Hill, , Australia

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Gosford, , Australia

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Kogarah, , Australia

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Melbourne, , Australia

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Port Macquarie, , Australia

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Southport, , Australia

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St Leonards, , Australia

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Brussels, , Belgium

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Charleroi, , Belgium

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Duffel, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Greater Sudbury, Ontario, Canada

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Kingston, Ontario, Canada

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Newmarket, Ontario, Canada

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Oshawa, Ontario, Canada

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Sault Ste. Marie, Ontario, Canada

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St. Catharines, Ontario, Canada

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Toronto, Ontario, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

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Bordeaux, , France

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Brest, , France

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Créteil, , France

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Lille, , France

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Lyon, , France

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Marseille, , France

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Aachen, , Germany

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Bad Berka, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Freiburg im Breisgau, , Germany

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Gauting, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Hemer, , Germany

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Homburg/Saar, , Germany

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Immenhausen, , Germany

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Löwenstein, , Germany

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Lübeck, , Germany

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Mainz, , Germany

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Münster, , Germany

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Oldenburg, , Germany

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Ulm, , Germany

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Velbert, , Germany

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Würzburg, , Germany

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Budapest, , Hungary

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Deszk, , Hungary

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Edelény, , Hungary

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Kaposvár, , Hungary

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Kecskemét, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Székesfehérvár, , Hungary

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Genova, , Italy

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Meldola, , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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San Giovanni Rotondo, , Italy

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Siena, , Italy

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Fukushima, , Japan

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Himeji-shi, , Japan

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Hirakata-shi, , Japan

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Hirosaki-shi, , Japan

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Iizuka-shi, , Japan

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Iwakuni-shi, , Japan

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Izumi-shi, , Japan

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Kanazawa, , Japan

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Kishiwada-shi, , Japan

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Kobe, , Japan

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Koga-shi, , Japan

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Kyoto, , Japan

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Kyoto, , Japan

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Mitaka-shi, , Japan

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Nagaoka-shi, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Osaka, , Japan

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Saga, , Japan

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Saitama-shi, , Japan

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Sakaishi, , Japan

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Sayama, , Japan

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Sendai, , Japan

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Shinjuku-ku, , Japan

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Tokushima, , Japan

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Ube-shi, , Japan

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Yokohama, , Japan

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Yokohama, , Japan

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Yokosuka-shi, , Japan

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's-Hertogenbosch, , Netherlands

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Breda, , Netherlands

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Groningen, , Netherlands

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Maastricht, , Netherlands

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Rotterdam, , Netherlands

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Obninsk, , Russia

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Omsk, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Busan, , South Korea

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Changwon-si, , South Korea

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Cheongju-si, , South Korea

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Daegu, , South Korea

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Daegu, , South Korea

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Daejeon, , South Korea

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Goyang-si, , South Korea

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Incheon, , South Korea

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Jinju, , South Korea

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Seongnam-si, , South Korea

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Seongnam-si, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Suwon, , South Korea

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Ulsan, , South Korea

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A Coruña, , Spain

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Girona, , Spain

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Jaén, , Spain

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León, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Majadahonda, , Spain

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Málaga, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Bellinzona, , Switzerland

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Lausanne, , Switzerland

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Kaohsiung City, , Taiwan

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Kaohsiung City, , Taiwan

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Taichung, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Bangkok, , Thailand

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Chiang Mai, , Thailand

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Hat Yai, , Thailand

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Khon Kaen, , Thailand

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Hanoi, , Vietnam

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Hanoi, , Vietnam

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Ho Chi Minh City, , Vietnam

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Ho Chi Minh City, , Vietnam

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Countries

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United States Australia Belgium Canada France Germany Hungary Italy Japan Netherlands Russia South Korea Spain Switzerland Taiwan Thailand Vietnam

References

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Garon EB, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, Robinet G, Le Moulec S, Natale R, Schneider J, Shepherd FA, Garassino MC, Geater SL, Szekely ZP, Van Ngoc T, Liu F, Scheuring U, Patel N, Peters S, Rizvi NA. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC). Clin Lung Cancer. 2021 Jul;22(4):301-312.e8. doi: 10.1016/j.cllc.2021.02.010. Epub 2021 Feb 19.

Reference Type DERIVED
PMID: 33775558 (View on PubMed)

Rizvi NA, Cho BC, Reinmuth N, Lee KH, Luft A, Ahn MJ, van den Heuvel MM, Cobo M, Vicente D, Smolin A, Moiseyenko V, Antonia SJ, Le Moulec S, Robinet G, Natale R, Schneider J, Shepherd FA, Geater SL, Garon EB, Kim ES, Goldberg SB, Nakagawa K, Raja R, Higgs BW, Boothman AM, Zhao L, Scheuring U, Stockman PK, Chand VK, Peters S; MYSTIC Investigators. Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):661-674. doi: 10.1001/jamaoncol.2020.0237.

Reference Type DERIVED
PMID: 32271377 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

Access external resources that provide additional context or updates about the study.

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419AC00001&attachmentIdentifier=44a72f97-af1b-4e4c-8b0e-d65a6cc9cc88&fileName=D419AC00001_Statistical_Analysis_Plan_Redacted.pdf&versionIdentifier=

Related Info

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D419AC00001&attachmentIdentifier=cbfa257d-1cad-4287-aa97-aaad910d92df&fileName=D419AC00001_Version_8.0_CSP_Redacted.pdf&versionIdentifier=

Related Info

Other Identifiers

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2015-001279-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D419AC00001

Identifier Type: -

Identifier Source: org_study_id

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