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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)

NCT02453282 · MYSTIC Phase 3Active, not recruiting

Lead sponsor
AstraZeneca (Industry)
Enrollment
1,118 (actual)
Start date
21 Jul 2015
Primary completion
4 Oct 2018 (actual)
Study completion
31 Dec 2026
Last update posted
6 Aug 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
3

Interventions

  • MEDI4736 (Durvalumab) Biological
  • MEDI4736 (Durvalumab)+Tremelimumab Biological
  • Paclitaxel + Carboplatin Drug
  • Gemcitabine + Cisplatin Drug
  • Gemcitabine + Carboplatin Drug
  • Pemetrexed + Cisplatin Drug
  • Pemetrexed + Carboplatin Drug
  • Tremelimumab Biological

Conditions and primary outcome

  • Non-Small-Cell Lung Carcinoma NSCLC

Primary outcome

Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy (From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).); Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy (Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).)

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT02453282 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy

    Time frame
    From baseline (Day 1, Week 0) until death due to any cause, assessed up to the data cut-off date (a maximum of approximately 3 years).
    Measure
    Median
    Unit
    months

    • Durvalumab Monotherapy vs SoC ChemotherapySuperiority

      Durvalumab Monotherapy Vs SoC Chemotherapy

      Estimate
      0.76Hazard Ratio (HR)
      97.54% CI, two-sided
      0.564 to 1.019
      p-value
      0.036
      Method
      Log Rank

    • Durvalumab + Tremelimumab vs SoC ChemotherapySuperiority

      Durvalumab + Tremelimumab Vs SoC Chemotherapy

      Estimate
      0.85Hazard Ratio (HR)
      98.77% CI, two-sided
      0.611 to 1.173
      p-value
      0.202
      Method
      Log Rank

  2. Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy

    Time frame
    Tumour scans performed at baseline then every 6 weeks up to 48 weeks relative to the date of randomization, then every 8 weeks thereafter until confirmed disease progression. Assessed up to the data cut-off date (a maximum of approximately 3 years).
    Measure
    Median
    Unit
    months

    • Durvalumab + Tremelimumab vs SoC ChemotherapySuperiority

      Durvalumab + Tremelimumab Vs SoC Chemotherapy

      Estimate
      1.05Hazard Ratio (HR)
      99.5% CI, two-sided
      0.722 to 1.534
      p-value
      0.705
      Method
      Log Rank

Serious adverse events

Time frame: From first administration of study treatment up to 90 days after last dose of durvalumab and tremelimumab or 30 days after last dose of SoC or date of initiation of the first subsequent therapy, whichever occurs first, approximately 3 years. All-cause mortality, from screening up to data cut-off date (approximately 3 years 1 month).

Participants with serious adverse events per group for MYSTIC, as posted
GroupAffectedAt risk
Durvalumab Monotherapy131369
Durvalumab + Tremelimumab178371
SoC Chemotherapy112352

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. Patient-Reported Outcomes with Durvalumab With or Without Tremelimumab Versus Standard Chemotherapy as First-Line Treatment of Metastatic Non-Small-Cell Lung Cancer (MYSTIC).

    Clinical lung cancer · 2021 Jul

    PubMed 33775558 (opens in a new tab)DOI 10.1016/j.cllc.2021.02.010 (opens in a new tab)

  2. 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 oncology · 2020 May 1

    PubMed 32271377 (opens in a new tab)DOI 10.1001/jamaoncol.2020.0237 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.