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A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

NCT03800134

Description:

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
  • Official Title: A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)

Clinical Trial IDs

  • ORG STUDY ID: D9106C00001
  • NCT ID: NCT03800134

Conditions

  • Non-Small Cell Lung Cancer

Interventions

DrugSynonymsArms
DurvalumabMEDI4736Arm 1: Durvalumab + platinum-based chemotherapy
Carboplatin/PaclitaxelArm 1: Durvalumab + platinum-based chemotherapy
Cisplatin/GemcitabineArm 1: Durvalumab + platinum-based chemotherapy
Pemetrexed/CisplatinArm 1: Durvalumab + platinum-based chemotherapy
Pemetrexed/CarboplatinArm 1: Durvalumab + platinum-based chemotherapy

Purpose

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathological response.

Trial Arms

NameTypeDescriptionInterventions
Arm 1: Durvalumab + platinum-based chemotherapyExperimentalDurvalumab ((MEDI4736) in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel cisplatin/gemcitabine pemetrexed/cisplatin pemetrexed/carboplatin
  • Durvalumab
  • Carboplatin/Paclitaxel
  • Cisplatin/Gemcitabine
  • Pemetrexed/Cisplatin
  • Pemetrexed/Carboplatin
Arm 2: Placebo + platinum-based chemotherapyPlacebo ComparatorPlacebo in concurrence with platinum-based chemo-radiation therapy. All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion: carboplatin/paclitaxel cisplatin/gemcitabine pemetrexed/cisplatin pemetrexed/carboplatin
  • Carboplatin/Paclitaxel
  • Cisplatin/Gemcitabine
  • Pemetrexed/Cisplatin
  • Pemetrexed/Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years

          -  Histologically or cytologically documented NSCLC with resectable (Stage IIA to select
             [ie, N2] Stage IIIB) disease

          -  World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment

          -  At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target
             Lesion (TL) at baseline

          -  No prior exposure to immune-mediated therapy including, but not limited to, other
             anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic
             anticancer vaccines

          -  Adequate organ and marrow function

          -  Confirmation of a patients tumour PD-L1 status

          -  Documented EGFR and ALK status

        Exclusion Criteria:

          -  History of allogeneic organ transplantation

          -  Active or prior documented autoimmune or inflammatory disorders (including
             inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis
             syndrome, or Wegener syndrome)

          -  History of another primary malignancy

          -  History of active primary immunodeficiency

          -  Active infection including tuberculosis hepatitis B, or human immunodeficiency virus

          -  Deemed unresectable NSCLC by multidisciplinary evaluation

          -  Patients who have pre-operative radiotherapy treatment as part of their care plan

          -  Patients who have brain metastases or spinal cord compression

          -  Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC

          -  Mixed small cell and NSCLC histology

          -  Patients who are candidates to undergo only segmentectomies or wedge resections
      
Maximum Eligible Age:120 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Major Pathological Response (mPR)
Time Frame:From screening pathology to an average of 15 weeks after first dose.
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Pathological complete response (pCR)
Time Frame:From screening pathology to an average of 15 weeks after first dose.
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:From date of randomization to 5.5 years after randomization
Safety Issue:
Description:
Measure:Event-free survival (EFS)
Time Frame:From date of randomization to 5.5 years after randomization
Safety Issue:
Description:
Measure:Disease-free survival (DFS)
Time Frame:From date of randomization to 5.5 years after date or resection
Safety Issue:
Description:
Measure:To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
Time Frame:From date of screening to 6 months after last dose of IP
Safety Issue:
Description:
Measure:To assess the PK of durvalumab in blood (through concentration)
Time Frame:From date of randomization to 2 months after resection
Safety Issue:
Description:
Measure:Presence of ADA for durvalumab
Time Frame:From date of randomization to 3 months after last dose of IP
Safety Issue:
Description:
Measure:mPR in PD-L1-TC positive patients
Time Frame:From screening pathology to an average of 15 weeks after first dose
Safety Issue:
Description:
Measure:To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
Time Frame:From date of screening to 6 months after last dose of IP
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:AstraZeneca

Trial Keywords

  • Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer

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