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History of Changes for Study: NCT03800134
A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer
Latest version (submitted November 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 8, 2019 None (earliest Version on record)
2 February 5, 2019 Contacts/Locations and Study Status
3 February 25, 2019 Study Status and Contacts/Locations
4 March 25, 2019 Contacts/Locations and Study Status
5 April 24, 2019 Contacts/Locations and Study Status
6 May 21, 2019 Contacts/Locations and Study Status
7 June 24, 2019 Contacts/Locations and Study Status
8 July 22, 2019 Contacts/Locations and Study Status
9 August 20, 2019 Contacts/Locations and Study Status
10 September 17, 2019 Contacts/Locations and Study Status
11 October 28, 2019 Contacts/Locations and Study Status
12 December 3, 2019 Contacts/Locations and Study Status
13 January 7, 2020 Contacts/Locations and Study Status
14 March 9, 2020 Contacts/Locations, Outcome Measures, Study Status, Arms and Interventions and Study Design
15 April 7, 2020 Contacts/Locations and Study Status
16 May 5, 2020 Contacts/Locations and Study Status
17 June 23, 2020 Contacts/Locations, Study Status and IPDSharing
18 July 23, 2020 Contacts/Locations and Study Status
19 September 9, 2020 Contacts/Locations and Study Status
20 October 9, 2020 Contacts/Locations and Study Status
21 November 10, 2020 Contacts/Locations and Study Status
22 November 16, 2020 Contacts/Locations and Study Status
23 December 16, 2020 Contacts/Locations and Study Status
24 January 15, 2021 Contacts/Locations and Study Status
25 February 18, 2021 Contacts/Locations and Study Status
26 March 19, 2021 Contacts/Locations and Study Status
27 April 16, 2021 Contacts/Locations and Study Status
28 May 26, 2021 Outcome Measures, Contacts/Locations, Study Status, IPDSharing, Eligibility, Arms and Interventions, Study Description, Oversight and Study Identification
29 June 21, 2021 Contacts/Locations and Study Status
30 July 21, 2021 Contacts/Locations and Study Status
31 August 23, 2021 Contacts/Locations and Study Status
32 September 22, 2021 Contacts/Locations and Study Status
33 November 9, 2021 Contacts/Locations and Study Status
34 January 10, 2022 Study Status and Study Identification
35 February 8, 2022 Contacts/Locations, Study Status, Outcome Measures and Study Identification
36 March 10, 2022 Contacts/Locations and Study Status
37 May 6, 2022 Contacts/Locations, Study Status and Study Design
38 June 7, 2022 Contacts/Locations and Study Status
39 July 14, 2022 Contacts/Locations and Study Status
40 August 12, 2022 Study Status and Contacts/Locations
41 August 16, 2022 Recruitment Status, Contacts/Locations, Study Status and Study Design
42 November 18, 2022 Study Status, Contacts/Locations and Study Design
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Study NCT03800134
Submitted Date:  January 8, 2019 (v1)

Open or close this module Study Identification
Unique Protocol ID: D9106C00001
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Recruiting
Study Start: December 6, 2018
Primary Completion: July 27, 2020 [Anticipated]
Study Completion: September 8, 2025 [Anticipated]
First Submitted: December 7, 2018
First Submitted that
Met QC Criteria:
January 8, 2019
First Posted: January 11, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
January 8, 2019
Last Update Posted: January 11, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: 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.
Detailed Description:
Open or close this module Conditions
Conditions: Non-Small Cell Lung Cancer
Keywords: Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, Non-small Cell Lung Cancer
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Double (Participant, Care Provider)
Allocation: Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Arm 1: Durvalumab + platinum-based chemotherapy

Durvalumab ((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
Drug: Durvalumab
Durvalumab IV (intravenous infusion)
Other Names:
  • MEDI4736
Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as per standard of care
Drug: Cisplatin/Gemcitabine
Cisplatin/Gemcitabine, as per standard of care
Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin, as per standard of care
Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin, as per standard of care
Placebo Comparator: Arm 2: Placebo + platinum-based chemotherapy

Placebo 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
Placebo
Placebo IV (intravenous infusion)
Drug: Carboplatin/Paclitaxel
Carboplatin/Paclitaxel, as per standard of care
Drug: Cisplatin/Gemcitabine
Cisplatin/Gemcitabine, as per standard of care
Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin, as per standard of care
Drug: Pemetrexed/Carboplatin
Pemetrexed/Carboplatin, as per standard of care
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Major Pathological Response (mPR)
[ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]

Secondary Outcome Measures:
1. Pathological complete response (pCR)
[ Time Frame: From screening pathology to an average of 15 weeks after first dose. ]

2. Overall Survival (OS)
[ Time Frame: From date of randomization to 5.5 years after randomization ]

3. Event-free survival (EFS)
[ Time Frame: From date of randomization to 5.5 years after randomization ]

4. Disease-free survival (DFS)
[ Time Frame: From date of randomization to 5.5 years after date or resection ]

5. 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 ]

6. To assess the PK of durvalumab in blood (through concentration)
[ Time Frame: From date of randomization to 2 months after resection ]

7. Presence of ADA for durvalumab
[ Time Frame: From date of randomization to 3 months after last dose of IP ]

8. mPR in PD-L1-TC positive patients
[ Time Frame: From screening pathology to an average of 15 weeks after first dose ]

9. 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 ]

Other Outcome Measures:
1. Number of participants with all adverse events as assessed by CTCAE v4.0 in durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
[ Time Frame: 82 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 120 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: AstraZeneca Clinical Study Information Center
Telephone: 1-877-240-9479
Email: information.center@astrazeneca.com
Study Officials: Leonardo Trani, MD
Principal Investigator
AstraZeneca
Locations: United States, Arizona
Research Site
[Not yet recruiting]
Phoenix, Arizona, United States, 85054
United States, California
Research Site
[Not yet recruiting]
Duarte, California, United States, 91010
United States, Illinois
Research Site
[Not yet recruiting]
Chicago, Illinois, United States, 60612
United States, Maryland
Research Site
[Not yet recruiting]
Silver Spring, Maryland, United States, 20910
United States, Texas
Research Site
[Not yet recruiting]
Houston, Texas, United States, 77090
Austria
Research Site
[Not yet recruiting]
Wien, Austria, 1090
Hungary
Research Site
[Not yet recruiting]
Budapest, Hungary, 1121
Research Site
[Not yet recruiting]
Budapest, Hungary, 1125
Research Site
[Not yet recruiting]
Győr, Hungary, 9024
Research Site
[Not yet recruiting]
Mátraháza, Hungary, H-3233
Research Site
[Not yet recruiting]
Törökbálint, Hungary, 2045
Japan
Research Site
[Not yet recruiting]
Himeji-shi, Japan, 670-8520
Research Site
[Not yet recruiting]
Iwakuni-shi, Japan, 740-8510
Research Site
[Not yet recruiting]
Kitaadachi-gun, Japan, 362-0806
Research Site
[Not yet recruiting]
Kurashiki-shi, Japan, 701-0192
Research Site
[Not yet recruiting]
Nagoya-shi, Japan, 464-8681
Research Site
[Not yet recruiting]
Niigata-shi, Japan, 951-8566
Research Site
[Not yet recruiting]
Okayama-shi, Japan, 700-8558
Research Site
[Not yet recruiting]
Wakayama-shi, Japan, 641-8510
Korea, Republic of
Research Site
[Not yet recruiting]
Busan, Korea, Republic of, 48108
Research Site
[Not yet recruiting]
Cheongju-si, Korea, Republic of, 28644
Research Site
[Not yet recruiting]
Incheon, Korea, Republic of, 21565
Research Site
[Not yet recruiting]
Seongnam-si, Korea, Republic of, 13620
Research Site
[Not yet recruiting]
Seoul, Korea, Republic of, 05505
Research Site
[Not yet recruiting]
Seoul, Korea, Republic of, 06591
Philippines
Research Site
[Not yet recruiting]
Makati, Philippines, 1229
Research Site
[Not yet recruiting]
Manila, Philippines
Research Site
[Not yet recruiting]
Quezon City, Philippines
Russian Federation
Research Site
[Not yet recruiting]
Krasnoyarsk, Russian Federation, 660133
Research Site
[Not yet recruiting]
Novosibirsk, Russian Federation, 630108
Research Site
[Not yet recruiting]
Omsk, Russian Federation, 644013
Research Site
[Not yet recruiting]
Rostov-on-Don, Russian Federation, 344037
Research Site
[Not yet recruiting]
Saint-Petersburg, Russian Federation, 194291
Research Site
[Not yet recruiting]
Syktyvkar, Russian Federation, 167904
Research Site
[Not yet recruiting]
Tomsk, Russian Federation, 634009
Taiwan
Research Site
[Not yet recruiting]
Taichung, Taiwan, 402
Research Site
[Not yet recruiting]
Taichung, Taiwan, 40705
Research Site
[Not yet recruiting]
Tainan City, Taiwan, 701
Research Site
[Not yet recruiting]
Taipei, Taiwan, 10002
Research Site
[Recruiting]
Taipei, Taiwan, 235
Vietnam
Research Site
[Not yet recruiting]
Ha Noi, Vietnam, 100000
Research Site
[Not yet recruiting]
Ho Chi Minh, Vietnam, 700000
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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