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NCT03800134 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
ACTIVE NOT RECRUITING
Registry last update
2025-06-11

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 pathological complete response.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Newly diagnosed and previously untreated patients with 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 patient's tumour PD-L1 status * Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status * Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy 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 and C, 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 * Known allergy or hypersensitivity to any of the study drugs or excipients * Existence of more than one primary tumour such as mixed small cell and NSCLC histology * Patients whose planned surgery at enrollment includes any of the following procedures: pneumonectomy, segmentectomies, or wedge resections * Patients with a documented test result confirming the presence of EGFRm or ALK translocation
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients will receive durvalumab 1500 mg in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by durvalumab 1500 mg monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
    intervention Names
    1. Drug: Durvalumab
    2. Drug: Carboplatin
    3. Drug: Cisplatin
    4. Drug: Pemetrexed
    5. Drug: Paclitaxel
    6. Drug: Gemcitabine
    7. Procedure: Surgery
    label
    Arm 1: Durvalumab with platinum-based chemotherapy
    type
    EXPERIMENTAL
  2. description
    Patients will receive placebo in combination with platinum-based chemotherapy every 3 weeks for up to 4 cycles prior to surgery, followed by placebo monotherapy every 4 weeks for up to 12 cycles after surgery unless disease is deemed unresectable, disease recurrence, or unacceptable toxicity The platinum-based chemotherapy will be based on tumour histology and Investigator discretion: * cisplatin with pemetrexed * carboplatin with pemetrexed * carboplatin with paclitaxel * cisplatin with gemcitabine (or carboplatin with gemcitabine for patients who have comorbidities or who are unable to tolerate cisplatin per the investigator's judgment)
    intervention Names
    1. Other: Placebo
    2. Drug: Carboplatin
    3. Drug: Cisplatin
    4. Drug: Pemetrexed
    5. Drug: Paclitaxel
    6. Drug: Gemcitabine
    7. Procedure: Surgery
    label
    Arm 2: Placebo with platinum-based chemotherapy
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Arm 1: Durvalumab with platinum-based chemotherapy
    description
    1500mg on Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and 1500mg on Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
    name
    Durvalumab
    other Names
    1. MEDI4736
    type
    DRUG
  2. arm Group Labels
    1. Arm 2: Placebo with platinum-based chemotherapy
    description
    Day 1 of each 3-week cycle for 4 cycles during the neoadjuvant period and Day 1 of each 4-week cycle for 12 cycles during the adjuvant period
    name
    Placebo
    type
    OTHER
  3. arm Group Labels
    1. Arm 1: Durvalumab with platinum-based chemotherapy
    2. Arm 2: Placebo with platinum-based chemotherapy
    description
    Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles
    name
    Carboplatin
    type
    DRUG
  4. arm Group Labels
    1. Arm 1: Durvalumab with platinum-based chemotherapy
    2. Arm 2: Placebo with platinum-based chemotherapy
    description
    75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles
    name
    Cisplatin
    type
    DRUG
  5. arm Group Labels
    1. Arm 1: Durvalumab with platinum-based chemotherapy
    2. Arm 2: Placebo with platinum-based chemotherapy
    description
    500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
    name
    Pemetrexed
    type
    DRUG
  6. arm Group Labels
    1. Arm 1: Durvalumab with platinum-based chemotherapy
    2. Arm 2: Placebo with platinum-based chemotherapy
    description
    200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.
    name
    Paclitaxel
    type
    DRUG
  7. arm Group Labels
    1. Arm 1: Durvalumab with platinum-based chemotherapy
    2. Arm 2: Placebo with platinum-based chemotherapy
    description
    1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.
    name
    Gemcitabine
    type
    DRUG
  8. arm Group Labels
    1. Arm 1: Durvalumab with platinum-based chemotherapy
    2. Arm 2: Placebo with platinum-based chemotherapy
    description
    Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.
    name
    Surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
primary Purpose
TREATMENT
Enrollment
count
825
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. measure
    Number of participants with adverse events as assessed by CTCAE v5.0
    time Frame
    From date of randomization to 3 months after last dose of IP
primary Outcomes
  1. description
    Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
    measure
    Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population
    time Frame
    Up to approximately 15 weeks after randomization
  2. description
    An event is defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
    measure
    Event-Free Survival (EFS) in modified intent to treat (mITT) population
    time Frame
    Up to 5.5 years after first patient randomized.
secondary Outcomes
  1. measure
    Disease-free survival (DFS) in modified resected population
    time Frame
    From date of randomization to approximately 5.5 years after date of resection
  2. measure
    Major Pathological Response (mPR) in modified intent to treat (mITT) population
    time Frame
    Up to approximately 15 weeks after randomization
  3. measure
    Overall Survival (OS) in modified intent to treat (mITT) population
    time Frame
    From date of randomization to 5.5 years after randomization
  4. measure
    Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
    time Frame
    From date of randomization to 5.5 years after randomization
  5. measure
    pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
    time Frame
    Up to approximately 15 weeks after randomization
  6. measure
    Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population
    time Frame
    From date of randomization to 5.5 years after date of resection
  7. measure
    Major Pathological Response (mPR) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
    time Frame
    Up to approximately 15 weeks after randomization
  8. measure
    Overall Survival (OS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
    time Frame
    From date of randomization to 5.5 years after randomization.
  9. description
    To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
    measure
    To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
    time Frame
    From date of screening to 6 months after last dose of IP
  10. description
    To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
    measure
    To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery
    time Frame
    From date of screening to 6 months after last dose of IP
  11. description
    To assess concentration of durvalumab in bloodstream.
    measure
    To assess the PK of durvalumab in blood
    time Frame
    From date of randomization to 2 months after resection
  12. description
    To evaluate the presence of antibodies following treatment with study medications.
    measure
    Presence of ADA for durvalumab
    time Frame
    From date of randomization to 3 months after last dose of IP
Full 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 pathological complete response.
Source references
references
  1. citation
    Mitsudomi T, Heymach JV, Reck M, Taube JM, Gao S, Horio Y, You J, Li G, Van Luong D, Saeteng S, Tanaka F, Watzka SB, Urban L, Szalai Z, Akamatsu H, Kang JH, Orlandi FJ, Mukhametshina GZ, Pircher A, Teixeira CHA, Aperghis M, Doherty GJ, Doake R, Fouad TM, Harpole D. Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC. J Thorac Oncol. 2025 Nov;20(11):1639-1654. doi: 10.1016/j.jtho.2025.06.015. Epub 2025 Jun 20.
    pmid
    40545237
    type
    DERIVED
  2. citation
    Heymach JV, Harpole D, Mitsudomi T, Taube JM, Galffy G, Hochmair M, Winder T, Zukov R, Garbaos G, Gao S, Kuroda H, Ostoros G, Tran TV, You J, Lee KY, Antonuzzo L, Papai-Szekely Z, Akamatsu H, Biswas B, Spira A, Crawford J, Le HT, Aperghis M, Doherty GJ, Mann H, Fouad TM, Reck M; AEGEAN Investigators. Perioperative Durvalumab for Resectable Non-Small-Cell Lung Cancer. N Engl J Med. 2023 Nov 2;389(18):1672-1684. doi: 10.1056/NEJMoa2304875. Epub 2023 Oct 23.
    pmid
    37870974
    type
    DERIVED
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