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Clinical Trials in Italy / NCT03800134
Active, not recruiting Phase 3

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

NCT03800134 · tracked via the Priya Life Science Italy tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2018-12-06
Last updated
2025-06-11

Condition(s) studied

Non-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Durvalumab →PlaceboCarboplatin →Cisplatin →Pemetrexed →Paclitaxel →Gemcitabine →Surgery

Durvalumab: 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

Placebo: 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

Carboplatin: Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles

Cisplatin: 75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles

Pemetrexed: 500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

Paclitaxel: 200mg/m2 on Day 1 of each 3-week cycle for 4 cycles.

Gemcitabine: 1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles.

Surgery: Expected within 40 days from the last dose of Investigational Product following the completion of neoadjuvant treatment.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
120 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population — Up to approximately 15 weeks after randomization
    Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
  • Event-Free Survival (EFS) in modified intent to treat (mITT) population — Up to 5.5 years after first patient randomized.
    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.

Trial sites (231)

FacilityCityRegionStatus
Research Site Phoenix Arizona
Research Site Duarte California
Research Site Orange California
Research Site Aurora Colorado
Research Site Boca Raton Florida
Research Site Jacksonville Florida
Research Site Chicago Illinois
Research Site Wichita Kansas
Research Site Ashland Kentucky
Research Site Lexington Kentucky
Research Site Silver Spring Maryland
Research Site Towson Maryland
Research Site Duluth Minnesota
Research Site Minneapolis Minnesota
Research Site Morristown New Jersey
Research Site New York New York
Research Site New York New York
Research Site Shirley New York
Research Site Durham North Carolina
Research Site Bend Oregon
Research Site Medford Oregon
Research Site Pittsburgh Pennsylvania
Research Site Charleston South Carolina
Research Site Charleston South Carolina
Research Site Austin Texas
Research Site Fort Worth Texas
Research Site Houston Texas
Research Site Houston Texas
Research Site Fairfax Virginia
Research Site Kirkland Washington
Research Site Seattle Washington
Research Site Buenos Aires Argentina
Research Site CABA Argentina
Research Site CABA Argentina
Research Site La Plata Argentina
Research Site Pergamino Argentina
Research Site Rosario Argentina
Research Site San Salvador de Jujuy Argentina
Research Site Viedma Argentina
Research Site Graz Austria

+ 191 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile →

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Observational Study on the Clinical Profile of Patients With Uncontrolled Severe Asthma Treated With Tezepelumab in Italy Active, not recruiting

Other trials for the same condition

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An Observational Study to Assess the Effectiveness and Safety of a Cemiplimab in Adult Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) in Routine Clinical Practice Settings in Europe Recruiting
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02) Starting soon
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014) Recruiting
A Clinical Trial of Calderasib (MK-1084) and Durvalumab in People With Non-Small Cell Lung Cancer (MK-1084-015/KANDLELIT-015) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03800134 on ClinicalTrials.gov ↗ ← All trials in Italy