A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer (NCT03800134) — Austria Trial Details

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)

Facility	City	Region
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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