NCT03800134|Active Not RecruitingPhase 3DMCFDA Drug

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

AEGEAN

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)

AstraZeneca ClinicalTrials.gov

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2 other identifiers

D9106C000012018-002997-29

Study Type

interventional

Target

825

Locations

28 countries

Sites

231

Timeline

RegisteredJan 2019

StartedDec 2018

CompletionSep 2028

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

825

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline

28mo left

Started Dec 2018

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

28 countries

231 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9.8 years study duration

Study Progress76%

Dec 2018Sep 2028

Study Start

First participant enrolled

December 6, 2018

Completed

1 day until next milestone

First Submitted

Initial submission to the registry

December 7, 2018

Completed

1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed

5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2028

Expected

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3.9 years

First QC Date

December 7, 2018

Last Update Submit

June 10, 2025

Conditions

Non-Small Cell Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

Secondary Outcomes (12)

Disease-free survival (DFS) in modified resected population
From date of randomization to approximately 5.5 years after date of resection
Major Pathological Response (mPR) in modified intent to treat (mITT) population
Up to approximately 15 weeks after randomization
Overall Survival (OS) in modified intent to treat (mITT) population
From date of randomization to 5.5 years after randomization
Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
From date of randomization to 5.5 years after randomization
pCR in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
Up to approximately 15 weeks after randomization
+7 more secondary outcomes

Other Outcomes (1)

Number of participants with adverse events as assessed by CTCAE v5.0
From date of randomization to 3 months after last dose of IP

Study Arms (2)

Arm 1: Durvalumab with platinum-based chemotherapy

EXPERIMENTAL

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)

Drug: DurvalumabDrug: CarboplatinDrug: CisplatinDrug: PemetrexedDrug: PaclitaxelDrug: GemcitabineProcedure: Surgery

Arm 2: Placebo with platinum-based chemotherapy

PLACEBO COMPARATOR

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)

Other: PlaceboDrug: CarboplatinDrug: CisplatinDrug: PemetrexedDrug: PaclitaxelDrug: GemcitabineProcedure: Surgery

Interventions

DurvalumabDRUG

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

Also known as: MEDI4736

Arm 1: Durvalumab with platinum-based chemotherapy

PlaceboOTHER

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

Arm 2: Placebo with platinum-based chemotherapy

CarboplatinDRUG

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