A Study of Neoadjuvant/adjuvant Durvalumab for the Treatment of Patients with Resectable Non-small Cell Lung Cancer - AEGEAN

Study identifier:D9106C00001

ClinicalTrials.gov identifier:NCT03800134

EudraCT identifier:2018-002997-29

CTIS identifier:N/A

Recruitment Complete

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)

Medical condition

Non-small Cell Lung Cancer

Phase

Phase 3

Healthy volunteers

Study drug

Durvalumab, Carboplatin, Cisplatin, Pemetrexed, Paclitaxel, Gemcitabine

Sex

All

Actual Enrollment

826

Study type

Interventional

Age

18 Years - 120 Years

Date

Study Start Date: 06 Dec 2018

Primary Completion Date: 10 Nov 2022

Estimated Study Completion Date: 11 Sept 2028

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Arm 1: Durvalumab with platinum-based chemotherapy 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: 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 Other Name: MEDI4736 Drug: Carboplatin Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles Drug: Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles. Drug: Paclitaxel 200mg/m2 on Day 1 of each 3-week cycle for 4 cycles. Drug: Gemcitabine 1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles. Procedure/Surgery: Surgery Expected within 40 days from the last dose of IP following the completion of neoadjuvant treatment (4 cycles of platinum based chemotherapy concurrent with durvalumab or placebo)
Placebo Comparator: Arm 2: Placebo with platinum-based chemotherapy 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: 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 Drug: Carboplatin Area under the curve of 5/6 on Day 1 of each 3-week cycle for 4 cycles Drug: Cisplatin 75 mg/m2 on Day 1 of each 3-week cycle, for 4 cycles Drug: Pemetrexed 500 mg/m2 on Day 1 of each 3-week cycle for 4 cycles. Drug: Paclitaxel 200mg/m2 on Day 1 of each 3-week cycle for 4 cycles. Drug: Gemcitabine 1250 mg/m2 on Day 1 and Day 8 of each 3-week cycle, for 4 cycles. Procedure/Surgery: Surgery Expected within 40 days from the last dose of IP following the completion of neoadjuvant treatment (4 cycles of platinum based chemotherapy concurrent with durvalumab or placebo)

Arms

Assigned Interventions

Experimental: Arm 1: Durvalumab with platinum-based chemotherapy
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: 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

Other Name: MEDI4736

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

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

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

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

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

Procedure/Surgery: Surgery
Expected within 40 days from the last dose of IP following the completion of neoadjuvant treatment (4 cycles of platinum based chemotherapy concurrent with durvalumab or placebo)

Placebo Comparator: Arm 2: Placebo with platinum-based chemotherapy
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: 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

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

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

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

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

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

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Contact Backup

AstraZeneca Cancer Study Locator

1-877-400-4656