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Chemotherapy

Durvalumab + Chemotherapy for Lung Cancer (AEGEAN Trial)

Phase 3
Waitlist Available
Led By John Heymach, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization to 2 months after resection
Awards & highlights

AEGEAN Trial Summary

This trial is testing a new cancer treatment combining a drug called durvalumab with chemotherapy. The study will compare how well the new treatment works compared to chemotherapy alone.

Who is the study for?
Adults over 18 with newly diagnosed, untreated non-small cell lung cancer that can be surgically removed may join. They should have good physical function and no prior immune therapy or certain other cancers. Surgery must be planned (lobectomy, sleeve resection, bilobectomy) and they cannot have brain metastases, active infections like TB or HIV, a history of organ transplant, or autoimmune diseases.Check my eligibility
What is being tested?
The trial is testing Durvalumab combined with chemotherapy before surgery against a placebo plus chemotherapy to see if it leads to complete removal of the tumor. It's randomized and double-blind meaning neither doctors nor patients know who gets the real drug versus placebo.See study design
What are the potential side effects?
Durvalumab might cause immune-related side effects such as inflammation in various organs, infusion reactions similar to allergic responses when receiving the drug intravenously, fatigue, potential for infection increase due to weakened immunity.

AEGEAN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have at least one cancer spot that can be measured and hasn't been treated with radiation.
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I have not had treatments like immunotherapy for my condition.
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I have a new, untreated lung cancer that can be surgically removed.
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I have provided a biopsy sample for EGFR and ALK testing.
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My organs and bone marrow are working well.
Select...
My upcoming surgery is a lobectomy, sleeve resection, or bilobectomy.
Select...
I am 18 years old or older.

AEGEAN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization to 2 months after resection
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization to 2 months after resection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-Free Survival (EFS) in modified intent to treat (mITT) population
Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population
Secondary outcome measures
Disease-Free Survival (DFS) in PD-L1-TC ≥1% patients in modified resected population
Disease-free survival (DFS) in modified resected population
Event-free survival (EFS) in PD-L1-TC ≥1% patients in modified intent to treat (mITT) population
+9 more
Other outcome measures
Number of participants with adverse events as assessed by CTCAE v5.0

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT03015129
65%
Fatigue
63%
Abdominal pain
55%
Diarrhea
43%
Pain
40%
Weight loss
35%
Hypertension
30%
Anorexia
30%
Constipation
28%
Nausea
28%
Pruritus
25%
Vomiting
20%
Urinary tract infection
20%
Dyspnea
18%
Rash maculo-papular
15%
Abdominal Pain
15%
Back pain
15%
Weight gain
15%
Cough
15%
Increased Urinary Frequency
13%
Arthralgia
10%
Dizziness
10%
Anxiety
10%
Bladder infection
10%
Nasal congestion
10%
Vaginal discharge
8%
Anal pain
8%
Dry skin
8%
Urinary frequency
8%
Edema limbs
8%
Flatulence
8%
Myalgia
8%
Hot flashes
8%
Thromboembolic event
8%
Fever
8%
Colitis
8%
Dry mouth
8%
Headache
8%
Small intestinal obstruction
8%
Urinary tract pain
5%
Ascites
5%
Lymphedema
5%
Memory impairment
5%
Mucositis oral
5%
Pneumonitis
5%
Confusion
5%
Gastroesophageal reflux disease
5%
Anemia
5%
Urinary urgency
5%
Vaginal hemorrhage
5%
Sinus bradycardia
5%
Hypomagnesemia
5%
Rash acneiform
5%
Renal and urinary disorders - Other, specify
5%
Adrenal insufficiency
5%
Upper respiratory infection
3%
Rectal hemorrhage
3%
CPK increased
3%
Fall
3%
Skin infection
3%
Muscle weakness left-sided
3%
Myositis
3%
Hyperglycemia
3%
Peripheral sensory neuropathy
3%
Colonic perforation
3%
Pain in extremity
3%
Blood bilirubin increased
3%
Rectal pain
3%
Weight Loss
3%
Alanine aminotransferase increased
3%
Aspartate aminotransferase increased
3%
Alkaline phosphatase increased
3%
Creatinine increased
3%
Lethargy
3%
Left ventricular systolic dysfunction
3%
Dysarthria
3%
Hypothyroidism
3%
Myocarditis
3%
Pleural effusion
3%
Hyperkalemia
3%
Generalized muscle weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalubmab
Durvalubmab + Tremelimumab

AEGEAN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: Durvalumab with platinum-based chemotherapyExperimental Treatment7 Interventions
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)
Group II: Arm 2: Placebo with platinum-based chemotherapyPlacebo Group7 Interventions
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)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin
2014
Completed Phase 3
~6670
Pemetrexed
2014
Completed Phase 3
~5250
Gemcitabine
2017
Completed Phase 3
~2070
Cisplatin
2013
Completed Phase 3
~1940
Surgery
2000
Completed Phase 3
~2550
Durvalumab
2017
Completed Phase 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,240 Previous Clinical Trials
288,520,794 Total Patients Enrolled
John Heymach, MDPrincipal InvestigatorUT MD Anderson Cancer Center
1 Previous Clinical Trials
62 Total Patients Enrolled

Media Library

Carboplatin (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03800134 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm 2: Placebo with platinum-based chemotherapy, Arm 1: Durvalumab with platinum-based chemotherapy
Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03800134 — Phase 3
Carboplatin (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03800134 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study limited to senior citizens, or will other age groups be considered?

"The aim of this study is to enroll patients who are between the ages of 18 and 120."

Answered by AI

How can I sign up to participate in this research project?

"Eligible patients for this study must have non-small cell lung carcinoma (nsclc), be between 18 and 120 years old, and there are looking to enroll 816 total patients."

Answered by AI

Are there any slots left for participants in this experiment?

"The clinical trial in question is not, at present, actively recruiting patients. According to the information available on clinicaltrials.gov, the study was first posted on December 6th 2018 and last updated on August 16th 2022. There are, however, 4111 other studies that are presently looking for candidates."

Answered by AI

Are there any severe side effects associated with Durvalumab?

"There is both pre-existing data and clinical evidence supporting the safety of Durvalumab, thus it received a score of 3."

Answered by AI

What is the primary illness that Durvalumab has been known to target?

"Durvalumab has multiple approved indications, including the treatment of metastatic ureter urothelial carcinoma, lymphoma, and locally advanced non-small cell lung cancer."

Answered by AI

How many people are going to be participating in this clinical trial?

"This study is no longer taking in new participants. It was first posted on December 6th, 2018 and most recently updated on August 16th, 2022. For those still interested in participating in non-small cell lung carcinoma (nsclc) research, there are presently 2095 trials actively admitting patients. Additionally, 2016 studies for Durvalumab are also seeking participants."

Answered by AI
~132 spots leftby Mar 2025