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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

Must not have

Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus

Patients with a documented test result confirming the presence of EGFRm or ALK translocation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization to 2 months after resection

Awards & highlights

Pivotal 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.

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.

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.

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 upcoming surgery is a lobectomy, sleeve resection, or bilobectomy.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active infections like TB, hepatitis B or C, or HIV.

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My cancer has a confirmed EGFR mutation or ALK translocation.

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I have cancer that has spread to my brain or spinal cord.

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I have had another type of cancer before.

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I am scheduled for radiotherapy before surgery as part of my treatment.

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My lung cancer is at an advanced stage (IIIB N3, IIIC, IVA, or IVB).

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I have received an organ transplant from another person.

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My lung cancer cannot be removed with surgery.

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I have more than one type of lung cancer.

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My upcoming surgery involves removing part or all of a lung.

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I have or had an autoimmune or inflammatory disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization to 2 months after resection

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-Free Survival (EFS) in modified intent to treat (mITT) population

Pathological Complete Response (pCR) in modified intent-to-treat (mITT) population

Secondary study objectives

Presence of ADA for durvalumab

To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery

To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durvalumab + chemotherapy prior to surgery followed by durvalumab post-surgery compared with placebo + chemotherapy prior to surgery followed by placebo post-surgery

+1 more

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%

Dyspnea

20%

Urinary tract infection

18%

Rash maculo-papular

15%

Cough

15%

Abdominal Pain

15%

Back pain

15%

Increased Urinary Frequency

15%

Weight gain

13%

Arthralgia

10%

Dizziness

10%

Anxiety

10%

Bladder infection

10%

Nasal congestion

10%

Vaginal discharge

Colitis

Dry mouth

Dry skin

Fever

Anal pain

Edema limbs

Flatulence

Headache

Hot flashes

Myalgia

Small intestinal obstruction

Thromboembolic event

Urinary frequency

Urinary tract pain

Confusion

Renal and urinary disorders - Other, specify

Adrenal insufficiency

Anemia

Ascites

Gastroesophageal reflux disease

Hypomagnesemia

Lymphedema

Memory impairment

Mucositis oral

Pneumonitis

Rash acneiform

Sinus bradycardia

Upper respiratory infection

Urinary urgency

Vaginal hemorrhage

Alanine aminotransferase increased

Aspartate aminotransferase increased

Alkaline phosphatase increased

Colonic perforation

Dysarthria

Blood bilirubin increased

CPK increased

Creatinine increased

Myositis

Rectal hemorrhage

Hypothyroidism

Left ventricular systolic dysfunction

Lethargy

Muscle weakness left-sided

Myocarditis

Rectal pain

Weight Loss

Fall

Generalized muscle weakness

Hyperglycemia

Hyperkalemia

Pain in extremity

Peripheral sensory neuropathy

Pleural effusion

Skin infection

100%

80%

60%

40%

20%

Study treatment Arm

Durvalubmab

Durvalubmab + Tremelimumab

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Carboplatin

2014

Completed Phase 3

~6120

Pemetrexed

2014

Completed Phase 3

~5550