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Dosing and Administration:  AEGEAN Regimen

IMFINZI in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by IMFINZI as monotherapy after surgery, is indicated for the treatment of adults with resectable (tumours ≥4 cm and/or node positive) NSCLC and no known EGFR mutations or ALK rearrangements.²

For full information on dosing and administration, refer to the IMFINZI Summary of Product Characteristics.

AEGEAN Regimen provides a flexible treatment option, allowing you to continue with IMFINZI monotherapy after surgery³

IMFINZI dosage for Stage IIA-IIIB (N2) resectable NSCLC

The AEGEAN Regimen offers flexibility in the choice of carboplatin- or cisplatin-based CT^2,3

See the EFS data in the AEGEAN Regimen for carboplatin and cisplatin here
The recommended IMFINZI (durvalumab) dosage for resectable NSCLC is:

Neoadjuvant: Q3W x up to 4 cycles²

Image of the AEGEAN Regimen perioperative Imfinzi (durvalumab) with chemotherapy dosing around surgery in resectable NSCLC

Adjuvant: Q4W up to 12 cycles²

Adapted from IMFINZI Summary of Product Characteristics.²

Treat until disease is deemed unresectable, recurrence, unacceptable toxicity, or a maximum of 12 cycles after surgery²

For patients with a body weight ≤30 kg: IMFINZI 20 mg/kg Q3W (21 days) in combination with CT prior to surgery, and then IMFINZI monotherapy 20 mg/kg Q4W after surgery until weight is >30 kg²

Routine monitoring of patients for signs and symptoms of infusion-related reactions and adverse reactions is essential²

Systemic corticosteroids, endocrine therapy or other immunosuppressants can be used after starting IMFINZI to treat imAEs where clinically appropriate*²

For a full list of treatment modifications, refer to the section 4.2 of the IMFINZI Summary of Product Characteristics.²

*The use of systemic corticosteroids or immunosuppressants before starting IMFINZI, except physiological dose of systemic corticosteroids (≤10 mg/day prednisone or equivalent), is not recommended because of their potential interference with the pharmacodynamic activity and efficacy of IMFINZI.²

Dose modifications

No dose escalation or reduction of Imfinzi is recommended, except for instances where a weight-based adjustment in dose is required.

Dose withholding or discontinuation may be required based on individual safety and tolerability.

For information about dose modifications in relation to immune-mediated and non-immune-mediated adverse reactions please review the Summary of Product Characteristics.

IMFINZI administration

For detailed instructions on preparation of solution please see below or refer to section 6.6 of the IMFINZI Summary of Product Characteristics.²

Administer the infusion solution intravenously over 1 hour through an intravenous line containing a sterile, low-protein binding 0.2 to 0.22 μm in-line filter.²

Do not co-administer other medicinal products through the same infusion line.²

For treatment modifications for IMFINZI please refer to section 4.2 in the SmPC.²

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.²

When IMFINZI is administered in combination with chemotherapy, administer IMFINZI prior to chemotherapy on the same day.¹

Paediatric population

The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age has not been established regarding NSCLC. No data are available. For more information, please see section 5.1 and 5.2 of the IMFINZI Summary of Product Characteristics.²

Elderly

No dose adjustment is required for elderly patients (≥65 years of age). For more information, please see section 5.1 of the IMFINZI Summary of Product Characteristics.²

Renal impairment

No dose adjustment of IMFINZI is recommended in patients with mild or moderate renal impairment. Data from patients with severe renal impairment are too limited to draw conclusions on this population. For more information, please see section 5.2 of the IMFINZI Summary of Product Characteristics.²

Hepatic impairment

Data from patients with severe hepatic impairment are limited. Due to minor involvement of hepatic processes in the clearance of durvalumab no dose adjustment of IMFINZI is recommended for patients with hepatic impairment as no difference in exposure is expected. For more information, please see section 5.2 of the IMFINZI Summary of Product Characteristics.²

For the full list of special warnings and precautions, please see section 4.4 of the IMFINZI Summary of Product Characteristics.

Patients with pre-existing AID

In patients with pre-existing AID, data from observational studies suggest an increased risk of immune-related adverse reactions following immune-checkpoint inhibitor therapy as compared with patients without pre-existing AID. In addition, flares of the underlying AID were frequent, but the majority were mild and manageable.²

Patients excluded from clinical trials

Patients with the following were excluded from clinical trials: a baseline ECOG performance score ≥2; active or prior documented autoimmune disease within 2 years of initiation of the study; a history of immunodeficiency; a history of severe immune-mediated adverse reactions; medical conditions that required systemic immunosuppression, except physiological dose of systemic corticosteroids (≤10 mg/day prednisone or equivalent), uncontrolled intercurrent illnesses; active tuberculosis or hepatitis B or C or HIV infection or patients receiving live attenuated vaccine within 30 days before or after the start of IMFINZI. In the absence of data, IMFINZI should be used with caution in these populations after careful consideration of the potential benefit/risk on an individual basis.²

IMFINZI is supplied as single-use vials, available in two dosage strengths: either 120 mg/2.4 mL (50 mg/ml) or 500 mg/10 mL (50 mg/mL).²

Inside is a clear-to-opalescent, colourless-to-slightly yellow solution in a type glass 1 vial with an elastomeric stopper and a grey flip-off aluminium seal for 2.4 ml vials or a white flip-off aluminium seal for 10 ml vials.²

The drug product must be visually inspected, and the vial must be discarded if the solution is cloudy, discoloured, or visible particles are observed prior to administration.²

Unopened vial

Shelf life: 3 years.²
Store in refrigerator (2 ˚C – 8 ˚C).²
Do not freeze.²
Store in the original package in order to protect from light.²

Diluted solution

Chemical and physical in-use stability has been demonstrated for up to 30 days at 2 ˚C – 8 ˚C and for up to 24 hours at room temperature (up to 25 ˚C) from the time of preparation.²

The prepared solution for infusion should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ˚C – 8 ˚C or 12 hours at room temperature (up to 25 ˚C), unless dilution has taken place in controlled and validated aseptic conditions.²

Preparation

IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.²

Visually inspect the medicinal product for particulate matter and discolouration. IMFINZI is a clear to opalescent, colourless to slightly yellow solution. Discard the vial if the solution is cloudy, discoloured or visible particles are observed. Do not shake the vial²

Withdraw the required volume from the vial(s) of IMFINZI and transfer into an IV bag containing sodium chloride 9 mg/mL (0.9%) solution for injection, or glucose 50 mg/mL (5%) solution for injection. Mix diluted solution by gentle inversion. The final concentration of the diluted solution should be between 1 mg/mL and 15 mg/mL. Do not freeze or shake the solution²

Discard any unused portion left in the vial²

Continue exploring the AEGEAN Regimen

Take a closer look at how IMFINZI works within the AEGEAN Regimen

Explore MOA

Discover more about the AEGEAN study design and efficacy outcomes

Explore efficacy data

Get to know the AEGEAN safety profile 

Explore safety data

AE – adverse event; AID - autoimmune disease; ALK – anaplastic lymphoma kinase; ALT – alanine aminotransferase; AST – aspartate aminotransferase; BLV – baseline value; BTC – biliary tract cancer; CRT – chemoradiotherapy; CT – chemotherapy; ECOG – Eastern Cooperative Oncology Group; EFS – event-free survival; EGFR – epidermal growth factor receptor; HCC – hepatocellular carcinoma; HIV – human immunodeficiency virus; imAE – immune-mediated adverse event; IV – intravenous; NICE – National Institute for Health and Care Excellence; NSCLC – non-small cell lung cancer; PD-L1 – programmed death-ligand 1; PS – performance status; Q3W – every 3 weeks; Q4W – every 4 weeks; RT – radiotherapy; SCLC – small cell lung cancer; ULN – upper limit of normal.

NICE. Durvalumab with chemotherapy before surgery (neoadjuvant) then alone after surgery (adjuvant) for treating resectable non-small-cell lung cancer. https://www.nice.org.uk/guidance/gid-ta11197/documents/674 [Accessed April 2025].
IMFINZI Summary of Product Characteristics.
Heymach JV et al. N Engl J Med. 2023;389(18):1672-1684.
NHS England. National Cancer Drugs Fund List. https://www.england.nhs.uk/wp-content/uploads/2017/04/National-Cancer-Drugs-Fund-list-version-1.341.pdf [Accessed April 2025].

GB-65594 | July 2025

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AstraZeneca by visiting https://contactazmedical.astrazeneca.com/ or by calling ‌‌‌0‌‌‌8‌‌‌‌‌0‌‌‌‌0‌‌‌ ‌‌7‌‌‌‌‌‌8‌‌‌3‌‌‌ ‌‌0‌‌‌‌‌0‌‌‌‌3‌‌‌‌3‌‌‌.

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Dosing and Administration:  AEGEAN Regimen

AEGEAN Regimen provides a flexible treatment option, allowing you to continue with IMFINZI monotherapy after surgery³