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Dosing and administration: CASPIAN Regimen

IMFINZI in combination with etoposide and either carboplatin or cisplatin is indicated for the first-line treatment of adults with extensive-stage small cell lung cancer (ES-SCLC).³

For full information on dosing and administration, refer to the IMFINZI Summary of Product Characteristics.³

Patients may have more time with the IMFINZI CASPIAN regimen vs EP + carboplatin or cisplatin, to enjoy what matters most³

Following induction therapy, patients should commence maintenance dosing of IMFINZI at Q4W³

See the OS data in the CASPIAN Regimen + EP here

The recommended IMFINZI (durvalumab) dosage for ES-SCLC is:

Induction:^1-3 Q3W for 4 cycles

Until disease progression or unacceptable toxicity

Image of the CASPIAN Regimen- Q3W Imfinzi (durvalumab) + EP, followed by Q4W maintenance Imfinzi monotherapy for ES-SCLC

Maintenance:^1-3 Q4W

Until disease progression or unacceptable toxicity

Routine monitoring of patients for signs and symptoms of infusion-related reactions and adverse reactions is essential.³

Adapted from IMFINZI Summary of Product Characteristics.³

Corticosteroids and other medicines may also be required. Most immune-mediated adverse reactions, including severe reactions, resolved following initiation of appropriate medical therapy and/or treatment modifications³
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. However, systemic corticosteroids or other immunosuppressants can be used after starting IMFINZI to treat immune-mediated adverse reactions³

* Patients with a body weight of 30 kg or less must receive weight-based dosing of IMFINZI at 20 mg/kg, in combination with chemotherapy dose every 3 weeks, followed by 20 mg/kg every 4 weeks as monotherapy until weight increases to greater than 30 kg⁴

ES-SCLC – extensive-stage small-cell lung cancer; Q3W – once every 3 weeks; Q4W – once every 4 weeks.

Dosage modification

Some situations may require dose interruption or discontinuation in response to adverse events:³

No dose escalation or reduction of IMFINZI is recommended, except for instances where a weight-based adjustment in dose is required³
Dose withholding or discontinuation may be required based on individual safety profile and tolerability³

All adverse events reported in the table are listed as special warnings in the IMFINZI SmPC. Please refer to the IMFINZI SmPC for a full list of adverse events and their management.³

For information about dose modifications in relation to immune-mediated and non-immune-mediated adverse reactions please review the IMFINZI SmPC.³

Adverse reaction	Severity*	Treatment modification
Immune-mediated adverse reactions
Pneumonitis/Interstitial lung disease	Grade 2	Withhold
Pneumonitis/Interstitial lung disease	Grade 3–4	Permanently discontinue
Hepatitis	ALT or AST >3 – ≤5x ULN or total bilirubin >1.5 – ≤3x ULN	Withhold
	ALT or AST >5 – ≤10x ULN	Withhold
	Concurrent ALT or AST >3x ULN and total bilirubin >2x ULN^†	Permanently discontinue
	ALT or AST >10x ULN or total bilirubin >3x ULN	Permanently discontinue
Hepatitis in HCC (or secondary tumour involvement of the liver with abnormal baseline values)^‡	ALT or AST >2.5 – ≤5x BLV and ≤20x ULN	Withhold
	ALT or AST >5–7x BLV and ≤20x ULN or concurrent ALT or AST 2.5–5x BLV and ≤20x ULN and total bilirubin >1.5 – <2x ULN^†	Withhold
	ALT or AST >10x ULN or total bilirubin >3x ULN	Permanently discontinue
Colitis or diarrhoea	Grade 2	Withhold
	Grade 3 (IMFINZI monotherapy)	Withhold
	Grade 4	Permanently discontinue
Hyperthyroidism, thyroiditis	Grade 2–4	Withhold until clinically stable
Hypothyroidism	Grade 2–4	No change to treatment
Adrenal insufficiency or hypophysitis/hypopituitarism	Grade 2–4	Withhold until clinically stable
Type 1 diabetes mellitus	Grade 2–4	No change to treatment
Nephritis	Grade 2 with serum creatinine >1.5–3x ULN (or baseline)	Withhold^†
	Grade 3 with serum creatinine >3x baseline or >3–6x ULN	Permanently discontinue
	Grade 4 with serum creatinine >6x ULN	Permanently discontinue
Rash or dermatitis (including pemphigoid)	Grade 2 for >1 week	Withhold
	Grade 3	Withhold
	Grade 4	Permanently discontinue
Myocarditis	Grade 2–4	Permanently discontinue
Myositis/polymyositis/rhabdomyolysis	Grade 2–3	Withhold^§
Myositis/polymyositis/rhabdomyolysis	Grade 4	Permanently discontinue
Myasthenia gravis	Grade 2–4	Permanently discontinue
Myelitis transverse	Any grade	Permanently discontinue
Meningitis	Grade 2	Withhold
Meningitis	Grade 3–4	Permanently discontinue
Encephalitis	Grade 2–4	Permanently discontinue
Guillain-Barré syndrome	Grade 2–4	Permanently discontinue
Other immune-mediated adverse reactions	Grade 2–3	Withhold
Other immune-mediated adverse reactions	Grade 4	Permanently discontinue
Other adverse reactions
Intestinal perforation	Any grade	Permanently discontinue
Infusion-related reactions	Grade 1–2	Interrupt or slow the rate of infusion
Infusion-related reactions	Grade 3–4	Permanently discontinue
Infection	Grade 3–4	Withhold until clinically stable
Pure red cell aplasia**	Any grade	Permanently discontinue

RESUME IMFINZI

Within 12 weeks if the adverse reactions improved to Grade ≤1 and the corticosteroid dose has been reduced to ≤10 mg prednisone or equivalent per day.

Adapted from IMFINZI Summary of Product Characteristics.³

* Common Terminology Criteria for Adverse Events, version 4.03.³
† For patients with alternative cause follow the recommendations for AST or ALT increases without concurrent bilirubin elevations.³
‡ If AST and ALT are less than or equal to ULN at baseline in patients with liver involvement, withhold or permanently discontinue IMFINZI based on recommendations for hepatitis with no liver involvement.³
§ Permanently discontinue IMFINZI if adverse reaction does not resolve to ≤Grade 1 within 30 days or if there are signs of respiratory insufficiency.³
¶ Includes immune thrombocytopenia, pancreatitis, immune-mediated arthritis, uveitis, cystitis noninfective and polymyalgia rheumatica.³
** Adverse drug reaction is only associated when olaparib maintenance treatment is used in combination with IMFINZI, following treatment with IMFINZI in combination with platinum-based chemotherapy.³
ALT – alanine aminotransferase; AST – aspartate aminotransferase; BLV – baseline value; HCC – hepatocellular carcinoma; ULN – upper limit of normal.

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.³

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.³

Do not co-administer other medicinal products through the same infusion line.³

When is administered in combination with chemotherapy, administer IMFINZI prior to chemotherapy on the same day.³

Pre-medication may also be considered for prophylaxis of subsequent infusion reactions following grade 1 or 2 reactions.³

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.³

Paediatric population

The safety and efficacy of IMFINZI in children and adolescents aged below 18 years of age has not been established regarding ES-SCLC. No data are available. For more information, please see Sections 5.1 and 5.2 of the IMFINZI Summary of Product Characteristics.³

Elderly

No dose adjustment is required for elderly patients (≥65 years of age). For more information, see Section 5.1 of the IMFINZI Summary of Product Characteristics.³

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.³

Hepatic impairment

Data from patients with severe hepatic impairment are limited. Due to minor involvement of hepatic processes in the clearance of IMFINZI 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.³

For the full of special warnings and precautions, please see Section 4.4 of the IMFINZI Summary of Product Characteristics.³

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.³

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. The safety of concurrent prophylactic cranial irradiation with IMFINZI in patients with ES-SCLC is unknown.³

Preparation

IMFINZI is supplied as a single-dose vial and does not contain any preservatives, aseptic technique must be observed.³

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 vial.³

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 solution.³

Discard any unused portion left in the vial.³

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).³

Inside is a clear-to-opalescent, colourless-to-slightly yellow solution in a Type 1 glass 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.³

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. Do not shake the vial.³

Unopened vial

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

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.³

Continue exploring the CASPIAN Regimen

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

Explore MOA

Discover more about the CASPIAN study design and efficacy outcomes

Explore efficacy data

Get to know the CASPIAN safety profile

Explore safety data

AID – autoimmune disease; ALT – alanine aminotransferase; AST – aspartate aminotransferase; ECOG – Eastern Cooperative Oncology Group; EP – etoposide + cisplatin or carboplatin; ES-SCLC – extensive-stage small-cell lung cancer; HCP – healthcare professional; IV – intravenous; NHS – National Health Service; OS – overall survival; Q3W – once every 3 weeks; Q4W – once every 4 weeks; SMC – Scottish Medicines Consortium; ULN – upper limit of normal.

NICE. Durvalumab with etoposide and either carboplatin or cisplatin for untreated extensive-stage small-cell lung cancer. https://www.nice.org.uk/guidance/ta1041 [Accessed August 2025].
SMC. Durvalumab 50 mg/mL concentrate for solution for infusion (Imfinzi®). https://scottishmedicines.org.uk/media/8945/durvalumab-imfinzi-abbreviated-final-jan-2025-for-website.pdf [Accessed August 2025].
IMFINZI Summary of Product Characteristics.
National Comprehensive Cancer Network. NCCN Guidelines for Patients: Small Cell Lung Cancer. https://www.nccn.org/patients/guidelines/content/PDF/SCLC-patient-guideline.pdf [Accessed August 2025].

GB-68888 | DOP: August 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: CASPIAN Regimen

Patients may have more time with the IMFINZI CASPIAN regimen vs EP + carboplatin or cisplatin, to enjoy what matters most³