Welcome to this UK AstraZeneca produced and funded website
This website is intended for UK Healthcare Professionals only.
The website contains both promotional and non-promotional content.
If you are a patient or a carer of a patient prescribed an AstraZeneca product, please visit myazmed.co.uk
For any other UK residents please visit astrazeneca.co.uk
This website is intended for UK Healthcare professionals only. Other UK residents please visit astrazeneca.co.uk
ADRIATIC is a randomised, double‑blind, placebo‑controlled, multicentre phase III study in 730 patients with histologically or cytologically confirmed LS‑SCLC (Stage I to III) who had not progressed following concurrent chemoradiation therapy.* Patients had a WHO/ECOG performance status of 0 or 1, and Stage I or II patients had to be medically inoperable, as determined by the investigator.†1,6
†The ADRIATIC study evaluated the efficacy of IMFINZI monotherapy (n=264) and the combination of IMFINZI and an unlicensed combination therapy (n=200) vs placebo alone (n=266) as a consolidation treatment in patients with LS-SCLC. Randomisation was stratified by stage (I/II vs. III) and receipt of PCI (yes vs. no).1
‡ The radiotherapy component must have been initiated no later than the end of Cycle 2 of chemotherapy and consist of either 60 to 66 Gy over 6 weeks (standard once-daily schedule) or 45 Gy over 3 weeks (hyperfractionated twice-daily schedule).1,6
§ Once 600 patients were randomised, subsequent patients were randomised 1:1 between only the IMFINZI monotherapy and placebo arms. Therapy with IMFINZI and unlicensed combination therapy was an investigational approach, and the data from that arm is not being presented. Patients in the IMFINZI and cCRT alone arms were administered an unlicensed medicine placebo for the first 4 cycles.1,6
¶Placebo=cCRT alone
IMFINZI was evaluated in patients who had not progressed following up to 4 cycles of definitive, platinum-based cCRT completed within 1 to 42 days prior to randomisation.1,6
Demographics and baseline disease characteristics were well balanced between study arms and included on average:1
| IMFINZI (n=264) | Placebo (n=266) | |
|---|---|---|
| Median age (range) – yr | 62 (28–84) | 62 (28–79) |
| Male sex – no. (%) | 178 (67.4) | 188 (70.7) |
| Race – no. (%)† | ||
| White | 130 (49.2) | 137 (51.5) |
| Asian | 131 (49.6) | 121 (45.5) |
| Black | 1 (0.4) | 3 (1.1) |
| Other | 2 (0.8) | 5 (1.9) |
| Geographic region – no. (%)†† | ||
| Asia | 129 (48.9) | 120 (45.1) |
| Europe | 94 (35.6) | 112 (42.1) |
| North or South America | 41 (15.5) | 34 (12.8) |
| WHO performance-status score – no. (%)¶ | ||
| 0 | 132 (50.0) | 126 (47.4) |
| 1 | 132 (50.0) | 140 (52.6) |
| Former or current smoker – no. (%) | 241 (91.3) | 240 (90.2) |
| Tumour-node-metastasis stage at diagnosis – no. (%)§ | ||
| I or II | 33 (12.5) | 34 (12.8) |
| III | 231 (87.5) | 232 (87.2) |
| Previous concurrent chemoradiotherapy – no. (%) | ||
| Chemotherapy regimen in first cycle | ||
| Cisplatin–etoposide | 173 (65.5) | 178 (66.9) |
| Carboplatin–etoposide | 91 (34.5) | 88 (33.1) |
| Radiotherapy fractionation schedule | ||
| Once daily | 195 (73.9) | 187 (70.3) |
| Twice daily | 69 (26.1) | 79 (29.7) |
| Best response | ||
| Complete response | 31 (11.7) | 34 (12.8) |
| Partial response | 191 (72.3) | 200 (75.2) |
| Stable disease | 42 (15.9) | 32 (12.0) |
| Time from end of previous concurrent chemoradiotherapy to randomisation – no. (%) | ||
| <14 days | 32 (12.1) | 32 (12.0) |
| 14 to <28 days | 79 (29.9) | 80 (30.1) |
| ≥28 days | 153 (58.0) | 154 (57.9) |
| Receipt of prophylactic cranial irradiation before randomisation – no. (%)§ | 142 (53.8) | 143 (53.8) |
Adapted from Cheng Y, et al. New England Journal of Medicine 2024.6
* The intention-to-treat population included all patients who underwent randomisation. Percentages may not total 100 because of rounding.6
†Race was self-reported.6
†† Asia included China, India, Japan, South Korea, Taiwan, and Vietnam. Europe included Belgium, the Czech Republic, Germany, Italy, the Netherlands, Poland, Russia, Spain, Turkey, and the United Kingdom. North America included Canada and the United States, and South America included Argentina.6
¶ World Health Organization (WHO) performance-status scores range from 0 to 5, with higher scores indicating greater disability. Data shown are for the last WHO performance-status score recorded before or on the day of randomisation.6
§ This characteristic was a stratification factor, as recorded in the electronic case-report form.6
Hear Dr Huiqi Yang, Consultant Clinical Oncologist, Cambridge University Hospitals NHS Foundation Trust provide an overview of the ADRIATIC regimen and share her clinical insights.
All statements and opinions expressed in this video are those of the individual speaker and are based on their own personal experience.
IMFINZI following cCRT demonstrated 22.5 months improvement in mOS vs. placebo6
*OS subgroup analysis was not powered to show differences between or within individual subgroups, and was not tested for statistical significance.6
IMFINZI following cCRT demonstrated 7.4 months improvement in mPFS vs. placebo
*PFS subgroup analysis was not powered to show differences between or within individual subgroups and was not tested for statistical significance.6
The NICE recommended and SMC accepted ADRIATIC Regimen offers a flexible treatment solution tailored to patient needs as IMFINZI can be initiated after either sequential or concurrent chemoradiotherapy, with flexibility in radiotherapy dosing and the use of PCI.1,2,4,6
Post-hoc analyses of OS, PFS and safety profile with durvalumab versus placebo, in prespecified subgroups of patients defined by PCI use and prior cCRT-related variables:7
*The components and delivery of standard of care may vary based on patient characteristics and region.
†If disease control was achieved and no additional benefit was expected with an additional cycle of CT, in the opinion of the investigator.
‡RT must commence no later than end of cycle 2 of CT.
§Based on the first cycle of CT.7
For each subgroup, hazard ratios (HRs) for IMFINZI vs placebo were calculated from an unstratified multivariable Cox proportional hazards model with a treatment-by-subgroup (PCI, CT, or RT) interaction term that was adjusted for PCI, CT, RT, time from cCRT to randomisation, response to cCRT, age, sex, WHO PS, and disease stage.7
*Subgroup HRs and CIs calculated using unstratified Cox proportional hazards model.
†ITT HR and CIs calculated using a Cox proportional hazards model stratified by TNM stage and receipt of PCI.
‡Multivariable analysis interaction p-value 0.96.7
*Subgroup HRs and CIs calculated using unstratified Cox proportional hazards model.
†ITT HR and CIs calculated using a Cox proportional hazards model stratified by TNM stage and receipt of PCI.
‡Multivariable analysis interaction p-value 0.50.7
Rates of maximum grade 3-4 treatment-emergent adverse events (TEAEs) were higher in PCI-yes vs PCI-no and carboplatin vs cisplatin subgroups7
The NICE recommended and SMC accepted ADRIATIC regimen offers the option of PCI alongside sCRT or cCRT1,2,4,6
Hear Dr Huiqi Yang, Consultant Clinical Oncologist, Cambridge University Hospitals NHS Foundation Trust share her insights on the practicalities of delivering PCI in a real-world setting.
All statements and opinions expressed in this video are those of the individual speaker and are based on their own personal experience.
ADRIATIC indication: IMFINZI as monotherapy is indicated for the treatment of adults with limited-stage small-cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemoradiation therapy.1
CASPIAN indication: 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).1
NICE recommends durvalumab can be used, within its marketing authorisation, as an option to treat limited-stage small-cell lung cancer that has not progressed after platinum-based chemoradiotherapy in adults. Durvalumab can only be used if the company provides it according to the commercial arrangement.²
SMC has accepted durvalumab for treating adults with limited-stage small-cell lung cancer (LS-SCLC). It is used in patients whose disease has not got worse after platinum-based chemoradiation therapy (chemotherapy and radiotherapy given at the same time).4
†Based on interim analysis.6
‡Based on exploratory analysis. Interim (primary) analysis results demonstrated mOS was significantly longer in the IMFINZI + EP group (mOS: 13.0 months
[95% CI: 11.5–14.8]) than the EP group (mOS: 10.3 months [95% CI: 9.3–11.2]) [HR=0.73 (95% CI: 0.59-0.91) p=0.0047].8
Learn more about the dosing details in the ADRIATIC Regimen
Take a closer look at how IMFINZI works within the ADRIATIC Regimen
Get to know the ADRIATIC safety profile
BID, twice a day; cCRT, concurrent chemoradiation therapy; CD80, cluster of differentiation 80; CI, confidence interval; CR, complete response; CRT, chemoradiotherapy; ECOG, Eastern Cooperative Oncology Group; ES-SCLC, extensive-stage small-cell lung cancer; Gy, gray; HR, hazard ratio; IO, immunotherapy; ITT, intention to treat; LS-SCLC, limited-stage small-cell lung cancer; mOS, median overall survival; mPFS, median progression-free survival; ORR, objective response rate; OS, overall survival; PCI, prophylactic cranial irradiation; PD-1, programmed cell death 1; PD-L1, programmed death-ligand 1; PFS, progression-free survival; PR, partial response; PS, performance status; Q4W, once every 4 weeks; QD, once daily; RECIST, Response Evaluation Criteria in Solid Tumours; RT, radiotherapy; SAEs, serious adverse events; SCLC, small-cell lung cancer; SD, stable disease; TEAE, treatment-emergent adverse events; TNM, tumour-node-metastasis; yr, year.
GB-76773 | DOP: October 2026
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.
This website was created for UK HCPs and has been designed to provide information to educate, empower and enable them in the great work they are doing for patients across a range of therapy areas. This website is intended for doctors, nurses, and pharmacists in the UK. Other UK residents please visit astrazeneca.co.uk.
GB-74216| DOP : February 2026
