A Phase 1 interventional study of SC durvalumab + rHu and IV durvalumab in Solid Tumours, sponsored by AstraZeneca. Recruiting at 19 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment
Among 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung — 16 open to participants now, 37 under way, 11 of them phase 3. durvalumab · Carcinoma, Non-Small-Cell Lung.
Among the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, this one is the 60th largest by planned enrollment, is one of 3 that started in 2026, is one of 13 in phase 1, reaches primary completion later than 27 of the 36 other live ones, and was the 93rd registered.
7,621 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,836 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →16 of the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung are open now, in 12 countries. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Ages 18+
National Cancer Institute (NCI) · Sites in United States
Ages 18+
ETOP IBCSG Partners Foundation · Sites in Australia, Austria, Belgium and 7 more countries
Ages 18+
Idris Bahce · Sites in Netherlands
Ages 18+
Second Affiliated Hospital of Guangzhou Medical University · Sites in China
Ages 18–75
By country, each count listing its studies:
durvalumab: first FDA approval 2017 (IMFINZI), first EMA approval 2018. What it is approved for, and how studies give it, is on its page →
Of the 1,327 Carcinoma, Non-Small-Cell Lung studies recruiting now, 989 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
On this site’s reading of the record, durvalumab is the treatment under test here. Read study by study →
94 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 62 · Phase 3 17 · Phase 4 2
First in 2013; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is below the median of 62 across 6,020 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 74 across the 94 interventional studies. Of the 47 that completed or were terminated, 27 (57%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 94 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,502 studies on the registry; 273 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca: 26 open now, 78 under way, 28 of them phase 3. Of 123 finished, 45 (37%) have results posted.
Among the 209 studies in Carcinoma, Non-Small-Cell Lung by AstraZeneca, this one is the 111th largest by planned enrollment of the 137 interventional ones that give a count, is one of 8 that started in 2026, is one of 36 in phase 1, reaches primary completion later than 49 of the 77 other live ones, and was the 204th registered.
AstraZeneca’s Carcinoma, Non-Small-Cell Lung studies by the year they started, since 2000.
8 of the studies testing durvalumab in Carcinoma, Non-Small-Cell Lung that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04465968Phase 3National Cancer Center Hospital EastEfficacy and Safety of CRT, Durvalumab and Surgery for SST | 2027-08-31 |
| NCT03965468ETOP IBCSG Partners FoundationImmunotherapy, Chemotherapy, Radiotherapy and Surgery for Synchronous Oligo-metastatic NSCLC | 2026-12 |
| NCT04245514Swiss Cancer InstituteMultimodality Treatment in Stage III Non-small Cell Lung Cancer (NSCLC) | 2026-12-07 |
| NCT06908070Idris BahceChemoradiotherapy With Surgery Followed by Consolidation Durvalumab | 2026-12-17 |
| NCT05206812Yonsei UniversityWindow of Opportunity Trial of Durvalumab (MEDI4736) to Identify Immune Dynamics in Operable Non-small Cell Lung Cancer (NSCLC) (MIRACLE) | 2027-01 |
Add all 8 to your calendar (.ics) → With an account.
Among the 94 studies testing durvalumab in Carcinoma, Non-Small-Cell Lung, from their registry updates:
Among AstraZeneca’s 209 in Carcinoma, Non-Small-Cell Lung:
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).
This is a Phase I, multicentre study that will consist of 2 parts -
Part 1 may include participants with solid tumours - non-small cell lung cancer (NSCLC), hepatocellular carcinoma (HCC) or limited-stage small cell lung cancer (LS-SCLC). It will further consist of 2 planned dose levels of SC durvalumab - Dose level 1 (DL1) and Dose level 2 (DL2).
Part 2 will include participants with unresectable HCC. It will be initiated once a dose has been identified based on Part 1.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part 1 only:
Locally Advanced Unresectable (Stage III) NSCLC Participants -
LS-SCLC Participants -
Part 1 and 2:
Unresectable HCC Participants -
Exclusion Criteria:
Part 1 only:
Locally Advanced Unresectable (Stage III) NSCLC Participants -
LS SCLC Participants -
Part 1 and 2:
Unresectable HCC Participants -
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive DL1 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Drug: SC durvalumab + rHu · Drug: IV durvalumab · Drug: Tremelimumab
Participants will receive DL2 of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Drug: SC durvalumab + rHu · Drug: IV durvalumab · Drug: Tremelimumab
Participants will receive dose level X (determined from data analysis in Part 1) of SC durvalumab + rHu followed by IV durvalumab at predefined intervals.
Drug: SC durvalumab + rHu · Drug: IV durvalumab · Drug: Tremelimumab
Durvalumab + rHu will be administered subcutaneously.
Durvalumab will be administered intravenously.
Also known as: MEDI4736
Tremelimumab will be administered to participants with unresectable HCC as an IV infusion.
Area under the concentration-time curve
To characterise the AUC of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Observed lowest concentration before the next dose is administered (Ctrough)
To characterise the Ctrough of SC durvalumab
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Area under the concentration-time curve from time 0 to last quantifiable concentration (AUClast)
To characterise the AUClast of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Maximum observed concentration (Cmax)
To characterise the Cmax of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Time to reach maximum concentration following drug administration (tmax)
To characterise the tmax of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Terminal elimination half-life (t1/2λz)
To characterise the t1/2λz of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Total body clearance/apparent total body clearance (CL[/F])
To characterise the CL(/F) of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Apparent volume of distribution based on the terminal phase volume (Vz[/F])
To characterise the VZ(/F) of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Average drug concentration over a dosing interval (Cavg)
To characterise the Cavg of SC durvalumab.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Serum concentration of durvalumab
To characterise the serum concentration of SC durvalumab at specified timepoints.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of durvalumab (approximately 17 months).
Number of participants with adverse events (AEs)
To assess the safety and tolerability of SC durvalumab.
Time frame: Up to Survival Follow-up (approximately 17 months)
Number of participants with dose-limiting toxicities (DLTs)
To assess the safety and tolerability of SC durvalumab.
Time frame: Up to Survival Follow-up (approximately 17 months)
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Not enrolling at this site.
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
Started Mar 2026 (actual). Primary completion is estimated for Aug 2027, 16 months after the start.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's planned 16 months is below that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Durvalumab
Carcinoma, Non-Small-Cell Lung →