Non-Small Cell Lung CancerPhase 1SCope-D1NCT04870112
A Study to Evaluate Subcutaneous Durvalumab in Patients With Non-Small Cell Lung Cancer and Small Cell Lung Cancer
A Phase 1 study testing Durvalumab, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by AstraZeneca at 8 sites in 4 countries.
Trial summary
This study has 2 parts: dose finding and dose confirmatory. In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- What is being tested?
- Durvalumab, Cisplatin and Carboplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 28 Jun 2021to 30 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC
- ECOG performance status of 0 or 1
- For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline
- Absence of EGFR mutation or ALK rearrangement prior to screening
Who cannot join
- History of allogeneic organ transplantation
- Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome
- Uncontrolled intercurrent illness
- History of another primary malignancy
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Show all 9Show fewer
- Brain metastases or spinal cord compression
- Persistent toxicities (CTCAE Grade >2) caused by previous anticancer therapy, excluding alopecia
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Taiwan3 sites
Research Site
Taichung, 40705
Research Site
Taipei, 11217
Research Site
Taipei, 114
United States2 sites
Research Site
Fairfax, Virginia, 22031
Research Site
Houston, Texas, 77090
About this study
Official title: A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
This study has 2 parts: dose finding and dose confirmatory.
In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up
Read more
In Part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally, up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period.
AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- Being tested
- Durvalumab, Cisplatin, Carboplatin, Etoposide
- Keywords
- imfinzi, durvalumab
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called MEDI4736, IMFINZI
Anti-PD-L1 antibody
CisplatinDrug
Chemotherapy
CarboplatinDrug
Chemotherapy
EtoposideDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with NSCLC | Experimental | Patients with Non-Small Cell Lung Cancer Receives: Drug: Durvalumab |
| Patients with SCLC | Experimental | Patients with Small Cell Lung Cancer Receives: Drug: Durvalumab; Drug: Cisplatin; Drug: Carboplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observed serum concentration (Ctrough)
Measured: Approximately 16 months
Number of patients with injection site reactions and immune-mediated reactions
Measured: Approximately 16 months
Maximum observed serum concentration (Cmax)
Measured: Approximately 16 months
Secondary outcomes (14)
Time to maximum observed serum concentration (tmax) of durvalumab
Measured: Approximately 16 months
Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab
Measured: Approximately 16 months
Incidence of Adverse Events
Measured: Approximately 16 months
Changes in WHO/ECOG performance status
Measured: Approximately 16 months
Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
Measured: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry
Clinical chemistry will be assessed by liver function(Alanine aminotransferase, Aspartate aminotransferase, albumin, total bilirubin), kidney function (e.g. Urea, Creatinine) and endocrine function(TSH, T3 free,T4 free)
Measured: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology
Hematology will be assessed by white cell count, platelet count, absolute neutrophil count and absolute lymphocyte count.
Measured: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)
Measured: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (pulse rate) in beats per minute
Measured: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (respiration rate) in breaths per minute
Measured: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius
Measured: Approximately 16 months
Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
Measured: Approximately 16 months
Part 2 only: Overall Response Rate (ORR) - proportion of participants with a complete or partial response to treatment as determined using RECIST 1.1 guidelines
Measured: Approximately 16 months
Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
Measured: Approximately 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start28 Jun 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Why it stopped: AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suli Bolus, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870112
- Sponsor's protocol ID
- D9072C00001
- Other IDs
- 2020-006041-18
- Acronym
- SCope-D1
- Status last verified
- Feb 2024
- First submitted
- 16 Apr 2021
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a, Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of Subcutaneous Durvalumab in Patients With Non-Small Cell and Small Cell Lung Cancer - SCope-D1
- ClinicalTrials.gov ID
- NCT04870112
- Acronym / sponsor ID
- SCope-D1 / D9072C00001
- Conditions
- Non-Small Cell Lung Cancer, Small Cell Lung Cancer
- Keywords
- imfinzi, durvalumab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has 2 parts: dose finding and dose confirmatory.
In Part 1, the dose finding phase of the study, there will be 3 or more dosing levels to find out what dose of durvalumab administered as an infusion under the skin acts similarly to durvalumab administered into a vein. 24 participants with Non-Small Cell Lung Cancer will be enrolled for a 12 month treatment period and 3 months follow up
In Part 2, the dose confirmation phase of the study, participants will receive the dose of durvalumab identified in Part 1 of the study. The goal of Part 2 will be to learn more about the way that the body processes durvalumab when administered as an infusion under the skin. Approximately 90 participants with Non-Small Cell Lung Cancer will be enrolled; additionally, up to 10 participants with Small Cell Lung Cancer (who will receive concurrent chemotherapy) will be enrolled for a 12 treatment period and a 3 month follow-up period.
AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 (Phase I) completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 (Phase II) was not initiated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with NSCLC | Experimental | Drug: DurvalumabPatients with Non-Small Cell Lung Cancer |
| Patients with SCLC | Experimental | Drug: Durvalumab, Drug: Cisplatin, Drug: Carboplatin, Drug: EtoposidePatients with Small Cell Lung Cancer |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically documented unresectable Stage III NSCLC that has not progressed following definitive platinum based CRT or extensive disease (Stage IV) SCLC
- ECOG performance status of 0 or 1
- For participants with SCLC: At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 TL at baseline
- Absence of EGFR mutation or ALK rearrangement prior to screening
Key exclusion criteria (9 listed)
- History of allogeneic organ transplantation
- Autoimmune or inflammatory disorders, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome
- Uncontrolled intercurrent illness
- History of another primary malignancy
- History of active primary immunodeficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: MEDI4736, IMFINZIAnti-PD-L1 antibody | Drug | Patients with NSCLC, Patients with SCLC |
| CisplatinChemotherapy | Drug | Patients with SCLC |
| CarboplatinChemotherapy | Drug | Patients with SCLC |
| EtoposideChemotherapy | Drug | Patients with SCLC |
Primary outcome
Observed serum concentration (Ctrough)
Time frame: Approximately 16 months
Number of patients with injection site reactions and immune-mediated reactions
Time frame: Approximately 16 months
Maximum observed serum concentration (Cmax)
Time frame: Approximately 16 months
14 secondary outcomes
Time to maximum observed serum concentration (tmax) of durvalumab
Time frame: Approximately 16 months
Area under the Plasma Concentration versus Time Curve (AUCτ) of durvalumab
Time frame: Approximately 16 months
Incidence of Adverse Events
Time frame: Approximately 16 months
Changes in WHO/ECOG performance status
Time frame: Approximately 16 months
Occurrence of abnormal ECG - PR, QRS, QT, and QT interval corrected by Fridericia's formula intervals
Time frame: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in clinical chemistry
Time frame: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by abnormality in haematology
Time frame: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (blood pressure in mmHg)
Time frame: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (pulse rate) in beats per minute
Time frame: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (respiration rate) in breaths per minute
Time frame: Approximately 16 months
Safety and tolerability of SC dosing of durvalumab in participants with unresectable stage III NSCLC as assessed by vital signs (temperature) in degrees Celsius
Time frame: Approximately 16 months
Incidence of of anti-drug antibodies (ADA) and neutralizing antibodies
Time frame: Approximately 16 months
Part 2 only: Overall Response Rate (ORR) - proportion of participants with a complete or partial response to treatment as determined using RECIST 1.1 guidelines
Time frame: Approximately 16 months
Part 2 only: Best Objective Response (BoR) - participant's best response following first dose of study drug
Time frame: Approximately 16 months
Results and safety
The study was stopped early (reason given: AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- AstraZenecaClinicaltrials.comLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suli Bolus, MD study director
AstraZeneca
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Durvalumab, Cisplatin and Carboplatin in people with Non-Small Cell Lung Cancer and Small Cell Lung Cancer, run by AstraZeneca at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Taiwan, United States, Spain, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: AstraZeneca has decided to stop further enrollment and the study was terminated when all patients in Part 1 completed their last study visit. No safety issues or clinical concerns however, have been identified for this study. Part 2 was not initiated). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observed serum concentration (Ctrough) (time frame: Approximately 16 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.