Small-Cell Lung CancerPhase 2TAZMANNCT04745689
Study of AZD2811 + Durvalumab in ES-SCLC
A Phase 2 study testing Durvalumab, AZD2811 and Carboplatin in people with Small-Cell Lung Cancer, run by AstraZeneca at 12 sites in 4 countries.
Trial summary
A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Small-Cell Lung Cancer
- What is being tested?
- Durvalumab, AZD2811 and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 12 sitesin 4 countries
- Study dates
- 23 Feb 2021to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented evidence of extensive stage SCLC (ES-SCLC)
- Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
- No prior exposure to immune-mediated therapy
- Life expectancy ≥12 weeks at Day 1.
- ECOG 0 or 1 at enrolment.
Who cannot join
- Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
- Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
- Active infection including tuberculosis, HIV, hepatitis B and C
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
South Korea6 sites
Research Site
Cheongju-si, 28644
Research Site
Jinju, 52727
Research Site
Seoul, 03722
Research Site
Seoul, 05505
Research Site
Seoul, 06351
Research Site
Seoul, 06591
Poland3 sites
Research Site
Bydgoszcz, 85-796
Research Site
Olsztyn, 10-357
Research Site
Poznan, 60-693
About this study
Official title: A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction With Platinum-Based Chemotherapy Combined With Durvalumab, for the First-Line Treatment of Patients With Extensive Stage Small-Cell Lung Cancer
A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer.
Read the detailed description
Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in patients who have not progressed following induction therapy with platinum-based chemotherapy combined with durvalumab.
This is an open-label, single arm study. Patients will be treated in an induction phase with platinum-based induction therapy and durvalumab. At the end of this induction period, participants will be assessed for disease progression, per RECIST v1.1.
Participants who have not progressed per RECIST v1.1 at the end of the induction phase will roll over into the maintenance phase of the trial, where patients will commence AZD2811 and durvalumab combination.
Participants will be treated with AZD2811 and durvalumab as maintenance therapy until confirmed progressive disease, start of non-protocol defined anticancer therapy, unacceptable toxicity, or withdrawal of consent.
If study intervention is permanently discontinued, the participant will remain in the study to be evaluated for safety assessment, as well as for confirmed disease progression and for survival.
Targeted population are adult patients (aged ≥18 years) with histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC [T any, N any,M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Patients must have WHO/ECOG performance status of 0 or 1.
Tumor assessments will be performed at Screening as baseline with follow-up every 6 weeks ± 1 week for the first 36 weeks, and then every 8 weeks ±1 week until confirmed objective disease progression.
- Conditions
- Small-Cell Lung Cancer
- Being tested
- Durvalumab, AZD2811, Carboplatin, Cisplatin, Etoposide
- Keywords
- Extensive Stage Small-Cell Lung Cancer, Carcinoma, Small Cell Lung, Oat Cell Carcinoma of Lung, Oat Cell Lung Cancer, Small Cell Cancer Of The Lung, Small Cell Lung Cancer, SCLC, ES-SCLC
- Medical subject headings
- 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 Imfinzi
IV infusions through induction phase.
IV infusions through maintenance phase until PD or other discontinuation criteria.
AZD2811Drug
IV infusions through maintenance phase until PD or other discontinuation criteria.
CarboplatinDrug
IV infusions through induction phase if chosen by Investigator.
CisplatinDrug
IV infusions through induction phase if chosen by Investigator.
EtoposideDrug
IV infusions through induction phase.
| Study group | Role | What they receive |
|---|---|---|
| AZD2811 + Durvalumab | Experimental | Induction:
Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin \& Etoposide)
Maintenance:
AZD2811 + Durvalumab Receives: Drug: Durvalumab; Drug: AZD2811; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance Participants Alive and Progression Free (APF12) Per RECIST 1.1 [Efficacy]
12 month landmark PFS, APF12, where PFS is defined as the time from the first dose of study intervention in the induction phase until objective disease progression (as assessed by the investigator per RECIST v1.1) or death from any cause, whichever comes first.
Measured: Up to 12 months
Secondary outcomes (9)
Maintenance Participants Alive at 12 Months (OS12), 15 Months (OS15), and 18 Months (OS18)
12, 15, and 18 month landmarks for Overall Survival (OS) which is defined as the time from the date of first dose of study intervention in the induction phase until death due to any cause, regardless of whether the participant withdraws from study therapy or received another anticancer therapy.
Measured: Up to 18 months
Maintenance Participants Alive and Progression Free at 6 Months (APF6) and 9 Months (APF9) Using Investigator Assessments According to RECIST 1.1
6 and 9 month landmark PFS, APF6/APF9, where PFS is defined as the time from the first dose of study intervention in the induction phase until objective disease progression (as assessed by the investigator per RECIST v1.1) or death from any cause, whichever comes first.
Measured: Up to 9 months
Objective Response Rate (ORR) for All Participants Using Investigator Assessments According to RECIST 1.1
Objective response rate is defined as the percentage of participants with confirmed objective response (CR or PR) per RECIST 1.1. A confirmed response of CR/PR means that a response of CR/PR is recorded at one visit and confirmed by repeat imaging not less than 4 weeks after the visit when the response was first observed with no evidence of progression between the initial and CR/PR confirmation visit.
Measured: Up to approximately 10 months
Maintenance Participants Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1
Progression-free survival is defined as the time interval from the first dose of study intervention in the induction phase until the date of objective disease progression or death (by any cause, in the absence of progression) regardless of whether the participant withdraws from treatment or received another anticancer therapy prior to progression.
Measured: Up to approximately 10 months
Overall Survival (OS) in Maintenance Participants
Overall survival is defined as the time from the date of first dose of study intervention in the induction phase until death due to any cause regardless of whether the subject withdraws from study therapy or receives another anti-cancer therapy.
Measured: Up to approximately 13 months
AZD2811 PK: Pharmacokinetics of AZD2811 and Its Metabolites by Measuring Whole Blood Concentration
Measured: Up to Cycle 8 Day 8 (approximately 5 months)
EORTC 30: Health Related Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cancer (QLQ-C30) v3.0.
EORTC QLQ-C30 consists of 30 questions that can be combined to give 5 functional scales (physical, role, cognitive, emotional, social), 3 symptom scales (fatigue, pain, nausea/vomiting), 6 individual items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties) and a global measure of health status. QoL issues are assessed using a 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much) except 2 questions which are between 1 (Very Poor) and 7 (Excellent).
An outcome variable consisting of a score from 0 to 100 is derived for each scale/item and global health status/QoL. The variable is derived by taking the average of items contributing to a scale or the value of an item and applying a linear transformation to standardize the score, so that scores range from 0 to 100.
Higher scores on the global health status/QoL and functioning scales indicate better health status/function; higher scores on symptom scales/items represent worse symptoms.
Measured: Up to Cycle 10 Day 1, approximately 7 months
EORTC 13: Lung Cancer Specific Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Lung Cancer (QLQ-LC13) v1.0.
The EORTC QLQ-LC13 is a 13-item questionnaire comprised of 1 symptom scale assessing dysponea, and a series of single questions assessing cough, haemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, and use of pain medication.
All items are assessed using a Likert four-point scale (1= not at all to 4 = very much).
An outcome variable consisting of a score from 0 to 100 is derived for the symptom scale and symptom items according to the EORTC QLQ-LC13 instructions (Fayers et al., 2001). The outcome variable is derived by taking the average of items contributing to a scale or the value of an individual item and applying a linear transformation to standardize the score, so that scores range from 0 to 100.
Higher scores represent greater symptom severity.
Measured: Up to Cycle 10 Day 1, approximately 7 months
EORTC 13: Lung Cancer Specific Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Lung Cancer (QLQ-LC13) v1.0. Use of Pain Medication (Yes/No)
The EORTC QLQ-LC13 is a 13-item questionnaire comprised of 1 symptom scale assessing dysponea, and a series of single questions assessing cough, haemoptysis, sore mouth, dysphagis, peripheral neuropathy, alopecia, pain in chest, pain in arm or shoulder, pain in other parts, and use of pain medication. Use of pain medication is collected as a Yes/No response.
Measured: Up to Cycle 10 Day 1, approximately 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start23 Feb 2021
- Primary completion18 Jun 2022
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745689
- Sponsor's protocol ID
- D6132C00001
- Other IDs
- 2024-511887-10-00, 2020-004091-18
- Acronym
- TAZMAN
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2020
- Last updated
- 6 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction With Platinum-Based Chemotherapy Combined With Durvalumab, for the First-Line Treatment of Patients With Extensive Stage Small-Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT04745689
- Acronym / sponsor ID
- TAZMAN / D6132C00001
- Conditions
- Small-Cell Lung Cancer
- Keywords
- Extensive Stage Small-Cell Lung Cancer, Carcinoma, Small Cell Lung, Oat Cell Carcinoma of Lung, Oat Cell Lung Cancer, Small Cell Cancer Of The Lung, Small Cell Lung Cancer, SCLC, ES-SCLC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 18 Jun 2022 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Posted 27 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase II Multicenter, Open-Label, Single Arm Study to Determine the Efficacy, Safety and Tolerability of AZD2811 and Durvalumab Combination as Maintenance Therapy After Induction with Platinum-Based Chemotherapy Combined with Durvalumab, for the First-Line Treatment of Patients with Extensive Stage Small-Cell Lung Cancer.
Detailed description
Primary objective of this study is to evaluate the efficacy of AZD2811 and durvalumab in patients who have not progressed following induction therapy with platinum-based chemotherapy combined with durvalumab.
This is an open-label, single arm study. Patients will be treated in an induction phase with platinum-based induction therapy and durvalumab. At the end of this induction period, participants will be assessed for disease progression, per RECIST v1.1.
Participants who have not progressed per RECIST v1.1 at the end of the induction phase will roll over into the maintenance phase of the trial, where patients will commence AZD2811 and durvalumab combination.
Participants will be treated with AZD2811 and durvalumab as maintenance therapy until confirmed progressive disease, start of non-protocol defined anticancer therapy, unacceptable toxicity, or withdrawal of consent.
If study intervention is permanently discontinued, the participant will remain in the study to be evaluated for safety assessment, as well as for confirmed disease progression and for survival.
Targeted population are adult patients (aged ≥18 years) with histologically or cytologically documented extensive disease (American Joint Committee on Cancer Stage (7th edition) IV SCLC [T any, N any,M1 a/b]), or T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan. Patients must have WHO/ECOG performance status of 0 or 1.
Tumor assessments will be performed at Screening as baseline with follow-up every 6 weeks ± 1 week for the first 36 weeks, and then every 8 weeks ±1 week until confirmed objective disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AZD2811 + Durvalumab | Experimental | Drug: Durvalumab, Drug: AZD2811, Drug: Carboplatin, Drug: Cisplatin, Drug: EtoposideInduction: Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin \& Etoposide) Maintenance: AZD2811 + Durvalumab |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Documented evidence of extensive stage SCLC (ES-SCLC)
- Participants must be considered suitable to receive an induction platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
- No prior exposure to immune-mediated therapy
- Life expectancy ≥12 weeks at Day 1.
- ECOG 0 or 1 at enrolment.
Key exclusion criteria (5 listed)
- Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
- Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
- Active infection including tuberculosis, HIV, hepatitis B and C
- Active or prior documented autoimmune or inflammatory disorders
- Uncontrolled intercurrent illness, including but not limited to interstitial lung disease.
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: ImfinziIV infusions through induction phase. IV infusions through maintenance phase until PD or other discontinuation criteria. | Drug | AZD2811 + Durvalumab |
| AZD2811IV infusions through maintenance phase until PD or other discontinuation criteria. | Drug | AZD2811 + Durvalumab |
| CarboplatinIV infusions through induction phase if chosen by Investigator. | Drug | AZD2811 + Durvalumab |
| CisplatinIV infusions through induction phase if chosen by Investigator. | Drug | AZD2811 + Durvalumab |
| EtoposideIV infusions through induction phase. | Drug | AZD2811 + Durvalumab |
Primary outcome
Maintenance Participants Alive and Progression Free (APF12) Per RECIST 1.1 [Efficacy]
Time frame: Up to 12 months
12 month landmark PFS, APF12, where PFS is defined as the time from the first dose of study intervention in the induction phase until objective disease progression (as assessed by the investigator per RECIST v1.1) or death from any cause, whichever comes first.
9 secondary outcomes
Maintenance Participants Alive at 12 Months (OS12), 15 Months (OS15), and 18 Months (OS18)
Time frame: Up to 18 months
Maintenance Participants Alive and Progression Free at 6 Months (APF6) and 9 Months (APF9) Using Investigator Assessments According to RECIST 1.1
Time frame: Up to 9 months
Objective Response Rate (ORR) for All Participants Using Investigator Assessments According to RECIST 1.1
Time frame: Up to approximately 10 months
Maintenance Participants Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1
Time frame: Up to approximately 10 months
Overall Survival (OS) in Maintenance Participants
Time frame: Up to approximately 13 months
AZD2811 PK: Pharmacokinetics of AZD2811 and Its Metabolites by Measuring Whole Blood Concentration
Time frame: Up to Cycle 8 Day 8 (approximately 5 months)
EORTC 30: Health Related Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Cancer (QLQ-C30) v3.0.
Time frame: Up to Cycle 10 Day 1, approximately 7 months
EORTC 13: Lung Cancer Specific Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Lung Cancer (QLQ-LC13) v1.0.
Time frame: Up to Cycle 10 Day 1, approximately 7 months
EORTC 13: Lung Cancer Specific Quality of Life Based on the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire - Lung Cancer (QLQ-LC13) v1.0. Use of Pain Medication (Yes/No)
Time frame: Up to Cycle 10 Day 1, approximately 7 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- CSPLink provided by the sponsor.
- SAPLink provided by the sponsor.
- CSR SynopsisLink 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, AZD2811 and Carboplatin in people with Small-Cell Lung Cancer, run by AstraZeneca at 12 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea, Poland, Spain, United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Maintenance Participants Alive and Progression Free (APF12) Per RECIST 1.1 [Efficacy] (time frame: Up to 12 months). 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 6 Jul 2026.