Study of AZD2811 + Durvalumab in ES-SCLC

NCT04745689 | Active Not Recruiting Phase 2 Results FDA Drug

• 3 other identifiers: D6132C000012024-511887-10-002020-004091-18
• Study Type: interventional
• Target: 31
• Locations: 4 countries
• Sites: 12

Brief 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 Cancer.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 months

Secondary Outcomes (9)

• Maintenance Participants Alive at 12 Months (OS12), 15 Months (OS15), and 18 Months (OS18)

  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

  Up to 9 months

• Objective Response Rate (ORR) for All Participants Using Investigator Assessments According to RECIST 1.1

  Up to approximately 10 months

• Maintenance Participants Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1

  Up to approximately 10 months

• Overall Survival (OS) in Maintenance Participants

  Up to approximately 13 months

Study Arms (1)

AZD2811 + Durvalumab

EXPERIMENTAL

Induction: Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin \& Etoposide) Maintenance: AZD2811 + Durvalumab

Drug: Durvalumab; Drug: AZD2811; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide

Interventions

Durvalumab DRUG

IV infusions through induction phase. IV infusions through maintenance phase until PD or other discontinuation criteria.

Also known as: Imfinzi

AZD2811 + Durvalumab

AZD2811 DRUG

IV infusions through maintenance phase until PD or other discontinuation criteria.

AZD2811 + Durvalumab

Carboplatin DRUG

IV infusions through induction phase if chosen by Investigator.

AZD2811 + Durvalumab

Cisplatin DRUG

IV infusions through induction phase if chosen by Investigator.

AZD2811 + Durvalumab

Etoposide DRUG

IV infusions through induction phase.

AZD2811 + Durvalumab

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

Research Site

Grand Rapids, Michigan, 49503, United States

Location

Research Site

Bydgoszcz, 85-796, Poland

Location

Research Site

Olsztyn, 10-357, Poland

Location

Research Site

Poznan, 60-693, Poland

Location

Research Site

Cheongju-si, 28644, South Korea

Location

Research Site

Jinju, 52727, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 05505, South Korea

Location

Research Site

Seoul, 06351, South Korea

Location

Research Site

Seoul, 06591, South Korea

Location

Research Site

Seville, 41071, Spain

Location

Research Site

Valencia, 46015, Spain

Location

Related Links

• CSP
• SAP
• CSR Synopsis

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

durvalumab; AZD2811; Carboplatin; Cisplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Limitations and Caveats

Enrolment to Study D6132C00001 was terminated prior to completion of the study due to the evolving benefit-risk profile of AZD2811 not supporting further development for the first-line treatment of patients with extensive stage small-cell lung cancer (ES-SCLC). Due to the early termination of the study, only 9 participants (of the planned 80 participants) received maintenance treatment with AZD2811 in combination with durvalumab and data collection for these participants was limited.

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: February 9, 2021
• Study Start: February 23, 2021
• Primary Completion: June 18, 2022
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 24, 2026
• Results First Posted: March 27, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer 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 de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

PL (3); KR (6); ES (2); US (1)