A study investigating what potential benefits adding AZD2811 might have to the current standard of care maintenance therapy of durvalumab in patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) who have not had any treatment yet for their cancer

2024-511887-10-00 Protocol D6132C00001 Therapeutic exploratory (Phase II) Ongoing, recruitment ended

Start 14 Sep 2021 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites · Protocol D6132C00001

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ongoing, recruitment ended
Participants planned 28
Countries 1
Sites 1

First-line patients with extensive disease small-cell lung cancer (SCLC)

To evaluate the efficacy of AZD2811 + durvalumab by assessment of the proportion of participants alive and progression free at 12 months (APF12) who have not progressed during EP-durvalumab based induction therapy

Key facts

Sponsor
AstraZeneca AB
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
14 Sep 2021 → ongoing
Decision date (initial)
2024-07-16
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
AstraZeneca AB

External identifiers

EU CT number
2024-511887-10-00
EudraCT number
2020-004091-18
ClinicalTrials.gov
NCT04745689

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacogenetic, Safety, Pharmacodynamic, Efficacy, Pharmacokinetic

To evaluate the efficacy of AZD2811 + durvalumab by assessment of the proportion of participants alive and progression free at 12 months (APF12) who have not progressed during EP-durvalumab based induction therapy

Secondary objectives 4

  1. To evaluate efficacy of AZD2811 + durvalumab: -proportion of participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18) who have not progressed during induction; -proportion of participants alive and progression free at 6 months (APF6) and 9 months (APF9) who have not progressed during induction; -assessment of Objective response rate (ORR): a.in all participants in induction, b.in participants who had not progressed during induction; -assessment of PFS in participants who had not progressed during induction; -assessment of OS in participants who had not progressed during induction
  2. To assess the safety and tolerability profile of study intervention in SCLC
  3. To evaluate the PK of durvalumab and AZD2811
  4. To evaluate the effect of AZD2811 + durvalumab on SCLC symptoms and health-related QoL using EORTC QLQ-C30 and QLQ-LC13

Conditions and MedDRA coding

First-line patients with extensive disease small-cell lung cancer (SCLC)

VersionLevelCodeTermSystem organ class
21.1 PT 10041068 Small cell lung cancer extensive stage 100000004864

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 D6132C00001
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.
 2 None Single arm: AZD2811 + durvalumab

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

  1. Documented evidence of extensive stage SCLC (ES-SCLC)
  2. Participants must be considered suitable to receive a platinum-based chemotherapy regimen, combined with durvalumab, as first-line treatment for ES-SCLC
  3. No prior exposure to immune-mediated therapy
  4. Life expectancy ≥12 weeks
  5. ECOG 0 or 1 at enrolment

Exclusion criteria 5

  1. Any history of radiotherapy to the chest prior to systemic therapy or planned consolidation chest radiation therapy
  2. Has a paraneoplastic syndrome (PNS) of autoimmune systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS
  3. Active infection including tuberculosis, HIV, hepatitis B and C
  4. Active or prior documented autoimmune or inflammatory disorders
  5. Uncontrolled intercurrent illness, including but not limited to interstitial lung disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Maintenance participants alive and progression free (APF12)

Secondary endpoints 8

  1. Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18)
  2. Maintenance participants alive and progression free at 6 months (APF6) and 9 months (APF9) using investigator assessments according to RECIST 1.1
  3. Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1
  4. Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1
  5. Overall survival (OS) in maintenance participants
  6. The safety and tolerability profile of study intervention in SCLC
  7. The pharmacokinetics of durvalumab and AZD2811
  8. Disease-related symptoms & Health-related QoL measured by EORTC QLQ-LC30 & EORTC QLQ-LC13

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

IMFINZI 50 mg/mL concentrate for solution for infusion.

PRD6651398 · Product

Active substance
Durvalumab
Substance synonyms
MEDI4736
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
99999 Week(s)
Authorisation status
Authorised
ATC code
L01XC28 — -
Marketing authorisation
EU/1/18/1322/001
MA holder
ASTRAZENECA AB
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Defosbarasertib

PRD11371322 · Product

Active substance
Defosbarasertib
Substance synonyms
2-(3-((7-(3-(ETHYL(2-HYDROXYETHYL)AMINO)PROPOXY)QUINAZOLIN-4-YL)AMINO)-1H-PYRAZOL-5-YL)-N-(3-FLUOROPHENYL)ACETAMIDE, AZD-2811, INH-34
Pharmaceutical form
SUSPENSION FOR IV INFUSION
Route of administration
INTRAVENOUS USE
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
9999999 Week(s)
Authorisation status
Not Authorised
MA holder
ASTRAZENECA AB
Paediatric formulation
No
Orphan designation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

274 Total trials 84 Recruiting 173 Ended
Commercial
Sponsor organisation
AstraZeneca AB
Address
-
City
Sodertalje
Postcode
151 85
Country
Sweden

Scientific contact point

Organisation
AstraZeneca AB
Contact name
AstraZeneca Clinical Study Information Center

Public contact point

Organisation
AstraZeneca AB
Contact name
AstraZeneca Clinical Study Information Center

Third parties 1

OrganisationCity, countryDuties
Fortrea Inc.
ORG-100012602
 Durham, United States On site monitoring, Code 11, Code 12, Code 8, Code 9

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruitment ended 3 1
Rest of world
United States, Korea, Republic of
 — 25 —

Investigational sites

Spain

1 site · Ongoing, recruitment ended
Hospital Arnau De Vilanova De Valencia
Oncology, Calle De San Clemente 12, 46015, Valencia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2021-09-14 2021-10-06 2021-12-14

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol_D6132C00001_Redacted 9.0
Protocol (for publication) D4_Patient facing documents_EORTC QLQ-C30_EN 3
Protocol (for publication) D4_Patient facing documents_EORTC QLQ-C30_ES 3.0
Protocol (for publication) D4_Patient facing documents_EORTC QLQ-LC13_EN 1
Protocol (for publication) D4_Patient facing documents_EORTC QLQ-LC13_ES 1.0
Recruitment arrangements (for publication) K_Recruitment arrangements_EU CTR Transition Study_CTIS Placeholder NA
Subject information and informed consent form (for publication) L1_D6132C00001_SIS and ICF Main_Redacted 17.0
Subject information and informed consent form (for publication) L1_D6132C00001_SIS and ICF Optional Genetic Research_Redacted 1.0
Subject information and informed consent form (for publication) L1_D6132C00001_SIS and ICF Pregnant Partner_Redacted 2.0
Synopsis of the protocol (for publication) D1_Protocol Lay Synopsis_EN_Redacted 1.0
Synopsis of the protocol (for publication) D1_Protocol Lay Synopsis_ES_Redacted 1.0

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-07-12 Spain Acceptable with conditions
2024-07-16
 2024-07-16
2 SUBSTANTIAL MODIFICATION SM-1 2024-08-12 Spain Acceptable with conditions 2024-09-06
3 SUBSTANTIAL MODIFICATION SM-2 2024-11-12 Spain Acceptable
2024-12-20
 2024-12-20
4 NON SUBSTANTIAL MODIFICATION NSM-1 2025-12-03 Spain Acceptable
2024-12-20
 2025-12-03
5 SUBSTANTIAL MODIFICATION SM-3 2025-12-15 Spain Acceptable 2026-02-09

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