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Study of AZD2811 + Durvalumab in ES-SCLC (TAZMAN)

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ClinicalTrials.gov Identifier: NCT04745689
Recruitment Status : Recruiting
First Posted : February 9, 2021
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Small-Cell Lung Cancer Drug: Durvalumab Drug: AZD2811 Drug: Carboplatin Drug: Cisplatin Drug: Etoposide Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : August 10, 2023
Estimated Study Completion Date : March 11, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab

Arm Intervention/treatment
Experimental: AZD2811 + Durvalumab

Induction:

Durvalumab + Platinum Chemotherapy (Carboplatin or cisplatin & Etoposide)

Maintenance:

AZD2811 + Durvalumab

Drug: Durvalumab

IV infusions through induction phase.

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

Other Name: Imfinzi

Drug: AZD2811
IV infusions through maintenance phase until PD or other discontinuation criteria.

Drug: Carboplatin
IV infusions through induction phase if chosen by Investigator.

Drug: Cisplatin
IV infusions through induction phase if chosen by Investigator.

Drug: Etoposide
IV infusions through induction phase.




Primary Outcome Measures :
  1. Maintenance participants alive and progression free (APF12) per RECIST 1.1 [Efficacy] [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Maintenance participants alive at 12 months (OS12), 15 months (OS15), and 18 months (OS18) [ Time Frame: Up to 18 months ]
  2. 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 ]
  3. Objective response rate (ORR) for all participants using investigator assessments according to RECIST 1.1 [ Time Frame: Approximately 3 years ]
  4. Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1 [ Time Frame: Approximately 3 years ]
  5. Overall survival (OS) in maintenance participants [ Time Frame: Approximately 3 years ]
  6. Assess safety and tolerability profile in terms safety assessments, adverse events per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event [CTCAE] v5.0, and dose modifications [ Time Frame: Approximately 3 years ]
    Incidence of adverse events as measured by CTCAE 5.0

  7. Cmin of durvalumab [ Time Frame: Predose Maintenance Day 1 of Cycles 5 and 7 (up to approximately 3 years) ]
  8. Cmax of durvalumab [ Time Frame: Predose Maintenance Day 1 of Cycles 5 and 7 (up to approximately 3 years) ]
  9. AZD2811 PK: Pharmacokinetics of AZD2811 and its metabolites by measuring whole blood concentration [ Time Frame: Approximately 3 years ]
  10. 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: Approximately 3 years ]

    The EORTC QLQ-C30 consists of 30 questions that can be combined to produce 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea/vomiting), 6 individual items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties), and a global measure of health status. The EORTC QLQ-C30 will be scored according to the EORTC QLQ-C30 Scoring Manual.

    Quality of life issues are assessed using a four-point scale (1= not at all, 2 = a little, 3 = quite a bit, 4 = very much), apart from two questions which are measured between 1 (Very Poor) to 7 (Excellent).


  11. 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: Approximately 3 years ]

    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. All items are assessed using a Likert four-point scale (1= not at all to 4 = very much).

    Scoring will be done according to the EORTC QLQ-C30 Scoring Manual (Fayers et al., 2001). A high score for a symptom scale or single item represents a high level of symptomology or problems.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04745689


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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United States, Connecticut
Research Site Withdrawn
New Haven, Connecticut, United States, 06510
United States, Georgia
Research Site Recruiting
Atlanta, Georgia, United States, 30318
Research Site Withdrawn
Atlanta, Georgia, United States, 30322
United States, Kentucky
Research Site Recruiting
Louisville, Kentucky, United States, 40217
United States, Massachusetts
Research Site Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site Recruiting
Grand Rapids, Michigan, United States, 49503
United States, Ohio
Research Site Not yet recruiting
Cleveland, Ohio, United States, 44106
Research Site Withdrawn
Columbus, Ohio, United States, 43210
United States, Tennessee
Research Site Withdrawn
Nashville, Tennessee, United States, 37203
Research Site Withdrawn
Nashville, Tennessee, United States, 37212
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Virginia
Research Site Withdrawn
Fairfax, Virginia, United States, 22003
Australia
Research Site Not yet recruiting
North Gosford, Australia, 2250
Research Site Not yet recruiting
Wollongong, Australia, 2500
Canada, Quebec
Research Site Not yet recruiting
Montreal, Quebec, Canada, H2X 0A9
Germany
Research Site Not yet recruiting
Braunschweig, Germany, 38114
Research Site Not yet recruiting
Esslingen, Germany, 73730
Research Site Withdrawn
Großhansdorf, Germany, 22927
Research Site Not yet recruiting
Hamburg, Germany, 21075
Research Site Not yet recruiting
Immenhausen, Germany, 34376
Research Site Not yet recruiting
Luebeck, Germany, 23538
Research Site Not yet recruiting
Regensburg, Germany, 93053
Italy
Research Site Withdrawn
Milano, Italy, 20132
Research Site Withdrawn
Orbassano, Italy, 10043
Research Site Withdrawn
Rome, Italy, 168
Research Site Withdrawn
Verona, Italy, 37124
Korea, Republic of
Research Site Recruiting
Cheongju-si, Korea, Republic of, 28644
Research Site Recruiting
Jinju-si, Korea, Republic of, 660-702
Research Site Recruiting
Seoul, Korea, Republic of, 03722
Research Site Recruiting
Seoul, Korea, Republic of, 06591
Research Site Recruiting
Seoul, Korea, Republic of, 138-736
Research Site Recruiting
Seoul, Korea, Republic of, 6351
Poland
Research Site Not yet recruiting
Bydgoszcz, Poland, 85-796
Research Site Suspended
Gdynia, Poland, 81-519
Research Site Not yet recruiting
Olsztyn, Poland, 10-357
Research Site Not yet recruiting
Poznan, Poland, 60-693
Research Site Suspended
Warszawa, Poland, 02-781
Spain
Research Site Recruiting
Barcelona, Spain, 08003
Research Site Not yet recruiting
Barcelona, Spain, 08035
Research Site Recruiting
Madrid, Spain, 28007
Research Site Recruiting
Madrid, Spain, 28027
Research Site Not yet recruiting
Madrid, Spain, 28041
Research Site Recruiting
Pozuelo de Alarcón, Spain, 28223
Research Site Recruiting
Sevilla, Spain, 41071
Research Site Not yet recruiting
Valencia, Spain, 46010
Research Site Recruiting
Valencia, Spain, 46015
Sponsors and Collaborators
AstraZeneca
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT04745689    
Other Study ID Numbers: D6132C00001
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: October 5, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
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
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carboplatin
Etoposide
Durvalumab
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological