Study of AZD2811 + Durvalumab in ES-SCLC (TAZMAN)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04745689 |
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Recruitment Status :
Active, not recruiting
First Posted : February 9, 2021
Last Update Posted : February 21, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Small-Cell Lung Cancer | Drug: Durvalumab Drug: AZD2811 Drug: Carboplatin Drug: Cisplatin Drug: Etoposide | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 31 participants |
| Allocation: | Non-Randomized |
| 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 : | March 31, 2023 |
| Estimated Study Completion Date : | October 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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. |
- Maintenance participants alive and progression free (APF12) per RECIST 1.1 [Efficacy] [ Time Frame: Up to 12 months ]
- 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: Approximately 3 years ]
- Maintenance participants Progression-free survival (PFS) using investigator assessments according to RECIST 1.1 [ Time Frame: Approximately 3 years ]
- Overall survival (OS) in maintenance participants [ Time Frame: Approximately 3 years ]
- 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
- Cmin of durvalumab [ Time Frame: Predose Maintenance Day 1 of Cycles 5 and 7 (up to approximately 3 years) ]
- Cmax of durvalumab [ Time Frame: Predose Maintenance Day 1 of Cycles 5 and 7 (up to approximately 3 years) ]
- AZD2811 PK: Pharmacokinetics of AZD2811 and its metabolites by measuring whole blood concentration [ Time Frame: Approximately 3 years ]
- 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).
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| United States, Michigan | |
| Research Site | |
| Grand Rapids, Michigan, United States, 49503 | |
| Korea, Republic of | |
| Research Site | |
| Cheongju-si, Korea, Republic of, 28644 | |
| Research Site | |
| Jinju-si, Korea, Republic of, 52727 | |
| Research Site | |
| Seoul, Korea, Republic of, 03722 | |
| Research Site | |
| Seoul, Korea, Republic of, 06591 | |
| Research Site | |
| Seoul, Korea, Republic of, 138-736 | |
| Research Site | |
| Seoul, Korea, Republic of, 6351 | |
| Poland | |
| Research Site | |
| Bydgoszcz, Poland, 85-796 | |
| Research Site | |
| Olsztyn, Poland, 10-357 | |
| Research Site | |
| Poznan, Poland, 60-693 | |
| Spain | |
| Research Site | |
| Sevilla, Spain, 41071 | |
| Research Site | |
| Valencia, Spain, 46015 | |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT04745689 |
| Other Study ID Numbers: |
D6132C00001 |
| First Posted: | February 9, 2021 Key Record Dates |
| Last Update Posted: | February 21, 2022 |
| Last Verified: | February 2022 |
| 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/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |
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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 |