Trial record 1 of 7 for:
kunlun
Study of Durvalumab Versus Placebo in Combination With Definitive Chemoradiation Therapy in Patient With ESCC (KUNLUN)
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| ClinicalTrials.gov Identifier: NCT04550260 |
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Recruitment Status :
Recruiting
First Posted : September 16, 2020
Last Update Posted : March 14, 2023
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study to assess the efficacy and safety of durvalumab administered concurrently with dCRT in patients with locally advanced, unresectable esophageal squamous cell carcinoma (ESCC).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Esophageal Squamous Cell Carcinoma | Drug: Durvalumab Drug: Placebo Drug: cisplatin + fluorouracil Drug: cisplatin + capecitabine Radiation: Radiation | Phase 3 |
Approximately 600 patients with locally advanced, unresectable ESCC (AJCC 8th cStage II-IVA) will be randomized in a 2:1 ratio to receive either durvalumab + dCRT or placebo + dCRT. The primary objectives of this study are to assess the efficacy of durvalumab + dCRT compared with placebo + dCRT in terms of progression free survival (PFS, per RECIST 1.1 as assessed by BICR) in all randomized patients (intent-to-treat [ITT] population) and PFS in patients with PD-L1 high tumors (PD-L1 High population).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | Sponsor, excluding supply chain management personnel, will remain blinded. |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Randomized, Double-Blind, Placebo Controlled, Multi-Center, International Study of Durvalumab Given Concurrently With Definitive Chemoradiation Therapy in Patients With Locally Advanced, Unresectable Esophageal Squamous Cell Carcinoma (KUNLUN) |
| Actual Study Start Date : | October 19, 2020 |
| Estimated Primary Completion Date : | November 28, 2025 |
| Estimated Study Completion Date : | November 30, 2026 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Durvalumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1: Durvalumab + definitive CRT
Durvalumab + concurrent chemoradiation
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Drug: Durvalumab
Durvalumab intravenous infusion
Other Name: MEDI4736 Drug: cisplatin + fluorouracil cisplatin + fluorouracil, as per Standard of Care Drug: cisplatin + capecitabine cisplatin + capecitabine, as per Standard of Care Radiation: Radiation 50-64Gy in total |
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Placebo Comparator: Arm 2: Placebo + definitive CRT
Placebo + concurrent chemoradiation
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Drug: Placebo
Durvalumab matching placebo for intravenous infusion Drug: cisplatin + fluorouracil cisplatin + fluorouracil, as per Standard of Care Drug: cisplatin + capecitabine cisplatin + capecitabine, as per Standard of Care Radiation: Radiation 50-64Gy in total |
Primary Outcome Measures :
- Progression free survival (PFS) per RECIST 1.1 as assessed by BICR [ Time Frame: up to approximately 56 months ]To assess the efficacy in terms of PFS in all randomized patients and in patients with PD-L1 High tumors until disease progression
Secondary Outcome Measures :
- Overall survival (OS) [ Time Frame: up to approximately 72 months ]To assess the efficacy in terms of OS in all randomized patients and in patients with PD-L1 High tumors until the date of death
Other Outcome Measures:
- Adverse events (AEs) [ Time Frame: up to approximately 72 months ]To assess the safety and tolerability profile of durvalumab + dCRT compared to placebo + dCRT in patients with ESCC
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| Ages Eligible for Study: | 18 Years to 130 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years or older at the time of signing the ICF.
- Histologically or cytologically confirmed esophageal squamous cell carcinoma, and present with locally advanced disease (Stage II-IVA).
- Unresectable or refusing surgery, and has been deemed suitable for definitive chemoradiation therapy.
- Patients with at least an evaluable lesion per RECIST 1.1.
- Mandatory provision of available tumor tissue for PD-L1 expression analysis.
- ECOG PS 0 or 1.
- Adequate organ and marrow function.
- Life expectancy of more than 3 months.
Exclusion Criteria:
- Histologically or cytologically confirmed small cell esophageal carcinoma, esophageal adenocarcinoma or other mixed carcinoma.
- Prior anti-cancer treatment for ESCC.
- Patient with a great risk of perforation and massive bleeding.
- History of allogeneic organ transplantation.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness.
- History of another primary malignancy.
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
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): NCT04550260
Contacts
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Locations
Show 167 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Principal Investigator: | Luhua Wang, MD | Cancer Hospital of Chinese Academy of Medical Science | |
| Principal Investigator: | Nabil Saba, MD | Department of Hematology and Medical Oncology, Emory University |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT04550260 |
| Other Study ID Numbers: |
D910SC00001 |
| First Posted: | September 16, 2020 Key Record Dates |
| Last Update Posted: | March 14, 2023 |
| Last Verified: | March 2023 |
| 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 rerefer 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://astrazenecagroup-dt.pharmacm.com/DT/Home |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by AstraZeneca:
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Locally Advanced Unrespectable ESCC PD-L1 Durvalumab |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Esophageal Squamous Cell Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Esophageal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases |
Gastrointestinal Diseases Cisplatin Fluorouracil Capecitabine Durvalumab Antineoplastic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents, Immunological |