Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
TREMENDOUS-2
An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
1 other identifier
interventional
114
2 countries
24
Brief Summary
This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 hepatocellular-carcinoma
Started Aug 2025
Typical duration for phase_2 hepatocellular-carcinoma
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedStudy Start
First participant enrolled
August 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 30, 2025
December 1, 2025
1.3 years
June 23, 2025
December 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS) per RECIST 1.1
Efficacy endpoint
From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed.
Secondary Outcomes (6)
Grade ≥ 3 TRAE within 6 months after the initiation of study intervention
From first dose to 6 months after the initiation of study intervention
Overall Survival (OS)
From the date of the first dose of study intervention until death due to any cause. It will be assessed when approximately 69 OS events have occurred (60% maturity), approximately 24 months after last participant has been assigned to study intervention.
Objective Response Rate (ORR) per RECIST 1.1
From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.
Disease Control Rate (DCR) per RECIST 1.1
From the date of the first dose of study intervention until the date of objective PD per RECIST 1.1. It is anticipated that this analysis will be performed approximately 8 months after the last patient has been assigned to study intervention.
Duration of response (DoR) per RECIST 1.1
From the date of response until the date of objective PD per RECIST 1.1 or death, whichever came first. It is anticipated that this analysis will be performed approximately 8 months after the last patient dosed.
- +1 more secondary outcomes
Study Arms (1)
Single Arm
EXPERIMENTALDurvalumab and Tremelimumab with Lenvatinib
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings.
- Must not have received prior systemic therapy for unresectable HCC.
- Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
- Child-Pugh Score class A.
- ECOG performance status of 0 or 1 at enrollment.
- At least 1 measurable lesion per RECSIT 1.1 guidelines
You may not qualify if:
- Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy.
- History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy.
- Clinically meaningful ascites.
- Patients with main portal vein thrombosis.
- Active or prior documented GI bleeding.
- Patient currently exhibits symptomatic or uncontrolled hypertension.
- Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV)
- Uncontrolled intercurrent illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Beijing, 100029, China
Research Site
Beijing, 100044, China
Research Site
Beijing, 100142, China
Research Site
Chengdu, 610078, China
Research Site
Chongqing, 400016, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510095, China
Research Site
Guangzhou, 510120, China
Research Site
Guangzhou, 510515, China
Research Site
Hangzhou, 310022, China
Research Site
Hefei, 230022, China
Research Site
Jinan, 250021, China
Research Site
Nanjing, 210009, China
Research Site
Nanjing, 210029, China
Research Site
Ningbo, 315010, China
Research Site
Shanghai, 200032, China
Research Site
Shanghai, 200438, China
Research Site
Taiyuan, 030001, China
Research Site
Tianjin, 300060, China
Research Site
Wenzhou, 325000, China
Research Site
Wuhan, 430030, China
Research Site
Xiamen, 361004, China
Research Site
Zhengzhou, 450052, China
Research Site
New Territories, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2025
First Posted
July 23, 2025
Study Start
August 5, 2025
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 31, 2028
Last Updated
December 30, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitment at made to the EFPIA Pharma Data Sharing Principles .For details of our timeline 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 deidentified 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 a air access. For additional details. please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient- level data from AstraZeneca group of companies sponsored clinical trials via the request portal. Plan Description: All request will be evaluated as per the Az disclosure commitment: https://astrazenecaarouptrials.pharmacm.com/ST/Submission/Disclosure Yes. indicates that Az are accepting requests for IPD ,but this does not mean are quests will be shared