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Advanced Solid TumorPhase 2NCT05014828

To Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Participants With Selected Solid Tumors

A Phase 2 study testing lenvatinib and Tislelizumab in people with Advanced Solid Tumor, run by BeiGene at 13 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial evaluated the safety and potential benefits of combining two cancer treatments, tislelizumab and lenvatinib, in Chinese participants with advanced or metastatic cancers, including lung, head and neck, bladder, kidney, and stomach cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
lenvatinib and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
13 sitesChina
Study dates
18 Sep 2021to 10 Jul 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants had signed an informed consent form and were able to comply with all study requirements.
  • Participants had a histologically and/or cytologically confirmed diagnosis of advanced solid tumors, which included one of the following types:
  • Non-Small Cell Lung Cancer (NSCLC)
  • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
  • Gastric Cancer (GC)
  • Urothelial Carcinoma (UC)
Show all 10Show fewer
  • Renal Cell Carcinoma (RCC)
  • Participants had at least one measurable lesion as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
  • Tumor tissue samples (approximately 10 unstained slides) were provided for central laboratory assessment of programmed death-ligand 1 (PD-L1) expression in the NSCLC cohort during the screening period. These samples were also used for retrospective exploratory biomarker analyses related to treatment response and resistance across the NSCLC, SCCHN, UC, or Gastric Cancer (GC) cohorts, in a central or designated test laboratory approved by BeiGene.
  • Participants had an Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1

Who cannot join

  • For participants in the NSCLC cohort, those with active leptomeningeal disease or uncontrolled, untreated brain metastases were excluded. In cohorts other than NSCLC, any participant with known leptomeningeal disease or brain metastases was excluded.
  • Participants who had received prior therapy with lenvatinib, or with antibodies targeting programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1), programmed death-ligand 2 (PD-L2), or any other agents specifically targeting T-cell costimulatory or immune checkpoint pathways, were excluded.
  • Participants with a history of interstitial lung disease, non-infectious pneumonitis, or any uncontrolled pulmonary conditions (including but not limited to pulmonary fibrosis or acute lung diseases) were excluded.
  • Participants who were unable to swallow capsules, or who had diseases or previous procedures that significantly affected gastrointestinal function such as malabsorption syndrome, surgical resection of the stomach or small bowel, bariatric surgery, symptomatic inflammatory bowel disease, or partial/complete bowel obstruction were excluded.
  • Participants who had experienced clinically significant bleeding (classified as Grade 2 or higher according to the Common Terminology Criteria for Adverse Events [CTCAE]) within 21 days prior to the first dose were excluded.
  • Note: Additional protocol-defined inclusion and exclusion criteria may have applied.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

China13 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Luhe Hospital, Capital Medical University

    Beijing, Beijing Municipality, 101149

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Jiangsu Province Cancer Hospital

    Nanjing, Jiangsu, 210008

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: A Multicenter, Open-label, Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors

This clinical trial evaluated the safety and potential benefits of combining two cancer treatments, tislelizumab and lenvatinib, in Chinese participants with advanced or metastatic cancers, including lung, head and neck, bladder, kidney, and stomach cancer. The study included two parts: the first part assessed how safe the drug combination was, and the second part examined how well it worked.

A small group of participants initially received the drugs to determine the appropriate dose, and if the treatment was well tolerated, additional participants were treated at that dose. Participants remained on the treatment unless their cancer progressed, they experienced serious side effects, or they chose to stop.

Keywords
Solid tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lenvatinibDrug

    Administered at the dose of 20 mg orally, once daily.

  • TislelizumabDrug

    Also called BGB-A317

    400 mg administered intravenously on Day 1 of each 42-day cycle

Study groups in NCT05014828
Study groupRoleWhat they receive
Safety Run InExperimentalParticipants with advanced or metastatic unresectable solid tumors were enrolled to receive 400 mg of tislelizumab administered on Day 1 of each 6-week cycle, along with 20 mg of lenvatinib self-administered orally once daily, to determine the recommended Part 2 dose (RP2D).
Receives: Drug: lenvatinib; Drug: Tislelizumab
Part 2: Squamous Cell Carcinoma of the Head and Neck (SCCHN) CohortExperimentalParticipants with previously untreated, advanced or metastatic SCCHN received tislelizumab (400 mg administered intravenously [IV] every 6 weeks [Q6W]) in combination with lenvatinib (20 mg taken orally once daily [QD]) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
Receives: Drug: lenvatinib; Drug: Tislelizumab
Part 2: Renal Cell Carcinoma (RCC) CohortExperimentalSystemic therapy naive participants with advanced or metastatic RCC received tislelizumab (400 mg IV Q6W) plus lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination.
Receives: Drug: lenvatinib; Drug: Tislelizumab
Part 2: Non-Small Cell Lung Cancer (NSCLC) CohortExperimentalParticipants with NSCLC expressing programmed cell death-ligand 1 (PD-L1) in ≥1% of tumor cells (TC ≥1%) and who had not received prior systemic therapy received tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early based on emerging external data.
Receives: Drug: lenvatinib; Drug: Tislelizumab
Part 2: Gastric Cancer (GC) CohortExperimentalParticipants with advanced GC who had received one prior line of systemic therapy were enrolled to receive tislelizumab and lenvatinib at the RP2D (tislelizumab 400 mg IV Q6W; lenvatinib 20 mg orally QD) until disease progression, start of new anticancer therapy, unacceptable toxicity, withdrawal of consent, or study termination; this cohort was closed early due to changes in the first-line standard of care.
Receives: Drug: lenvatinib; Drug: Tislelizumab
Part 2: Urothelial Cancer (UC) CohortExperimentalParticipants with cisplatin ineligible, systemic therapy naive advanced UC, were to be treated with tislelizumab (400 mg IV Q6W) and lenvatinib (20 mg orally QD). This cohort was closed prior to any participant enrollment based on emerging external data.
Receives: Drug: lenvatinib; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Run-in: Number of Participants With Adverse Events (AEs)

    An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug.

    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose:

    • Resulted in death
    • Was life-threatening
    • Required hospitalization or prolongation of existing hospitalization
    • Resulted in disability/incapacity
    • Was a congenital anomaly/birth defect
    • Was considered a significant medical AE by the investigator based on medical judgement.

    A dose-limiting toxicity (DLT) was defined as a Grade 3 or 4 hematologic or nonhematologic toxicity occurring during the DLT assessment window and deemed related to one or more study drugs by the investigator.

    Measured: From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose.

  2. Overall Response Rate (ORR)

    Overall response rate is defined as the percentage of participants who had a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Tumor assessments.

    CR is defined as the disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm.

    PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

Secondary outcomes (5)

  1. Progression Free Survival (PFS)

    PFS was defined as the time from randomization to the first objectively documented disease progression as assessed by the investigator per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) or death from any cause, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method.

    Measured: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

  2. Duration of Response (DOR)

    DOR was defined as the time from the first documented objective response to documented radiological disease progression as assessed by the investigator using RECIST v1.1, or death from any cause, whichever occurred first. Median DOR was estimated using the Kaplan-Meier method.

    Progressive disease is captured as at least a 20% increase in the sum of diameters of target lesions, using the smallest sum on study as the reference (including the baseline sum if it was the smallest). In addition to the 20% relative increase, the sum also had to show an absolute increase of at least 5 mm.

    Measured: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

  3. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants who demonstrated a confirmed complete response (CR), partial response (PR), or stable disease (SD) as the best overall response, in accordance with the RECIST version 1.1 criteria.

    CR was defined as the disappearance of all target and non-target lesions with no new lesions observed. Any pathological lymph nodes (whether target or non-target) were required to have a reduction in short axis to less than 10 mm.

    PR was defined as at least a 30% decrease in the sum of diameters of target lesions, using the baseline sum of diameters as the reference.

    SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), using the smallest sum of diameters recorded while on study as the reference.

    Measured: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

  4. Overall Survival (OS)

    OS was defined as the time from randomization to the documented date of death for participants who died on or before the data cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the data cutoff date were censored at their last known alive date, defined as either the clinical cutoff date for those still on treatment or the most recent available date confirming they were alive, whichever occurred first.

    Measured: From the first dose up to the primary analysis data cut-off date of 10 October 2023 (maximum time on study was 24.7 months)

  5. Number of Participants Experiencing Adverse Events (AEs)

    An adverse event refers to any unintended or unfavorable sign, symptom, or condition (including abnormal lab results) that occurs during the study, regardless of whether it is related to the study drug.

    Measured: From first dose of study drug to 30 days after last dose, up to the study completion date of 10 July 2024 (up to 32.5 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2021
  2. Study start18 Sep 2021
  3. Primary completion20 Oct 2023
  4. Study completion10 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05014828
Sponsor's protocol ID
BGB-A317-212
Other IDs
CTR20211874
Status last verified
Aug 2025
First submitted
28 Jul 2021
Last updated
24 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

Publications

  • BGB-A317-212: A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Lenvatinib in Patients With Selected Solid Tumors. Poster No: 2610 presented at ASCO, Chicago, IL, May 31-June 4, 2024

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lenvatinib and Tislelizumab in people with Advanced Solid Tumor, run by BeiGene at 13 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Run-in: Number of Participants With Adverse Events (AEs) (time frame: From first dose through the end of the safety run-in part, up to 124 days; The DLT observation period was 28 days after first dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05014828, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.

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