Non-small Cell Lung CancerPhase 2NCT05635708
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
A Phase 2 study testing Tislelizumab, BGB-A445 and LBL-007 in people with Non-small Cell Lung Cancer and Metastatic Non-small Cell Lung Cancer, run by BeiGene at 61 sites in 15 countries.
Trial summary
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Tislelizumab, BGB-A445 and LBL-007
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 61 sitesin 15 countries
- Study dates
- 10 Feb 2023to 29 Oct 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including nonsquamous or squamous subtypes, that is either locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
- No prior systemic therapy administered as the primary treatment for metastatic NSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, or adjuvant radiotherapy for locally advanced disease is permitted, provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months prior to randomization/enrollment.
- Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determined by a local or central laboratory using archival tumor tissue or a fresh biopsy. Participants with unknown PD-L1 expression are not eligible.
- At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Who cannot join
- Diagnosis of mixed small cell lung cancer.
- Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to:
- Epidermal growth factor receptor (EGFR) mutations
- Anaplastic lymphoma kinase (ALK) rearrangements
- B-Raf proto-oncogene (BRAF) mutations
- Rearranged during transfection (RET) fusions
Show all 18Show fewer
- c-ros oncogene 1 (ROS1) rearrangements
- Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded.
- Prior treatment with immune-based therapies that target immune checkpoint pathways, including:
- PD-1 (programmed cell death protein 1) inhibitors
- PD-L1 (programmed death-ligand 1) inhibitors
- PD-L2 (programmed death-ligand 2) inhibitors
- TIGIT (T cell immunoreceptor with Ig and ITIM domains) inhibitors
- LAG-3 (lymphocyte activation gene 3) inhibitors
- Participants previously treated with these agents in a neoadjuvant, adjuvant, or consolidation setting may be eligible if a treatment-free interval of at least 6 months has elapsed since the last dose and radiologic evidence of recurrence is present.
- Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment.
- Presence of active leptomeningeal disease, untreated or uncontrolled brain metastases, or active autoimmune disease.
- Note: Additional protocol-defined and sub-study-specific criteria may apply.
Trial locations and contacts
61 sites in 15 countries.
61 sites in 15 countries
China18 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
The Fifth Medical Center of Chinese Pla General Hospital
Beijing, Beijing Municipality, 100071
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Jining No1 Peoples Hospital East Branch
Jining, Shandong, 272002
Linyi Peoples Hospital
Linyi, Shandong, 276000
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000
Nantong Tumor Hospital Branch North
Nantong, Jiangsu, 226000
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, 200032
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, 200123
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013
Taizhou Hospital of Zhejiang
Taizhou, Zhejiang, 317000
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Henan Cancer Hospital
Zhengzhou, Henan, 450000
South Korea7 sites
Chungbuk National University Hospital
Cheongju-si, Chungcheongbukdo, 28644
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, 10408
The Catholic University of Korea, St Vincents Hospital
PaldalGu SuwonSi, Gyeonggi-do, 16247
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505
Australia6 sites
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148
Chris Obrien Lifehouse
Camperdown, New South Wales, NSW 2050
Northern Beaches Hospital
Frenchs Forest, New South Wales, NSW 2086
One Clinical Research
Nedlands, Western Australia, WA 6009
Port Macquarie Base Hospital
Port Macquarie, New South Wales, NSW 2444
St John of God Health Care
Subiaco, Western Australia, WA 6008
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
Valkyrie Clinical Trials
Los Angeles, California, 90067-2011
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, 10065-6800
Providence Portland Medical Center
Portland, Oregon, 97213-2933
Brazil5 sites
Hospital de Amor Barretos
Barretos, 14784-400
Hospital Do Cancer de Londrina
Londrina, 86015-520
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto
São José do Rio Preto, 15090-000
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira
São Paulo, 01246-000
Thailand4 sites
Songklanagarind Hospital (Prince of Songkhla University)
Hat Yai, 90110
Srinagarind Hospital (Khon Kaen University)
Muang, 40002
Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)
Muang, 50200
Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)
Ongkharak, 26120
Malaysia3 sites
Pulau Pinang Hospital
George Town, 10450
Tengku Ampuan Afzan Hospital
Kuantan, 25100
Sarawak General Hospital
Kuching, 93586
Spain3 sites
Hospital Universitario Vall Dhebron
Barcelona, 08035
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Virgen Del Rocio
Seville, 41013
France2 sites
Institut Curie
Paris, 75005
Chu Nantes Hopital Nord Laennec
SaintHerblain, 44805
Italy2 sites
Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs
Roma, 00144
Centro Ricerche Cliniche Di Verona
Verona, 37126
Romania2 sites
Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu
Bucureti, 022328
Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu
ClujNapoca, 400015
Moldova1 site
The Institute of Oncology, Arensia Exploratory Medicine
Chisinau, 2025
About this study
Official title: Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).
- Being tested
- Tislelizumab, BGB-A445, LBL-007, Carboplatin, Cisplatin
- Keywords
- Non-small Cell Lung Cancer, NSCLC, programmed cell death protein-1, PD-L1 Low Tumors, PD-L1 Negative Tumors, Metastatic Non-Small Cell Lung Cancer, PD-L1 High Tumors
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Administered by intravenous infusion
BGB-A445Drug
Administered by intravenous infusion
LBL-007Drug
Administered by intravenous infusion
CarboplatinDrug
Investigator's choice; administered by intravenous infusion
CisplatinDrug
Investigator's choice; administered by intravenous infusion
pemetrexedDrug
Investigator's choice; administered by intravenous infusion
PaclitaxelDrug
Investigator's choice; administered by intravenous infusion
Nab paclitaxelDrug
Investigator's choice; administered by intravenous infusion
BGB-15025Drug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Sub-study 1: Arm 1A | Experimental | Tislelizumab + BGB-A445 |
| Sub-study 1: Arm 2A | Experimental | Tislelizumab + LBL-007 Receives: Drug: Tislelizumab; Drug: LBL-007 |
| Sub-study 1: Arm 3A | Experimental | Tislelizumab + BGB-15025 Receives: Drug: Tislelizumab; Drug: BGB-15025 |
| Sub-study 1: Reference Arm Tislelizumab alone | Active comparator | Tislelizumab alone Receives: Drug: Tislelizumab |
| Sub-study 2: Arm 1B | Experimental | Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Receives: Drug: Tislelizumab; Drug: BGB-A445; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel |
| Sub-study 2: Arm 2B | Experimental | Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Receives: Drug: Tislelizumab; Drug: LBL-007; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel |
| Sub-study 2: Arm 3B | Experimental | Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Receives: Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: BGB-15025 |
| Sub-study 2: Reference Arm | Active comparator | Tislelizumab + investigator's choice of histology-appropriate chemotherapy Receives: Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirmed overall response rate (ORR)
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
Measured: Up to 6 months
Secondary outcomes (5)
Progression-free survival (PFS)
PFS is defined as the time from date of randomization, or the first dose for safety lead-in participants , until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.
Measured: Up to 1 year
Duration of Response (DOR)
DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever comes first as assessed by the investigator
Measured: Up to 1 year
Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with a best overall response of a complete response, partial response, or durable stable disease, as assessed by the investigator using RECIST v1.1
Measured: Up to 6 months
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a best overall response of complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1
Measured: Up to 6 months
Number of participants with adverse events (AEs)
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.
Measured: From the first dose of study drug(s) to 90 days after initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first, up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start10 Feb 2023
- Primary completion19 Dec 2025
- Study completion29 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635708
- Sponsor's protocol ID
- BGB-LC-201
- Other IDs
- CTR20230892, 2022-502738-18-00
- Status last verified
- Oct 2026
- First submitted
- 23 Nov 2022
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05635708
- Acronym / sponsor ID
- BGB-LC-201
- Keywords
- Non-small Cell Lung Cancer, NSCLC, programmed cell death protein-1, PD-L1 Low Tumors, PD-L1 Negative Tumors, Metastatic Non-Small Cell Lung Cancer, PD-L1 High Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 29 Oct 2026 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (< 50%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Sub-study 1: Arm 1A | Experimental | –Tislelizumab + BGB-A445 |
| Sub-study 1: Arm 2A | Experimental | Drug: Tislelizumab, Drug: LBL-007Tislelizumab + LBL-007 |
| Sub-study 1: Arm 3A | Experimental | Drug: Tislelizumab, Drug: BGB-15025Tislelizumab + BGB-15025 |
| Sub-study 1: Reference Arm Tislelizumab alone | Active comparator | Drug: TislelizumabTislelizumab alone |
| Sub-study 2: Arm 1B | Experimental | Drug: Tislelizumab, Drug: BGB-A445, Drug: Carboplatin, Drug: Cisplatin, Drug: pemetrexed, Drug: Paclitaxel, Drug: Nab paclitaxelTislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 |
| Sub-study 2: Arm 2B | Experimental | Drug: Tislelizumab, Drug: LBL-007, Drug: Carboplatin, Drug: Cisplatin, Drug: pemetrexed, Drug: Paclitaxel, Drug: Nab paclitaxelTislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 |
| Sub-study 2: Arm 3B | Experimental | Drug: Tislelizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: pemetrexed, Drug: Paclitaxel, Drug: Nab paclitaxel, Drug: BGB-15025Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 |
| Sub-study 2: Reference Arm | Active comparator | Drug: Tislelizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: pemetrexed, Drug: Paclitaxel, Drug: Nab paclitaxelTislelizumab + investigator's choice of histology-appropriate chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including nonsquamous or squamous subtypes, that is either locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.
- No prior systemic therapy administered as the primary treatment for metastatic NSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, or adjuvant radiotherapy for locally advanced disease is permitted, provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months prior to randomization/enrollment.
- Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determined by a local or central laboratory using archival tumor tissue or a fresh biopsy. Participants with unknown PD-L1 expression are not eligible.
- At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Key exclusion criteria (18 listed)
- Diagnosis of mixed small cell lung cancer.
- Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to:
- Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded.
- Prior treatment with immune-based therapies that target immune checkpoint pathways, including:
- Participants previously treated with these agents in a neoadjuvant, adjuvant, or consolidation setting may be eligible if a treatment-free interval of at least 6 months has elapsed since the last dose and radiologic evidence of recurrence is present.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TislelizumabAdministered by intravenous infusion | Drug | Sub-study 1: Arm 2A, Sub-study 1: Arm 3A, Sub-study 1: Reference Arm Tislelizumab alone, Sub-study 2: Arm 1B, Sub-study 2: Arm 2B, Sub-study 2: Arm 3B, Sub-study 2: Reference Arm |
| BGB-A445Administered by intravenous infusion | Drug | Sub-study 2: Arm 1B |
| LBL-007Administered by intravenous infusion | Drug | Sub-study 1: Arm 2A, Sub-study 2: Arm 2B |
| CarboplatinInvestigator's choice; administered by intravenous infusion | Drug | Sub-study 2: Arm 1B, Sub-study 2: Arm 2B, Sub-study 2: Arm 3B, Sub-study 2: Reference Arm |
| CisplatinInvestigator's choice; administered by intravenous infusion | Drug | Sub-study 2: Arm 1B, Sub-study 2: Arm 2B, Sub-study 2: Arm 3B, Sub-study 2: Reference Arm |
| pemetrexedInvestigator's choice; administered by intravenous infusion | Drug | Sub-study 2: Arm 1B, Sub-study 2: Arm 2B, Sub-study 2: Arm 3B, Sub-study 2: Reference Arm |
| PaclitaxelInvestigator's choice; administered by intravenous infusion | Drug | Sub-study 2: Arm 1B, Sub-study 2: Arm 2B, Sub-study 2: Arm 3B, Sub-study 2: Reference Arm |
| Nab paclitaxelInvestigator's choice; administered by intravenous infusion | Drug | Sub-study 2: Arm 1B, Sub-study 2: Arm 2B, Sub-study 2: Arm 3B, Sub-study 2: Reference Arm |
| BGB-15025Administered Orally | Drug | Sub-study 1: Arm 3A, Sub-study 2: Arm 3B |
Primary outcome
Confirmed overall response rate (ORR)
Time frame: Up to 6 months
ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 1 year
Duration of Response (DOR)
Time frame: Up to 1 year
Clinical Benefit Rate (CBR)
Time frame: Up to 6 months
Disease Control Rate (DCR)
Time frame: Up to 6 months
Number of participants with adverse events (AEs)
Time frame: From the first dose of study drug(s) to 90 days after initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first, up to approximately 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
61 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab, BGB-A445 and LBL-007 in people with Non-small Cell Lung Cancer and Metastatic Non-small Cell Lung Cancer, run by BeiGene at 61 sites in 15 countries.
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 5 inclusion and 18 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 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in China, South Korea, Australia, United States, Brazil and 10 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Confirmed overall response rate (ORR) (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Oct 2026.