AzTrials
AzTrials

Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)Phase 2NCT05014815

Ociperlimab With Tislelizumab and Chemotherapy in Participants With Untreated Metastatic Non-Small Cell Lung Cancer

A Phase 2 study testing Ociperlimab, Tislelizumab and Carboplatin in people with Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) and Nonsmall Cell Lung Cancer, Stage IIIB, run by BeiGene at 64 sites in 8 countries.

Completed

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

Official record
Search all trials

Trial summary

This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ociperlimab, Tislelizumab and Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
64 sitesin 8 countries
Study dates
16 Nov 2021to 4 Sep 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 histologically or cytologically confirmed locally advanced or recurrent non-small cell lung cancer (NSCLC) that was not eligible for curative surgical resection and/or definitive radiotherapy, with or without chemotherapy. Alternatively, participants had metastatic non-squamous or squamous NSCLC.
  • Participants had not received any prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapies. Those who had previously received neoadjuvant or adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease, were required to have experienced a disease-free interval of at least 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
  • Archival tumor tissue or a fresh biopsy (if archival tissue was unavailable) was required for programmed death-ligand 1 (PD-L1) level assessment and retrospective biomarker analyses. Only participants with evaluable PD-L1 results were considered eligible.
  • Participants were required to have had at least one measurable lesion as assessed by the investigator in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
  • Participants had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Who cannot join

  • Participants were excluded if they had known mutations in any of the following genes:
  • Epidermal Growth Factor Receptor (EGFR): For participants with non-squamous NSCLC and unknown EGFR mutation status, tissue-based EGFR testing (performed either locally or at a central laboratory) or an endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test was required prior to enrollment. Those found to harbor EGFR-sensitizing mutations were excluded.
  • Anaplastic Lymphoma Kinase (ALK) fusion oncogene.
  • B-Raf Proto-Oncogene (BRAF) V600E mutation.
  • ROS Proto-Oncogene 1 (ROS1) rearrangement.
  • Participants who had received prior treatment with EGFR inhibitors, ALK inhibitors, or other targeted therapies for known driver mutations.
Show all 10Show fewer
  • Participants who had received any prior therapies targeting T-cell costimulatory or checkpoint pathways (e.g., programmed cell death protein 1 [PD-1], programmed death-ligand 1 [PD-L1], or cytotoxic T-lymphocyte-associated protein 4 [CTLA-4]) for metastatic NSCLC were excluded.
  • Participants who had any condition requiring systemic treatment with corticosteroids at a dose greater than 10 mg of prednisone (or equivalent) daily, or other immunosuppressive medications within 14 days prior to randomization.
  • Participants who had an active infection, including but not limited to tuberculosis, requiring systemic antibacterial, antifungal, or antiviral treatment within 14 days prior to randomization were excluded.
  • Note: Additional protocol-defined inclusion and exclusion criteria may have applied.

Trial locations and contacts

64 sites in 8 countries.

64 sites in 8 countries

China24 sites

  • Ansteel Group General Hospital

    Anshan, Liaoning, 114000

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Changzhou Cancer Hospital

    Changzhou, Jiangsu, 213001

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The First Peoples Hospital of Chenzhou

    Chenzhou, Hunan, 423000

  • Xinqiao Hospital Affiliated to the Army Medical University

    Chongqing, Chongqing Municipality, 400037

  • Daping Hospital, Third Military Medical University

    Chongqing, Chongqing Municipality, 400042

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong, 510030

  • Zhejiang Provincial Peoples Hospital

    Hangzhou, Zhejiang, 310014

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Huzhou Central Hospital

    Huzhou, Zhejiang, 313003

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jingzhou Central Hospital

    Jingzhou, Hubei, 434020

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

  • The First Peoples Hospital of Kashgar

    Kashgar, Xinjiang, 844099

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, 730000

  • Liaocheng Peoples Hospital

    Liaocheng, Shandong, 252000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Huashan Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200433

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

United States11 sites

  • Texas Oncology Tyler Longview

    Austin, Texas, 78705-1163

  • Xcancerdayton Physician Network

    Dayton, Ohio, 45409-1328

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242-1009

  • Tennessee Cancer Specialist

    Knoxville, Tennessee, 37909-1327

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada, 89169-3321

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067-2011

  • Rj Zuckerberg Cancer Center

    New Hyde Park, New York, 11042-1118

  • North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists (New York)

    New York, New York, 10028-0517

  • North Shore Hematology Oncology Associates Dba New York Cancer and Blood Specialists

    Port Jefferson Station, New York, 11776-8066

  • Cancer Care Northwest

    Spokane Valley, Washington, 99216-1020

  • Ny Cancer and Blood Specialists

    The Bronx, New York, 10469-5930

Other trials in United States

South Korea10 sites

  • Cha Bundang Medical Center, Cha University

    BundangGu SeongnamSi, Gyeonggi-do, 13496

  • Ulsan University Hospital

    Donggu, Ulsan Gwang'yeogsi, 44033

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

  • Korea University Guro Hospital

    GuroGu, Seoul Teugbyeolsi, 08308

  • Kangbuk Samsung Hospital

    JongnoGu, Seoul Teugbyeolsi, 03181

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

  • Dong A University Hospital

    Seogu, Busan Gwang'yeogsi, 49201

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, Seoul Teugbyeolsi, 06273

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Australia8 sites

  • Townsville University Hospital

    Douglas, Queensland, 4814

  • Border Medical Oncology

    East Albury, New South Wales, 2640

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales, 2086

  • Olivia Newton John Cancer Wellness and Research Centre

    Heidelberg, Victoria, 3084

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, 2444

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350

Other trials in Australia

Spain5 sites

  • Centro Oncologico de Galicia

    A Coruña, 15009

  • Ch Provincial de Castellon

    Castellon, 50009

  • Complejo Asistencial Universitario de Leon

    León, 24071

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Fundacion Instituto Valenciano de Oncologia Ivo

    Valencia, 46009

Other trials in Spain

France4 sites

  • Centre Hospitalier Regional Universitaire de Caen

    Caen, 14000

  • Institut Curie

    Paris, 75005

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Hopital Charles Nicolle Clinique Pneumologique

    Rouen, 76000

Other trials in France

Austria1 site

  • Klinik Penzing Wien, Abteilung Fur Atemwegs

    Vienna, 1140

Other trials in Austria

Greece1 site

  • St Lukes Hospital

    Thessaloniki, 55236

Other trials in Greece

About this study

Official title: AdvanTIG-205: A Phase 2, Randomized Study of Ociperlimab (BGB-A1217) and Tislelizumab With Chemotherapy in Patients With Previously Untreated Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer (NSCLC)

This study aimed to evaluate the safety and effectiveness of ociperlimab combined with tislelizumab and chemotherapy, compared to tislelizumab and chemotherapy alone, in participants with non-small cell lung cancer (NSCLC) that was locally advanced, could not be removed by surgery, or had spread to other parts of the body.

Keywords
metastatic, Lung Cancer, Non-Squamous, Ociperlimab, Tislelizumab, Anti-PD-1, BGB-A317, BGB-A1217, Anti-TIGIT
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms

What participants receive

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

  • OciperlimabDrug

    Also called BGB-A1217

    900 mg intravenously (IV) once every 3 weeks (Q3W)

  • TislelizumabDrug

    Also called BGB-A317

    200 mg IV Q3W

  • CarboplatinDrug

    Area under the concentration-time curve (AUC) of 5 or 6, administered on Day 1 of each 21-day cycle

  • PaclitaxelDrug

    75 or 200 mg per square meter (mg/m²) of body surface area, administered on Day 1 of each 21-day cycle

  • Nab paclitaxelDrug

    100 mg/m², administered intravenously on Days 1, 8, and 15 of each 21-day cycle

  • CisplatinDrug

    75 mg/m², administered intravenously on Day 1 of each 21-day cycle

  • PemetrexedDrug

    500 mg/m² administered intravenously on Day 1 of each 21-day cycle

  • PlaceboDrug

    Administered intravenously Q3W to match ociperlimab

Study groups in NCT05014815
Study groupRoleWhat they receive
Arm A (O+T+C)ExperimentalDuring the induction phase, participants received ociperlimab (O) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (on Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received O 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received O 900 mg IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.
Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Cisplatin; Drug: Pemetrexed
Arm B (P+T+C)Placebo comparatorDuring the induction phase, participants received placebo (P) 900 mg IV, tislelizumab (T) 200 mg IV, and histology-based chemotherapy (C) every 21 days for 4-6 cycles. For squamous NSCLC, chemotherapy included carboplatin AUC 5 or 6 (Day 1) + paclitaxel 175 or 200 mg/m² (Day 1) or nab-paclitaxel 100 mg/m² (Days 1, 8, 15) every 3 weeks. For non-squamous NSCLC, chemotherapy included cisplatin 75 mg/m² or carboplatin AUC 5 (Day 1) + pemetrexed (P) 500 mg/m² IV (Day 1), every 3 weeks. In the maintenance phase, non-squamous NSCLC participants received placebo 900 mg IV, T 200 mg IV, and pemetrexed 500 mg/m² IV every 3 weeks. Squamous NSCLC participants received placebo IV and T 200 mg IV every 3 weeks until toxicity, consent withdrawal, or investigator-determined lack of benefit.
Receives: Drug: Tislelizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Cisplatin; Drug: Pemetrexed; Drug: Placebo

What is being measured

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

  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 randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

Secondary outcomes (4)

  1. Objective Response Rate (ORR)

    Objective 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 randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 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 randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

  3. 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 clinical cutoff date. Median OS was calculated using the Kaplan-Meier method. Data for participants who were alive at the clinical 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 randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months

  4. Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    The number of participants who experienced TEAEs and SAEs was reported. 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 linked to the study drug. Investigators evaluated the severity of each adverse event according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.

    Measured: From first dose of study drug to 30 days after last dose, up to the study completion date cut-off date of 04 September 2024 (up to 32.4 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 start16 Nov 2021
  3. Primary completion4 Sep 2024
  4. Study completion4 Sep 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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05014815
Sponsor's protocol ID
AdvanTIG-205
Other IDs
2021-001075-17, CTR20212782
Status last verified
Aug 2025
First submitted
16 Aug 2021
Last updated
16 Sep 2025
Data monitoring committee
Yes
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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ociperlimab, Tislelizumab and Carboplatin in people with Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) and Nonsmall Cell Lung Cancer, Stage IIIB, run by BeiGene at 64 sites in 8 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 10 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in China, United States, South Korea, Australia, Spain and 3 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. Some participants in this study may receive a placebo. 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 16 Sep 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?

Progression-free Survival (PFS) (time frame: From randomization up to the final efficacy analysis data cut-off date of 04 September 2024; Up to 33 months). 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 NCT05014815.

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 16 Sep 2025.

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