Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT05014815 |
Recruitment Status :
Recruiting
First Posted : August 20, 2021
Last Update Posted : May 5, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: Ociperlimab Drug: Tislelizumab Drug: histology-based chemotherapy Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2, Randomized, Double-blind Study of Ociperlimab (BGB A1217) and Tislelizumab With Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Without Sensitizing EGFR or ALK Mutations Who Have Received No Previous Treatment for Metastatic Disease |
Actual Study Start Date : | November 16, 2021 |
Estimated Primary Completion Date : | April 2023 |
Estimated Study Completion Date : | April 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy |
Drug: Ociperlimab
Ociperlimab intravenous injection
Other Name: BGB-A1217 Drug: Tislelizumab Tislelizumab intravenous injection
Other Name: BGB-A317 Drug: histology-based chemotherapy Administered intravenously |
Placebo Comparator: Arm B: Placebo + tislelizumab + histology-based chemotherapy |
Drug: Tislelizumab
Tislelizumab intravenous injection
Other Name: BGB-A317 Drug: histology-based chemotherapy Administered intravenously Drug: Placebo Administered as an intravenous injection |
- Progression-free Survival (PFS) as Assessed by Investigators [ Time Frame: Up to approximately 30 months ]PFS will be defined as the time from the date of randomization to the date of the first objectively documented tumor progression per RECIST v1.1, or death, whichever occurs first
- Overall Response Rate (ORR) as Assessed by Investigators [ Time Frame: Up to approximately 30 months ]ORR will be defined as the proportion of participants with a documented, confirmed complete response or partial response per RECIST v1.1.
- Overall Survival (OS) [ Time Frame: Up to approximately 30 months ]OS will be defined as the time from the date of randomization to the date of death due to any cause.
- Number of Participants Experiencing Adverse Events (AEs) [ Time Frame: 90 days (±14) after last dose ]The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).
- Serum concentrations of ociperlimab and tislelizumab at prespecified timepoints [ Time Frame: Up to approximately 12 months or end of treatment visit ]
- Immunogenic responses to ociperlimab and tislelizumab, evaluated through detection of anti-drug antibodies (ADAs). [ Time Frame: Up to approximately 12 months or end of treatment visit ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Histologically confirmed metastatic (Stage IV) squamous or non-squamous NSCLC.
- Treatment-naive for metastatic squamous or non-squamous NSCLC.
- Agreement to provide archival tissue or fresh biopsy for the prospectively determination of PD-L1 levels and retrospective analysis of other biomarkers.
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At least 1 measurable lesion as defined per RECIST v1.1.
.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Key Exclusion Criteria:
- Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.
- Prior therapy with an anti-programmed cell death protein (PD-1), anti-PD-L1, anti-programmed cell death ligand-2 (PD-L2), anti-TIGIT, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Any active malignancy ≤ 2 years before randomization except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively (for example, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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): NCT05014815
Contact: BeiGene | 1-877-828-5568 | ClinicalTrials@beigene.com |

Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT05014815 |
Other Study ID Numbers: |
AdvanTIG-205 2021-001075-17 ( EudraCT Number ) |
First Posted: | August 20, 2021 Key Record Dates |
Last Update Posted: | May 5, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
metastatic Lung Cancer Non-Squamous Ociperlimab Tislelizumab |
Anti-PD-1 BGB-A317 BGB-A1217 Anti-TIGIT |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |