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 : January 4, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC) Nonsmall Cell Lung Cancer, Stage IV | Drug: Ociperlimab Drug: Tislelizumab Drug: histology-based chemotherapy Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 270 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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) |
Actual Study Start Date : | November 16, 2021 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | November 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.
- Duration of Response (DoR) As Assessed by Investigators [ Time Frame: Up to approximately 30 months ]DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first
- 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 or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.
- No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Patients who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.
- Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only patients who have evaluable PD-L1 results are eligible.
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At least one measurable lesion by the investigator per RECIST v1.1.
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- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
Key Exclusion Criteria:
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Known mutations in:
- EGFR gene Note: For non-squamous NSCLC, patients with unknown EGFR mutation status will be required to have a tissue-based EGFR test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test locally. Patients found to have EGFR-sensitizing mutations will be excluded.
- ALK fusion oncogene.
- BRAF V600E
- ROS1
- Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
- Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
- Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization.
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, USA, Inc | 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: | January 4, 2023 |
Last Verified: | January 2023 |
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 Tislelizumab Antineoplastic Agents, Immunological Antineoplastic Agents |