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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 : August 11, 2022
Sponsor:
Information provided by (Responsible Party):
BeiGene

Tracking Information
First Submitted Date  ICMJE August 16, 2021
First Posted Date  ICMJE August 20, 2021
Last Update Posted Date August 11, 2022
Actual Study Start Date  ICMJE November 16, 2021
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2021)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer
Official Title  ICMJE 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)
Brief Summary This is a randomized investigator and patient blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)
  • Nonsmall Cell Lung Cancer, Stage IV
Intervention  ICMJE
  • Drug: Ociperlimab
    Ociperlimab intravenous injection
    Other Name: BGB-A1217
  • Drug: Tislelizumab
    Tislelizumab intravenous injection
    Other Name: BGB-A317
  • Drug: histology-based chemotherapy
    Administered intravenously
  • Drug: Placebo
    Administered as an intravenous injection
Study Arms  ICMJE
  • Experimental: Arm A: Ociperlimab + tislelizumab histology-based chemotherapy
    Interventions:
    • Drug: Ociperlimab
    • Drug: Tislelizumab
    • Drug: histology-based chemotherapy
  • Placebo Comparator: Arm B: Placebo + tislelizumab + histology-based chemotherapy
    Interventions:
    • Drug: Tislelizumab
    • Drug: histology-based chemotherapy
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 26, 2022)
270
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2021)
200
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. At least one measurable lesion by the investigator per RECIST v1.1.

    .

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Key Exclusion Criteria:

  1. 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
  2. Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.
  3. Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.
  4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.
  5. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: BeiGene, USA, Inc 1-877-828-5568 ClinicalTrials@beigene.com
Listed Location Countries  ICMJE Australia,   Austria,   China,   France,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05014815
Other Study ID Numbers  ICMJE AdvanTIG-205
2021-001075-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party BeiGene
Original Responsible Party Same as current
Current Study Sponsor  ICMJE BeiGene
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account BeiGene
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP