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Closed (no longer recruiting)Last updated: 2 February 2024

This phase III study is comparing the effectiveness of different immunotherapies (ociperlimab, tislelizumab and durvalumab), combined with concurrent chemoradiation therapy, in people with previously untreated, locally advanced non-small cell lung cancerPhase 3, Randomized, Open Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Plus Concurrent Chemoradiotherapy (cCRT) Followed by Ociperlimab Plus Tislelizumab or Tislelizumab Plus cCRT Followed by Tislelizumab Versus cCRT Followed by Durvalumab in Previously Untreated, Locally Advanced, Unresectable Non-Small Cell Lung Cancer

Clinical summary

Summary

Eligible participants will be randomly assigned to one of three arms. In Arm A (Experimental), participants will receive two cycles of ociperlimab (900mg intravenously [IV]) combined with tislelizumab (200mg IV) every 3 weeks (Q3W) with Concurrent Chemoradiotherapy (cCRT), followed by further treatment with ociperlimab (900mg IV) combined with tislelizumab (200mg IV) Q3W up to 1 year after the cCRT phase. In Arm B (Active Comparator), participants will receive tislelizumab (200mg IV Q3W) combined with cCRT, followed by further treatment with tislelizumab (200mg IV Q3W) up to 1 year after the cCRT phase. In Arm C, (Experimental), participants will receive two cycles of cCRT followed by treatment with durvalumab (10mg/kg IV) once every 2 weeks (Q2W) up to 1 year after the cCRT phase.

Conditions

This trial is treating patients with non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

III

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

Phase 3, Randomized, Open Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Plus Concurrent Chemoradiotherapy (cCRT) Followed by Ociperlimab Plus Tislelizumab or Tislelizumab Plus cCRT Followed by Tislelizumab Versus cCRT Followed by Durvalumab in Previously Untreated, Locally Advanced, Unresectable Non-Small Cell Lung Cancer

Eligibility

Inclusion

  1. Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
  2. Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017, derived from IASLC) prior to initiation of cCRT.
  3. Participant must have completed at least 2 cycles of platinum-based chemotherapy concurrent with radiotherapy
  4. Participants must have not experienced PD following definitive, platinum-based cCRT.
  5. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
  6. Participants must have adequate organ function
  7. Agree to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or approximately 6 to 15 freshly cut unstained slides) or fresh biopsy obtained prior to cCRT (if archival tissue is not available) for prospective central evaluation of PD-L1 levels and retrospective analysis of other biomarkers.

Exclusion

  1. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
  2. Diagnosed with NSCLC that harbors an epidermal growth factor receptor (EGFR) sensitizing mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene translocation or RET gene rearrangement.
  3. Participants who received systemic anticancer treatment besides the specified cCRT.
  4. Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT.
  5. Active autoimmune diseases or history of autoimmune diseases that may relapse.
  6. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone [in Japan, prednisolone] or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment.
  7. Infection (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment.

Note: Antiviral therapy is permitted for participants with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

NOTE: Other protocol Inclusion/Exclusion criteria may apply.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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