Locally Advanced, Unresectable, or Metastatic Non -Small Cell Lung Cancer
Conditions
Interventions
1) Safety run in study:
Tislelizumab 200 mg intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks on (Day 1 of each 21-day cycle)
2)Main study:
Tislelizumab 200 mg intravenou
Sponsors
Nakamura Haruki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Safety Run In 1.Histologically or cytologically documented locally advanced or metastatic solid tumor for which standard of care treatment in Japan is not available or not tolerated 2.ECOG Performance Status = 120 days after the last dose of study drug, and must have a negative urine or serum pregnancy test = 120 days after the last dose of study drug. Main Study 1.Histologically or cytologically documented locally advanced or recurrent NSCLC that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic nonsquamous or squamous NSCLC. 2.No prior systemic treatment for metastatic NSCLC. 3.Agreement to provide archival tissue or fresh biopsy for prospective central evaluation of PD-L1 levels and retrospective analysis of other biomarkers 4.Tumors with PD-L1 TC >= 50% expression as centrally determined (or locally in the US and Japan). 5.At least 1 measurable lesion as defined per RECIST v1.1. 6.ECOG Performance Status = 120 days after the last dose of study drug, and must have a negative urine or serum pregnancy test = 120 days after the last dose of study drug.
Exclusion criteria
Exclusion criteria: Safety run-in part 1. Eligible to receive a standard of care therapy in Japan 2. Has received more than 2 prior systemic therapies for metastatic solid tumors 3. Discontinued prior therapy with an anti-PD-1, anti-PD-L1, anti-programmed cell death ligand-2 (PD-L2), anti-T-cell immunoglobulin and ITIM domain (TIGIT), or any otherantibody or drug specifically targeting T-cell co-stimulation or checkpoint pathway due to serious or => Grade 3 (per NCI-CTCAE v5.0 criteria) immune-related toxicity. 4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 5. Active autoimmune diseases or history of autoimmune diseases that may relapse. 6. Any active malignancy 10 mg daily of prednisone or equivalent) or other immunosuppressive medication Grade 1 laboratory test abnormalities in potassium, sodium, or corrected calcium despite standard medical management or => Grade 3 hypoalbuminemia 500 IU/mL (or > 2500 copies/mL) at Screening 12. Patients with active hepatitis C. 13. Known history of HIV infection 14. Any major surgical procedure Grade 2 in severity <= 6 months before C1D1. f. Any history of cerebrovascular accident <= 6 months before C1D1. g. Uncontrolled hypertension that cannot be managed by standard antihypertension medications <= 28 days before C1D1. h. Any episode of syncope or seizure <= 28 days before C1D1. 17. A history of severe hypersensitivity reactions to other monoclonal antibodies. 18. Was administered a live vaccine <= 28 days before C1D1 19. Toxicities from prior therapy that have not recovered to baseline, <= Grade 1, or stabilized, except for AEs not considered a likely safety risk 20. Underlying medical conditions (including laboratory abnormalities) or alcohol or drug abuse or dependence that will be unfavorable for the administration of study drug or that will affect the explanation of drug toxicity or AEs, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Safety run in study: To investigate the safety and tolerability of ociperlimab in combination with tislelizumab in Japanese patients. To characterize the pharmacokinetics (PK) of ociperlimab in combination with tislelizumab in Japanese patients. 2)Main study: OS (time from the date of randomization to the date of death due to any cause) | — |
Countries
China, France, Italy, Japan, Korea, Poland, Rumania, Russia, Spain, Taiwan, Turkey, UK, US
Contacts
Public ContactHaruki Nakamura
IQVIA Services Japan G.K.
Outcome results
None listed