Study with Various Immunotherapy Treatments in Participants With Lung Cancer
- Conditions
- Advanced Non-Small Cell Lung CancerTherapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502916-35-01
- Lead Sponsor
- Arcus Biosciences Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 263
Histologically confirmed, documented diagnosis of Stage IV metastatic, NSCLC, Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1, At least one measurable target lesion per RECIST v1.1, Adequate organ and bone marrow function, Participants must be willing to provide adequate tumor tissue
Underlying medical conditions that, in the Investigator's or Sponsor's opinion, will make the administration of Investigational Product(s) (IPs) hazardous, Use of any live vaccines against infectious diseases within 28 days of first dose of IP(s), Concurrent chronic medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications (absorbable topical corticosteroids are not excluded), Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the objective response rate (ORR) of immunotherapy-based combination therapy and to assess the safety and tolerability of immunotherapy-based combination therapy;Secondary Objective: To assess the clinical activity of the immunotherapy-based combination therapy, based on investigator assessment according to RECIST v1.1, where applicable, To describe the pharmacokinetic (PK) profile of investigation study treatments, To describe the immunogenicity of investigational biologic study treatments;Primary end point(s): Objective response rate (ORR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), The incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Overall Survival (OS);Secondary end point(s):Progression-free Survival (PFS) as determined by the Investigator according to RECIST v1.1;Secondary end point(s):Disease Control Rate (DCR);Secondary end point(s):Duration of response (DoR) as determined by the Investigator according to RECIST v1.1;Secondary end point(s):Investigational study treatments peak plasma or serum concentration (Cmax);Secondary end point(s):Investigational study treatments time of peak concentration (Tmax);Secondary end point(s):Investigational study treatments area under the plasma or serum concentration versus time curve (AUC);Secondary end point(s):Percentage of biologic treatment-emergent antidrug-antibody (ADA)-positive participants and ADA-negative participants