This Phase 2 study will be conducted in different countries around the world with up to about 240 participants. The purpose of this study is to evaluate how well Rina-S works against lung cancer. The treatment in this study is Rina-S monotherapy (by itself). All participants will receive active drug; no one will be given placebo. The treatment duration will be different for every participant, but an average of 12 months is expected. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.
This is a Phase 2, open-label, multicenter, multi-cohort trial to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics of Rina-S as monotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), with or without select genomic aberrations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Intravenous (IV) infusion.
Compassionate Cancer Care Center
Fountain Valley, California, United States
RECRUITINGKaiser Permanente San Diego Mission Road
San Diego, California, United States
RECRUITINGProvidence Medical Foundation (St. Joseph Heritage Healthcare)
Santa Rosa, California, United States
RECRUITINGMedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator
Time frame: Approximately 3 years
Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator
Time frame: Approximately 4 years
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator
Time frame: Approximately 4 years
Progression-free Survival (PFS)
Time frame: Approximately 4 years
Overall Survival (OS)
Time frame: Approximately 4 years
Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes
Time frame: Approximately 12 months
Time to Reach Maximum (Peak) Serum Drug Concentration (Tmax) of Rina-S Related Analytes
Time frame: Approximately 12 months
Number of Participants with Antidrug Antibodies (ADAs)
Time frame: Approximately 12 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Approximately 4 years
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Moffitt Cancer Center and Research Institute
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RECRUITING...and 64 more locations