Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer

Part of paid clinical trials in Fountain Valley, California.

Sponsor
Genmab
Study ID
NCT07288177
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rina-S — DRUG
    Intravenous (IV) infusion.

Study Details

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.

Key Dates

Start date
Jan 30, 2026
Status verified
Jun 2026
Primary completion
Nov 22, 2027
Completion
Nov 22, 2028

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rina-S
    Multiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy.

Primary Outcome Measure

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator [ Time Frame: Approximately 3 years ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Compassionate Cancer Care CenterFountain ValleyCalifornia92708-
Providence Medical Foundation (St. Joseph Heritage Healthcare)Santa RosaCalifornia95403-
Nebraska Hematology-OncologyLincolnNebraska68506-
Astera Cancer CareEast BrunswickNew Jersey08816-
ONE Onc: New York Oncology HematologyAlbanyNew York12206-
Montefiore Medical ParkThe BronxNew York10461-
Tennessee Oncology - Nashville St. Thomas Midtown ClinicNashvilleTennessee37203-
Virginia Cancer SpecialistsFairfaxVirginia22031-

Find similar trials in Fountain Valley, CA

By research site
Compassionate Cancer Care Center· Fountain Valley, CAProvidence Medical Foundation (St. Joseph Heritage Healthcare)· Santa Rosa, CANebraska Hematology-Oncology· Lincoln, NEAstera Cancer Care· East Brunswick, NJONE Onc: New York Oncology Hematology· Albany, NYMontefiore Medical Park· The Bronx, NY

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