Recruiting
Phase 2

Rina-S

Sponsor:

Genmab

Code:

NCT07288177

Conditions

Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Rina-S

Study Details

Brief summary:

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study ID

NCT07288177

Start date

Jan 30, 2026

Status verified date

Aug, 2026

Completion date

Nov 22, 2028

Anticipated

Primary completion date

Nov 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
  • Participant must have radiological disease progression while on or after receiving the most recent regimen.
  • Participants either may have actionable genetic alterations (AGAs) or no AGAs.
  • Participant has measurable disease according to RECIST v1.1.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.

Key Exclusion Criteria (all study cohorts):

  • Participant has NSCLC with histology other than adenocarcinoma
  • Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
  • Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Study Design

Enrollment

240 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Rina-S

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

Interventions

Rina-S

Intravenous (IV) infusion.

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 and Locations

Central contacts

Genmab Trial Information

+4570202728clinicaltrials@genmab.com

Locations

Compassionate Cancer Care Center

Recruiting

Fountain Valley, California, United States, 92708

Kaiser Permanente San Diego Mission Road

Recruiting

San Diego, California, United States, 92108

Providence Medical Foundation (St. Joseph Heritage Healthcare)

Recruiting

Santa Rosa, California, United States, 95403

MedStar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Moffitt Cancer Center and Research Institute

Recruiting

Tampa, Florida, United States, 33612

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

St. Vincent Frontier Cancer Center

Recruiting

Billings, Montana, United States, 59102

Nebraska Hematology-Oncology

Recruiting

Lincoln, Nebraska, United States, 68506

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

ONE Onc: New York Oncology Hematology

Recruiting

Albany, New York, United States, 12206

Montefiore Medical Park

Recruiting

The Bronx, New York, United States, 10461

UNC Health - University of North Carolina

Recruiting

Chapel Hill, North Carolina, United States, 27514

Williamette Valley Cancer Institute and Research Center

Recruiting

Eugene, Oregon, United States, 97401

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213

Providence Oncology & Hematology Care Clinic - Westside

Recruiting

West Haven-Sylvan, Oregon, United States, 97225

Tennessee Oncology - Nashville St. Thomas Midtown Clinic

Recruiting

Nashville, Tennessee, United States, 37203

Tennessee Oncology Nashville - SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

More Information

Sponsor

Genmab

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Genmab on 2026-08-26.