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

NCT07288177 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: GCT1184-052025-522107-18-00jRCT2041250176CTR20260819
• Study Type: interventional
• Target: 240
• Locations: 3 countries
• Sites: 13

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)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator

  Approximately 3 years

Secondary Outcomes (8)

• Duration of Response (DOR) per RECIST v1.1 as Assessed by Investigator

  Approximately 4 years

• Disease Control Rate (DCR) per RECIST v1.1 as Assessed by Investigator

  Approximately 4 years

• Progression-free Survival (PFS)

  Approximately 4 years

• Overall Survival (OS)

  Approximately 4 years

• Maximum (Peak) Observed Serum Drug Concentration (Cmax) of Rina-S Related Analytes

  Approximately 12 months

Study Arms (1)

Rina-S

EXPERIMENTAL

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

Drug: Rina-S

Interventions

Rina-S DRUG

Intravenous (IV) infusion.

Also known as: Rinatabart Sesutecan, PRO1184, GEN1184

Rina-S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participant has NSCLC with histology other than adenocarcinoma
• 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.

Sponsors & Collaborators

• Genmab: lead

Study Sites (13)

Providence Medical Foundation (St. Joseph Heritage Healthcare)

Santa Rosa, California, 95403, United States

RECRUITING

Nebraska Hematology-Oncology

Lincoln, Nebraska, 68506, United States

RECRUITING

Astera Cancer Care

East Brunswick, New Jersey, 08816, United States

RECRUITING

ONE Onc: New York Oncology Hematology

Albany, New York, 12206, United States

RECRUITING

Tennessee Oncology - Nashville St. Thomas Midtown Clinic

Nashville, Tennessee, 37203, United States

RECRUITING

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

RECRUITING

Shanghai East Hospital

Shanghai, Pudong, China

RECRUITING

Kitasato University Hospital

Sagamihara, Kanagawa, Japan

RECRUITING

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, Japan

RECRUITING

Japan Community Health Care Organization Chukyo Hospital

Nagoya, Minami Ward, Japan

RECRUITING

Saitama Medical University International Medical Center

Saitama, Moroyama, Japan

RECRUITING

NHO Kinki Chuo Chest Medical Center

Sakai, Osaka, Japan

RECRUITING

Kyoto Prefectural University of Medicine

Kyoto, Japan

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Study Official

  Genmab

  STUDY DIRECTOR

Central Study Contacts

Genmab Trial Information

CONTACT

+4570202728; clinicaltrials@genmab.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Cohorts A and B will be randomized by dose. Randomization will not be used for Cohorts C, D, or E.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 17, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): November 22, 2027
• Study Completion (Estimated): November 22, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

JP (6); US (6); CN (1)