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

NCT07288177 · Genmab
In plain English

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Official title
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
About this study
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.
Eligibility criteria
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 target: 240 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-30
Estimated completion: 2028-11-22
Last updated: 2026-04-08
Interventions
Drug: Rina-S
Primary outcomes
  • Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator (Approximately 3 years)
Sponsor
Genmab · industry
Contacts & investigators
ContactGenmab Trial Information · contact · clinicaltrials@genmab.com · +4570202728
InvestigatorStudy Official · study_director, Genmab
All locations (8)
Providence Medical Foundation (St. Joseph Heritage Healthcare)Recruiting
Santa Rosa, California, United States
Nebraska Hematology-OncologyRecruiting
Lincoln, Nebraska, United States
Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
ONE Onc: New York Oncology HematologyRecruiting
Albany, New York, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Kyoto Prefectural University of MedicineRecruiting
Kyoto, Kyoto, Japan
Japan Community Health Care Organization Chukyo HospitalRecruiting
Nagoya, Minami Ward, Japan
NHO Kinki Chuo Chest Medical CenterRecruiting
Sakai, Osaka, Japan
Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer · TrialPath