--- title: Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer nct_id: NCT07288177 overall_status: RECRUITING phase: PHASE2 sponsor: Genmab study_type: INTERVENTIONAL primary_condition: Non-small Cell Lung Cancer (NSCLC) countries: United States, China, Japan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07288177.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07288177" ct_last_update_post_date: 2026-05-05 last_seen_at: "2026-05-12T07:14:21.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer **Official Title:** A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer **NCT ID:** [NCT07288177](https://clinicaltrials.gov/study/NCT07288177) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 240 - **Lead Sponsor:** Genmab - **Conditions:** Non-small Cell Lung Cancer (NSCLC) - **Start Date:** 2026-01-30 - **Completion Date:** 2028-11-22 - **CT.gov Last Update:** 2026-05-05 ## 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. ## Detailed Description 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Rina-S** (EXPERIMENTAL) — Multiple cohorts (Cohorts A, B, C, D, and E) will receive Rina-S as monotherapy. ## Interventions - **Rina-S** (DRUG) — Intravenous (IV) infusion. ## Primary Outcomes - **Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Investigator** _(time frame: Approximately 3 years)_ ## Secondary Outcomes - **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)_ ## Locations (13) - Providence Medical Foundation (St. Joseph Heritage Healthcare), Santa Rosa, California, United States — _RECRUITING_ - Nebraska Hematology-Oncology, Lincoln, Nebraska, United States — _RECRUITING_ - Astera Cancer Care, East Brunswick, New Jersey, United States — _RECRUITING_ - ONE Onc: New York Oncology Hematology, Albany, New York, United States — _RECRUITING_ - Tennessee Oncology - Nashville St. Thomas Midtown Clinic, Nashville, Tennessee, United States — _RECRUITING_ - Virginia Cancer Specialists, Fairfax, Virginia, 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_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.providence medical foundation (st. joseph heritage healthcare)|santa rosa|california|united states` — added _(2026-05-12)_ - `locations.nebraska hematology-oncology|lincoln|nebraska|united states` — added _(2026-05-12)_ - `locations.astera cancer care|east brunswick|new jersey|united states` — added _(2026-05-12)_ - `locations.one onc: new york oncology hematology|albany|new york|united states` — added _(2026-05-12)_ - `locations.tennessee oncology - nashville st. thomas midtown clinic|nashville|tennessee|united states` — added _(2026-05-12)_ - `locations.virginia cancer specialists|fairfax|virginia|united states` — added _(2026-05-12)_ - `locations.shanghai east hospital|shanghai|pudong|china` — added _(2026-05-12)_ - `locations.kitasato university hospital|sagamihara|kanagawa|japan` — added _(2026-05-12)_ - `locations.kanagawa cardiovascular and respiratory center|yokohama|kanagawa|japan` — added _(2026-05-12)_ - `locations.japan community health care organization chukyo hospital|nagoya|minami ward|japan` — added _(2026-05-12)_ - `locations.saitama medical university international medical center|saitama|moroyama|japan` — added _(2026-05-12)_ - `locations.nho kinki chuo chest medical center|sakai|osaka|japan` — added _(2026-05-12)_ - `locations.kyoto prefectural university of medicine|kyoto||japan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07288177.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07288177* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*