Rina-S treatment for advanced non-small cell lung cancer
A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer
This Phase 2 trial will test whether Rina-S by itself can shrink or control advanced non-small cell lung cancer in people whose cancer has progressed after prior treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Genmab Industry-sponsored |
| Locations | 15 sites (Fountain Valley, California and 14 other locations) |
| Trial ID | NCT07288177 on ClinicalTrials.gov |
What this trial studies
This is an open-label, multicenter Phase 2 trial giving Rina-S as a single agent to about 240 participants with locally advanced or metastatic NSCLC of adenocarcinoma histology. Participants will receive repeated 3-week treatment cycles, with an average treatment duration of about 12 months and 1–5 clinic visits per cycle for safety monitoring, imaging, and blood tests. The trial includes multiple cohorts for participants with or without select genomic alterations and will collect safety, efficacy, pharmacokinetics, and pharmacodynamics data. All enrolled participants receive active drug and must have measurable disease and ECOG performance status 0–1 at enrollment.
Who should consider this trial
Good fit: Ideal candidates are people with histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, measurable disease by RECIST v1.1, disease progression after the most recent regimen, and an ECOG performance status of 0 or 1.
Not a fit: Patients with non-adenocarcinoma NSCLC histology, poor performance status (ECOG >1), active uncontrolled second malignancies, or who cannot attend study site visits are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, Rina-S could provide a new treatment option that shrinks tumors or slows disease progression in some patients with advanced NSCLC.
How similar studies have performed: Targeted single-agent therapies have succeeded in subsets of NSCLC defined by specific genomic alterations, but Rina-S itself is a novel agent and its clinical benefit has not yet been established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Fountain Valley, California and 14 other locations
- Compassionate Cancer Care Center — Fountain Valley, California, United States (Recruiting)
- 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)
- Montefiore Medical Park — The Bronx, 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)
- Kyoto Prefectural University of Medicine — Kyoto, Kyoto, 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)
Study contacts
- Study coordinator: Genmab Trial Information
- Email: clinicaltrials@genmab.com
- Phone: +4570202728
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.