Investigating a new treatment for advanced non-small cell lung cancer
A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects with Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1
This study is testing a new drug for adults with advanced lung cancer to see if it helps them feel better after other treatments haven't worked.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 43 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sutro Biopharma, Inc. Industry-sponsored |
| Drugs / interventions | luveltamab |
| Locations | 4 sites (Lake Mary, Florida and 3 other locations) |
| Trial ID | NCT06555263 on ClinicalTrials.gov |
What this trial studies
This Phase 2 study evaluates the efficacy and safety of luveltamab tazevibulin, an antibody drug conjugate targeting FOLR1, in adults with previously treated advanced or metastatic non-small cell lung cancer (NSCLC). Participants will receive the treatment intravenously every three weeks until disease progression or intolerable side effects occur. The study aims to determine how well this drug works in patients whose cancer expresses the FOLR1 protein. It is a multicenter, open-label trial involving multiple locations in Florida and Minnesota.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced or metastatic non-squamous NSCLC who have received 2 to 4 prior lines of systemic therapy.
Not a fit: Patients with untreated central nervous system metastases or those who have previously been treated with FOLR1-targeting therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer that expresses FOLR1.
How similar studies have performed: Other studies involving antibody drug conjugates have shown promise in treating various cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically or cytologically confirmed non-squamous/adenocarcinoma or adenosquamous NSCLC that is either unresectable Stage IIIb/c disease not amenable for definitive chemoradiation, or Stage IV. * Age ≥ 18 years * ECOG performance status 0 to 1. * Received at least 2 but no more than 4 prior lines of systemic therapy for advanced NSCLC * Disease progression during or following the most recent systemic anti-cancer therapy. * Positive FOLR1 expression per central testing * At least 1 measurable target lesion per RECIST 1.1 * Adequate organ function Exclusion Criteria: * Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor * Untreated central nervous system metastases * Ongoing immunosuppressive therapy, except for treated brain metastases, per criterion above. * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment * Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition * Previous solid organ transplantation * Concurrent participation in another therapeutic treatment trial
Where this trial is running
Lake Mary, Florida and 3 other locations
- Florida Cancer Specialists — Lake Mary, Florida, United States (Recruiting)
- Tampa General Hospital — Tampa, Florida, United States (Recruiting)
- HealthPartners Cancer Research Center — St. Paul, Minnesota, United States (Recruiting)
- Mary Crowley Cancer Research — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Jennifer Oliver, MD
- Email: lung@sutrobio.com
- Phone: 650-881-6579
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.