Clinical trial · Interventional
Study to Investigate Luveltamab Tazevibulin in Adults With Advanced or Metastatic 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
NCT06555263CI-TRIAL-00094011withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated Early
Summary
Brief summary (as posted)
A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer Metastatic | — | UNRESOLVED | — |
| Lung Cancer, Non-small Cell | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Lung Cancer, Nonsmall Cell | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Cancer Non-Small Cell Stage IIIB | — | UNRESOLVED | — |
| Lung Cancer Non-small Cell Stage IV | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Luveltamab tazevibulin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Luveltamab tazevibulin
- description
- 4.3 mg/kg q3w Eligible subjects with stable disease (SD) may escalate to 5.2 mg/kg q3w after Cycle 4, with Sponsor approval.
- interventionNames
- Drug: Luveltamab tazevibulin
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 24 months
- description
- Best response of complete response (CR) or partial response (PR) per RECIST 1.1
Secondary outcomes (6)
- measure
- Duration of Response (DOR) per Investigator's assessment.
- timeFrame
- up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.