Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer
Part of paid clinical trials in Peoria, Illinois.
- Sponsor
- Nerviano Medical Sciences
- Study ID
- NCT06931626
- Phase
- PHASE1
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- NMS-03305293 — DRUGRoute of administration: Oral
- Temozolomide — DRUGRoute of administration: Oral Commercially available Temozolomide
Study Details
This is an open-label study of NMS-03305293 with Temozolomide (TMZ) in patients with Small Cell Lung Cancer (SCLC). The aim of this study is to determine the safety and tolerability, as well as to evaluate the anti-tumor efficacy and pharmacokinetics of NMS-03305293 in combination with TMZ.
Key Dates
- First listed
- Apr 17, 2025
- Start date
- Aug 15, 2025
- Status verified
- Jul 2026
- Primary completion
- Oct 30, 2026
- Completion
- Feb 28, 2027
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: NMS-03305293 and TemozolomideNMS-03305293 will be dosed orally on days 1-28 of each 28-day cycle, at 100 mg twice daily. Temozolomide will be dosed orally on days 1-5 of each 28-day cycle, at 150 mg/m\^2, based on patients' body surface area.
Primary Outcome Measure
Number of Participants with Adverse Events (AEs) [ Time Frame: Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 12 months) ]
Central Contacts
- Domenico Roberti+39 0331-581111
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| OSF Saint Francis Medical Center | Peoria | Illinois | 61637 | - |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | - |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | - |
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