Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Nerviano Medical Sciences
Study ID
NCT06931626
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NMS-03305293 — DRUG
    Route of administration: Oral
  • Temozolomide — DRUG
    Route 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

Start date
Aug 15, 2025
Status verified
Nov 2025
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 Temozolomide
    NMS-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

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-
Tennessee Oncology, PLLCNashvilleTennessee37203-

Find similar trials in Boston, MA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Massachusetts General Hospital· Boston, MATennessee Oncology, PLLC· Nashville, TN

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