Actively Recruiting
Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer
Led by Nerviano Medical Sciences · Updated on 2025-11-12
10
Participants Needed
2
Research Sites
80 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed extensive-stage Small Cell Lung Cancer (SCLC); must have failed prior front-line platinum-based therapy including immune therapy with relapse within 6 months followed by failed tarlatamab therapy if appropriate, and no more than 3 total prior lines of systemic therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Radiographic progression on or after most recent anticancer therapy and measurable disease per RECIST v1.1
- At least 2 weeks or 5 half-lives interval from prior antitumor treatment
- All acute toxic effects of prior therapy resolved to NCI CTCAE version 5.0 Grade 1 or baseline laboratory values
- Use of highly effective contraception or true abstinence
- Ability to swallow capsules intact without chewing, crushing, or opening
You will not qualify if you...
- Current enrollment in another interventional clinical trial
- Treatment with other anticancer agents or devices
- Major surgery within 4 weeks prior to treatment start, except surgery for recurrent SCLC
- Prior wide-field radiotherapy affecting at least 20% of bone marrow
- Histologically transformed SCLC (initially diagnosed as NSCLC or mixed lung adenocarcinoma)
- Uncontrolled paraneoplastic syndrome requiring recent therapeutic changes
- Use of full-dose anticoagulants without stable dosing or therapeutic INR/PTT
- Treatment with systemic immune modulators or radiotherapy within 28 days before treatment
- Breast-feeding or planning to breast feed during study or within 3 months after treatment
- Known hypersensitivity to components of NMS-03305293 or Temozolomide
- Active, life-threatening or uncontrolled systemic infection requiring treatment, except controlled HIV/AIDS
- QTcF interval over 450 ms or risk factors for torsade de pointes
- Active gastrointestinal disease or malabsorption syndromes affecting drug absorption
- Serious cardiovascular events or bleeding disorders within previous 6 months
- History of long QT disorder or familial sudden death syndromes
- Active second malignancy except some treated skin or cervical cancers
- Symptomatic or untreated central nervous system lesions, except stable and well controlled
- Other severe acute or chronic medical or psychiatric conditions increasing risk or interfering with study or interpretation
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
Research Team
D
Domenico Roberti
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here