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New treatment option for Small Cell Lung Cancer
Official title Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT06931626
What this study is testing
What is NMS-03305293?
NMS-03305293 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed extensive-stage Small Cell Lung Cancer (SCLC); must have failed prior front-line platinum-based therapy including immune...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by...
- The interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever longer.
- All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute Common Terminology Criteria for...
You likely can't join if
- Current enrollment in another treatment clinical trial.
- Current treatment with other anticancer agents or devices.
- Major surgery, other than surgery for recurrent SCLC, within 4 weeks prior to treatment start.
- Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow.
- Histologically transformed SCLC, i.e. tumors initially diagnosed as Non-Small Cell Lung Cancer (NSCLC) or mixed lung adenocarcinoma
- Known paraneoplastic syndrome uncontrolled or that required therapeutic changes (either new/acute or chronic) in the 14 days prior to study entry
See the full eligibility criteria
- 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...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patient must have progressed radiographically on or after their most recent line of anticancer therapy and have measurable disease as defined by RECIST v1.1 (radiologically measured by the Investigator).
- The interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever longer.
- All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 Grade ≤ 1 or to the baseline...
- Patients must use highly effective contraception or true abstinence.
- Ability to swallow capsules intact (without chewing, crushing, or opening).
- Current enrollment in another treatment clinical trial.
- Current treatment with other anticancer agents or devices.
- Major surgery, other than surgery for recurrent SCLC, within 4 weeks prior to treatment start.
- Patients with prior wide-field radiotherapy (RT) affecting at least 20 percent of the bone marrow.
- Histologically transformed SCLC, i.e. tumors initially diagnosed as Non-Small Cell Lung Cancer (NSCLC) or mixed lung adenocarcinoma
- Known paraneoplastic syndrome uncontrolled or that required therapeutic changes (either new/acute or chronic) in the 14 days prior to study entry
- Use of full-dose anticoagulants unless the International Normalized Ratio (INR) or a Partial Thromboplastin Time (PTT) is within therapeutic limits (according to the medical standard in the institution) and the patient...
- Treatment with concomitant medications known to be sensitive substrates of CYP2D6 and CYP2C19 that cannot be replaced with another treatment.
- Treatment with systemic immune modulators such as corticosteroids at prednisone equivalent dose of \> 10 mg/day, cyclosporine and tacrolimus or radiotherapy within 28 days before treatment start.
- Breast-feeding women or women planning to breast feed during the study or within 3 months after study treatment.
- Known hypersensitivity to any component of NMS-03305293 or Temozolomide (TMZ) drug formulations.
- Known active, life-threatening or clinically significant uncontrolled systemic infection (bacterial, fungal, viral including Human Immunodeficiency Virus [HIV] positivity or Hepatitis B Virus [HBV] or Hepatitis B Virus...
- Patients with QT interval using Fridericia standard (QTcF) interval \>450 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc...
- Known active gastrointestinal disease (e.g., documented gastrointestinal ulcer, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes or structural issues or ulcer that would...
- Any of the following in the previous 6 months: myocardial infarction, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic...
- History of long QT disorder or familial sudden death syndromes or related syndromes in the opinion of the Investigator.
- Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and/or cone biopsied or post curative intention in situ carcinoma of the cervix uteri and/or superficial bladder...
- Symptomatic, or untreated central nervous system (CNS) lesions except stable and well controlled with no neurological symptoms; patients receiving corticosteroids to control neurological symptoms should be on stable...
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.