Study of NMS-03305293 in Adult Patient With Relapsed Small Cell Lung Cancer
Study of NMS-03305293, a Non-Trapping PARP1-Specific PARP Inhibitor in Relapsed Small Cell Lung Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests NMS-03305293 with temozolomide (TMZ) in adults whose small cell lung cancer has come back after treatment. Researchers will check side effects, how well the drugs fight cancer, and how the body handles NMS-03305293.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have small cell lung cancer that has spread widely, confirmed by a tissue test.
- Have cancer that returned within 6 months after first treatment with platinum-based chemotherapy and immune therapy. Tarlatamab must also have failed, if available and suitable. Have had no more than 3 rounds of different drug treatments. The sponsor may allow a longer time before the cancer returned.
- Be able to care for yourself and be out of bed or a chair for at least half of your waking hours.
- Have cancer that grew on scans during or after your latest treatment and can be measured on scans.
- Wait long enough after your last cancer treatment: usually at least 2 weeks for chemotherapy and certain other drugs, or 4 weeks for biologic drugs. Longer waits may be needed based on how long the drug stays in your body.
- Side effects from past treatment must be mild or back to the study's allowed starting levels, except for hair loss.
- Use highly effective birth control or fully avoid sex that could cause pregnancy.
- Be able to swallow capsules whole without chewing, crushing, or opening them.
Who can't join
- Be in another treatment study or receive other cancer drugs or devices. Certain medicines that affect drug breakdown, immune function, or heart rhythm may also prevent joining.
- Have had major surgery within 4 weeks, except surgery for returning small cell lung cancer; radiation within 28 days; or past radiation covering at least 20% of the bone marrow.
- Have small cell lung cancer that changed from another lung cancer type, another active cancer except certain treated or surface cancers, or brain or spinal cord tumors that do not meet the study's stability rules.
- Have an uncontrolled illness caused by the cancer that needed treatment changes within 14 days, or use full-dose blood thinners without stable dosing and blood tests in the allowed range.
- Be breastfeeding or plan to breastfeed during treatment or within 3 months afterward, or have a known allergy to either study drug's ingredients.
- Have a serious active infection needing treatment. HIV-related illness may be allowed if controlled with medicine and undetectable for more than 6 months.
- Have certain heart rhythm problems or risks, or have had a heart attack, unstable chest pain, artery bypass surgery, heart failure with symptoms, stroke, blood clot, bleeding disorder, or inflammation and scarring of the lungs within 6 months.
- Have an active stomach or bowel problem that affects drug absorption, or another serious health condition or test result that makes joining unsafe. Other study rules may apply.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion 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 therapy, if available and appropriate, and no more than 3 total prior lines of systemic therapy (therapy terminated due to toxicity or drug shortage, in the absence of Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 progression, will be considered part of the same line). Sponsor may opt to allow history of treatment free interval from front-line longer than 6 months . * 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 for small-molecule agents and chemotherapies. For prior biologic therapy, including monoclonal antibodies, antibody-drug conjugates, immune checkpoint inhibitors, and bispecific antibodies, the interval should be at least 4 weeks or 5 half-lives, whichever is longer, unless otherwise justified based on the agent's known pharmacokinetics, pharmacodynamics, and residual toxicities. * 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 laboratory values as defined in the protocol. * Patients must use highly effective contraception or true abstinence. * Ability to swallow capsules intact (without chewing, crushing, or opening). Exclusion Criteria - * Current enrollment in another interventional 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 has been on a stable dose of anticoagulants for at least 2 weeks before enrollment. * 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 \[HCV\] infections) requiring systemic treatment; HIV or Acquired Immune Deficiency Syndrome (AIDS)-related illness are allowed as long as controlled more than 6 months to undetectable on anti-HIV medications. * 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 interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment prior to enrollment is mandatory. If concomitant use of anti-emetics is considered essential for the care of the patients, follow instruction in this protocol * 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 impact on drug absorption. * 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 attack, pulmonary embolism, deep vein thrombosis, active bleeding disorder and interstitial lung disease. * 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 cancer. * 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 doses for at least 14 days before study entry. * 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 interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study or could compromise protocol objectives in the opinion of the Investigator and/or the Sponsor. NOTE: Other protocol defined inclusion and exclusion criteria may apply.
Study sites (3)
IL
- OSF Saint Francis Medical Center · Peoria, IL 61637More trials in Peoria
MA
- Massachusetts General Hospital · Boston, MA 02114More trials in Boston
TN
- Tennessee Oncology, PLLC · Nashville, TN 37203More trials in Nashville