Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 1 / Phase 2: testing Lurbinectedin for Small Cell Lung Cancer ( SCLC )
This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Lurbinectedin, or Osimertinib. The registry lists allocation as randomized. This open-label, Phase I/II trial is studying the safety and effectiveness of an experimental drug combination, lurbinectedin with osimertinib, against a rare type of cancer known as transformed small cell lung cancer (SCLC).
They plan to enroll about 16 people at Indianapolis. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Phase I/II Trial of Lurbinectedin With Osimertinib in Transformed Small Cell Lung Cancer
Primary outcome (registry wording): Grade 3 or dose-limiting toxicities
Who it is for (from inclusion criteria)
Ages 18 Years to any
Must have a histologically or cytologically confirmed transformation to small cell lung carcinoma/cancer
Note: Tissue specimens from archival tissue are encouraged but not required for enrollment
Must have measurable disease per RECIST (version 1.1)
how well you can do daily activities (ECOG score) ≤ 2
Adequate laboratory functions on baseline testing within 21 days of enrollment, as defined as:
a. Hematologic parameters: i. Absolute neutrophil count (ANC) ≥ 1.5x109/L ii. Platelet count (Plt) ≥ 100x109/L b. Hepatic parameters: i. Total bilirubin ≤ 1.5x upper limit of normal (ULN); for patients with suspected/documented Gilbert's syndrome, total bilirubin ≤ 3x ULN
ii. AST ≤ 3x ULN. iii. ALT ≤ 3x ULN. c. Renal parameters: i. Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR, calculated per institutional standards) should be \> 30 mL/min
Who the registry excludes
Patients who have tumors harboring EGFR exon 20 insertion alterations, EGFR C797S, or known mechanisms of resistance to osimertinib (i.e., MET amplification) aside from histologic transformation to SCLC
Patients who are pregnant (treatment can cause fetal harm) and/or breastfeeding
Symptomatic or unstable brain metastases, requiring \> 2 mg dexamethasone orally daily, or received palliative radiation to the CNS within 2 weeks of enrollment
Patients with known history of interstitial lung disease (ILD) or pneumonitis (\> grade 1) or ILD/pneumonitis (\> grade 1) related to antineoplastic drug treatment
Prior history of documented Stephen Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), erythema multiforme major (EMM), or aplastic anemia on osimertinib
History of congenital long QTc syndrome or mean resting QTc \>500 msec at screening with two replicated EKGs at baseline screening for the study
History of ongoing unstable or uncontrolled cardiac conditions, including documented cardiomyopathy or symptomatic congestive heart failure (defined as New York Heart Association (NYHA) class III or IV)
Background: The National Cancer Institute Surgery Branch (NCI-SB) has developed experimental therapies that involve taking white blood cells from patients' tumor or from their blood, growing them in the laboratory in large numbers, and then giving the cells back to the patient. Objective: This study will allow patients to under screening and evaluation for participation in NC-SB Protocols.
This study will collect blood from patients with cancer to study the level of cells which decrease the immune response (suppressor cells) before and after chemotherapy. Patients 18 years of age and older with cancer may participate.
The purpose of this research study is to determine the genetic changes and immunologic changes that are involved in the development and progression of bronchogenic lung cancer.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07153055?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07153055?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.