Is NCT07174583 recruiting in Orlando, FL?

Yes, NCT07174583 is currently recruiting participants at its Orlando, FL location. This small cell lung cancer clinical trial is actively enrolling qualified participants.

How do I join the small cell lung cancer clinical trial in Orlando?

To join this clinical trial in Orlando, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Orlando clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Small Cell Lung Cancer Clinical Trial in Orlando, FL

Who Can Participate

Inclusion Criteria

Are willing to participate in this clinical study, understand the study procedures, and are able to sign the written ICF.

Subjects with histologically or cytologically confirmed ES- SCLC, neuroendocrine carcinoma (NEC), DLL3+ solid tumors, are eligible per protocol. Subjects must have radiologically progressed or recurred after previous standard treatment. For SCLC, this includes platinum-based therapy and programmed death-1/programmed death-ligand 1 inhibitors (except for subjects who refuse, or are judged by the Investigator to be unsuitable, or were intolerant to immunotherapy and chemotherapy may enroll to receive monotherapy or IDE161 combination.

Subjects with NEC, this includes

High-grade gastroenteropancreatic NEC

NEC of the prostate

Small cell NEC of any other organ

Merkel cell carcinoma

Transformed non-small cell adenocarcinoma of the lung (including but not limited to epidermal growth factor receptor or Kirsten rat sarcoma viral oncogene homolog mutated adenocarcinoma of the lung post progression on targeted therapies

Any other NEC that does not meet any of the indications noted above.

Subjects with other solid tumors demonstrated to express moderate/high expression of DLL3 including metastatic melanoma, Grade 3 gastrointestinal and pancreatic NETs, and pulmonary carcinoids. • metastatic melanoma

Subjects will be required to provide blood/tumor tissue samples for biomarker testing.

Have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1.

Have life expectancy \> 3 months.

Have adequate bone marrow and organ function within 7 days of the first dose (no use of any blood components and/or cell growth factors within 14 days prior to the start of the study treatment).

Women of childbearing potential (WOCBP) must agree to take highly effective contraceptive measures from signing of consent through 8 months after the last dose of IDE849; men with partners of child-bearing potential must use effective contraception through 5 months after the last dose.

Exclusion Criteria

Have mixed SCLC and NSCLC histology are not allowed (SCLC with components of large cell NEC are eligible). Participants with limited stage SCLC are ineligible.

Subjects with locally untreated (radiotherapy or surgery) or active central nervous system (CNS) tumor metastasis.

Have had other malignancies within 2 years prior to the first dose, except adequately treated carcinoma in situ (cervical, breast, or other), basal cell or squamous cell skin cancer, localized prostate cancer after curative therapy with no recurrence, or papillary thyroid cancer after curative resection; other prior or concurrent malignancies may be eligible with Medical Monitor review and approval.

Have uncontrolled tumor-associated pain.

Have severe cardiovascular and cerebrovascular disease

Have history of clinically significant bleeding within 3 months before the first study dose.

Have history of interstitial pneumonitis during previous treatment; current noninfectious pneumonitis requiring steroid therapy; known or suspected interstitial pneumonitis as seen on screening imaging; other moderate to severe lung diseases seriously affecting respiratory function within 3 months before the first dose, including, but not limited to, idiopathic pulmonary fibrosis and organizing pneumonia/obliterative bronchiolitis.

Have history of immunodeficiency, with a positive human immunodeficiency virus (HIV) test at screening (HIV antibody positive and HIV-RNA above the lower limit of detection of the analytical method).

Subjects with known or suspected viral hepatitis.

Have a history of active tuberculosis within 1 year before enrollment.

For participants enrolling to receive the combination with durvalumab, must not be deemed by the Investigator to be unsuitable to receive immunotherapy, or have had any prior intolerance to PD-1/PD-L1 inhibitor therapy, or have had any prior Grade 2 or higher myocarditis or any other Grade 3 or higher immune-related AE. If the participant has had a prior immune-related AE, must have recovered to Grade \< 1.

For participants enrolling to receive the combination with IDE161, must not have had prior GI or upper bowel removal or any other gastrointestinal disorder or defect (eg, malabsorption disorder such as Crohn's disease or ulcerative colitis), that would interfere with absorption of IDE161.

For patients receiving a combination with carboplatin, be deemed by the Investigator to be unsuitable to receive platinum-based chemotherapy, or have had intolerance to platinum-based chemotherapy

Have received chemotherapy within 3 weeks of first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; for small molecule treatments within 2 weeks before the first dose of the IMP or within 5 half lives of the drug (whichever is longer); other investigational products within 4 weeks or within 5 half-lives of the drug (whichever is longer) unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study. Participants who received an immunotherapy agent (eg, PD-1/PD-L1 inhibitor) immediately prior to study enrollment must have documented radiologic disease progression as per the Investigator prior to the first dose of IMP

Administration of any of the following:

Use of drugs that are inhibitors of P-gp, BCRP, and OATPIB1/OATP1B3

Use of drugs with known risk of QT prolongation within 5 half-lives of their administration.

For participants enrolling to receive the combination with IDE161:

Use of drugs of narrow therapeutic index that are sensitive substrates of MATE2-K, BCRP, and P-gp

Use of known moderate and strong CYP3A4/5 inducers and inhibitors is not permitted

Administration of PPIs

Use of an H2 blocking agent

Use of a local antacid

Use of drugs with a known risk of QT prolongation

Have prior treatment with DLL3 ADC with a Topo1 inhibitor payload (except for participants enrolling to receive the IDE161 combination).

For participants enrolling to receive the combination with durvalumab, have history of prior intolerance to PD-1/PD-L1 inhibitors.

Have received \> 30 Gy of chest radiotherapy within 8 weeks prior to the first dose of the IMP, \> 30 Gy of non-chest radiotherapy within 14 days prior to the first dose (subjects who have completed radiotherapy for brain metastases within 14 days prior to the first dose can be enrolled and palliative radiotherapy for other sites of ≤ 30 Gy is allowed if completed more than 14 days prior to the first dose).

Have undergone major surgery or experienced significant trauma within 4 weeks prior to the first dose.

Female subjects who are pregnant, lactating, or planning to become pregnant during the study period to 8 months after the last dose of the IMP.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Orlando?

Yes, this clinical trial (NCT07174583) has an active research site in Orlando, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Small Cell Lung Cancer Treatment Options in Orlando, FL

If you're searching for small cell lung cancer treatment options in Orlando, FL, this clinical trial (NCT07174583) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Orlando research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced small cell lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all small cell lung cancer clinical trials near you to find additional studies recruiting in your area.

Small Cell Lung Cancer Clinical Trial in Orlando, FL

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About This Small Cell Lung Cancer Study in Orlando