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New treatment option for Small Cell Lung Cancer (SCLC)
Official title Adjuvant Chemotherapy and Immunotherapy for Completely Resected Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT07149363
What this study is testing
What is Durvalumab 50 MG/ML?
Durvalumab 50 MG/ML is an investigational medicine, being studied as a potential treatment for small cell lung cancer (sclc).
Also referred to as Imfinzi®, MEDI4736.
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 a phase II trial of adjuvant chemotherapy and immunotherapy for completely resected small cell lung cancer (SCLC).
- Phase 2: a mid-size study of how well it works
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
- Age ≥ 18 years.
- Body weight \>30 kg.
- Must have a life expectancy of at least 12 weeks.
- Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on...
- Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within...
You likely can't join if
- Patients who are receiving any other investigational agents.
- Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
- Prior treatment with durvalumab.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for...
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
See the full eligibility criteria
- Age ≥ 18 years.
- Body weight \>30 kg.
- Must have a life expectancy of at least 12 weeks.
- Must have histologically or cytologically confirmed diagnosis of pathologic T1-T2 N0-1 M0 small-cell lung cancer per the American Joint Committee on Cancer staging system, 8th edition.
- Have completely resected (wedge resection, segmentectomy, lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy) small-cell lung cancer within 78 days of enrollment.
- Complete mediastinal lymph node dissection (MLND) or systematic mediastinal lymph node sampling is required.
- No prior systemic therapies, for small cell lung cancer.
- Post-operative radiation for the resected small cell lung cancer is acceptable per treating physician in the setting of N1 disease, but no other prior radiation for small cell lung cancer.
- ECOG performance status 0-1.
- Patients who are receiving any other investigational agents.
- Concurrent enrollment in another clinical study involving investigational treatment directed to treatment of patients with small cell lung cancer.
- Prior treatment with durvalumab.
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥2 years before the first dose of IP and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Superficial bladder cancer without active disease after treatment.
- Low grade prostate cancer without indication for active treatment.
- Adequately treated carcinoma in situ without evidence of disease.
- Patients with a history of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or insufficiently treated deep venous thrombosis (DVT) within the past 3 months.
- Patients with hemoptysis in excess of 2.5 mL within 2 weeks prior to the first dose of study medication.
- Patients requiring concomitant therapy with phenytoin, phenobarbital, or carbamazepine.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Charlottesville, Virginia, 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 Chicago, Illinois, United States; Boston, Massachusetts, United States; Charlottesville, Virginia, 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.