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New treatment option for Small Cell Lung Cancer Limited Stage
Official title Durvalumab as Consolidation for Patients LS-SCLC
ClinicalTrials.gov ID: NCT07055581
What this study is testing
What is Induction Durvalumab +etoposide/platinum +Radiochemotherapy+ durvalumab maintenance?
Induction Durvalumab +etoposide/platinum +Radiochemotherapy+ durvalumab maintenance is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for small cell lung cancer limited stage.
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
- Small-Cell Lung Cancer (SCLC) accounts for 10% to 15% of new lung cancers and is a highly aggressive neuroendocrine tumor. In the past 30 years, the treatment of SCLC has made very limited progress, and basically made breakthroughs in radiotherapy and chemotherapy.
- 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
- 1.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form...
- 2.Histologically or cytologically confirmed small cell lung cancer
- 3.Limited-stage, defined as stage I-III SCLC (T any, N any, M0). Patients who are Stage I or II must be medically inoperable as determined by...
- 4.Age \> 18 years.
- 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
You likely can't join if
- 1.Patients with extensive disease small-cell lung cancer.
- 2.Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer.
- 3.Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive...
- 4.Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values.
- 5.Any concurrent chemotherapy other than study treatment, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy...
- 6.History of allogenic organ transplantation.
See the full eligibility criteria
- 1.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- 2.Histologically or cytologically confirmed small cell lung cancer
- 3.Limited-stage, defined as stage I-III SCLC (T any, N any, M0). Patients who are Stage I or II must be medically inoperable as determined by investigator.
- 4.Age \> 18 years.
- 5.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 6.Adequate normal organ and marrow function.
- 7.Must have a life expectancy of at least 12 week.
- 8.At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed...
- 1.Patients with extensive disease small-cell lung cancer.
- 2.Patients who previously received radiotherapy to the thorax or chemotherapy for small cell lung cancer.
- 3.Any previous diagnosis of transformed non-small cell lung cancer (NSCLC), epidermal growth factor receptor (EGFR) activating mutation positive NSCLC that has transformed to SCLC, or mixed SCLC NSCLC histology...
- 4.Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values.
- 5.Any concurrent chemotherapy other than study treatment, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy)...
- 6.History of allogenic organ transplantation.
- 7.Active or prior documented autoimmune or inflammatory disorders.
- 8.Uncontrolled intercurrent illness.
- 9.History of leptomeningeal carcinomatosis.
- 10.Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart)
- 11.History of active primary immunodeficiency
- 12.Known active hepatitis infection, positive hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or HBV core antibody (anti-HBc), at screening. Participants with a past or resolved HBV...
- 13.Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
- 14.Prior treatment in a previous durvalumab clinical study.
- 15.Known allergy or hypersensitivity to IP or any excipient.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
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 Zhengzhou, Henan, China; Wuhan, Hubei, China. 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.