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New treatment option for Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Official title Second-line Immunotherapy for ES-SCLC
ClinicalTrials.gov ID: NCT06853678
What this study is testing
What is Adebrelimab?
Adebrelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for extensive stage small cell lung cancer (es-sclc).
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
- At present, the first-line standard treatment for patients with extensive-stage small cell lung cancer (ES-SCLC) is immunotherapy combined with chemotherapy. For patients who relapse within 6 months after first-line chemotherapy, conventionally recommended chemotherapy drugs include topotecan, irinotecan, gemcitabine, paclitaxel or vinorelbine, etc., but due to limited benefits to patients, patients are also recommended to participate in relevant clinical studies.
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 old, male or female;
- ECOG PS score 0-1 points;
- Expected survival period is not less than 12 weeks;
- Patients with pathologically (histologically or cytologically) confirmed small cell lung cancer (according to the 2015 classification of the World...
- Patients with extensive stage small cell lung cancer confirmed by imaging (staging according to the eighth edition of TNM staging);
You likely can't join if
- Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis...
- Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, untreated active hepatitis B (HBsAg...
- people who need systemic treatment with corticosteroids (\>10 mg/day of prednisone or equivalent dose of similar hormones) or other...
- people who received live attenuated vaccines within 4 weeks before the first dose or planned to receive them during the study;
- people who have previously or are currently using any other anti-tumor treatment for SCLC;
- people who have suffered from malignant tumors other than SCLC in the past 5 years, excluding fully treated cervical carcinoma in situ, basal cell or...
See the full eligibility criteria
- Age ≥ 18 years old, male or female;
- ECOG PS score 0-1 points;
- Expected survival period is not less than 12 weeks;
- Patients with pathologically (histologically or cytologically) confirmed small cell lung cancer (according to the 2015 classification of the World Health Organization);
- Patients with extensive stage small cell lung cancer confirmed by imaging (staging according to the eighth edition of TNM staging);
- With measurable lesions (according to RECIST 1.1 standards, the long diameter of the tumor lesion on CT scan is ≥ 10mm);
- Need to have failed standard first-line treatment before enrollment;
- Agree to collect tumor histological specimens required for this study and use them in related research;
- Main organ function is normal, without severe abnormal blood, heart, lung, liver, kidney function and immunodeficiency diseases.
- Female people of childbearing potential must undergo a serum or urine pregnancy test within 72 hours before starting the trial drug, and the result must be negative, and they must be willing to use a medically approved...
- people voluntarily join this study and sign the Informed Consent Form (ICF), have good compliance, and can follow up the how well it works and adverse reactions as required by the protocol
- Any active autoimmune disease or history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis...
- Suffering from congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, untreated active hepatitis B (HBsAg positive or HBV DNA ≥ 500 IU/ml and abnormal liver function), hepatitis...
- people who need systemic treatment with corticosteroids (\>10 mg/day of prednisone or equivalent dose of similar hormones) or other immunosuppressants within 14 days before the first use of the trial drug;
- people who received live attenuated vaccines within 4 weeks before the first dose or planned to receive them during the study;
- people who have previously or are currently using any other anti-tumor treatment for SCLC;
- people who have suffered from malignant tumors other than SCLC in the past 5 years, excluding fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical...
- Evidence of past or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-induced pneumonia, and severe lung function impairment;
- Suffering from grade II or above myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms for men and ≥470ms for women). According to NYHA standards, patients with...
- Urinalysis indicated urine protein ≥ (++), or 24-hour urine protein ≥ 1.0 g;
- Patients with thrombotic diseases requiring long-term anticoagulation therapy with warfarin or heparin, or requiring long-term antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day);
- Systemic antibiotics used for ≥7 days within 4 weeks before the first dose, or unexplained fever \>38.5℃ during the screening period/before the first dose (fever caused by tumors can be included in the study as...
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Pregnant or lactating women; patients of fertile potential who are unwilling or unable to take effective contraceptive measures;
- Known allergic reactions, hypersensitivity reactions, or intolerance to carrelizumab and other monoclonal antibodies, pemetrexed, albumin-paclitaxel, prophylactic medications, or their excipients;
- Any condition that the investigator believes may harm the subject or cause the subject to be unable to meet or perform the study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 Tianjin, Tianjin Municipality, 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.