Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroen… (NCT07738159) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma
92 participantsStarted 2026-08-01
Plain-language summary
The aim of this prospective, randomized, controlled clinical trial is to evaluate the efficacy and safety of iparomlimab and tuvonralimab injection (QL1706) plus lenvatinib and etoposide-based platinum chemotherapy, consisting of etoposide plus cisplatin or carboplatin, compared with etoposide-based platinum chemotherapy alone as first-line treatment for patients with extrapulmonary neuroendocrine carcinoma. Potential predictive biomarkers will also be explored through analyses of tumor tissue, peripheral blood, and relevant clinical and pathological data.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically and/or cytologically confirmed locally advanced unresectable or metastatic extrapulmonary neuroendocrine carcinoma. Eligible primary sites include the gastrointestinal tract, pancreas, biliary tract, and other extrapulmonary organs. Neuroendocrine carcinoma of the digestive system must be diagnosed according to the 2019 World Health Organization Classification of Tumours of the Digestive System.
. Age ≥18 years, with no restriction on sex.
. Life expectancy of at least 12 weeks.
. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
. Patients must not have received prior first-line systemic anticancer therapy for advanced or metastatic disease. Patients who previously received adjuvant therapy following curative surgery are eligible, provided that disease recurrence occurred more than 6 months after completion of adjuvant therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
. No severe complications related to the primary tumor, including perforation, obstruction, or major bleeding that cannot be adequately controlled with medical treatment.
. Adequate organ function, as demonstrated by the following laboratory results obtained within 7 days before enrollment. Patients must not have received blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other supportive treatment affecting the relevant laboratory parameters within 14 days before the first dose of study treatment: Hemoglobin ≥90 g/L; Platelet count ≥75 × 10⁹/L; White blood cell count ≥3.0 × 10⁹/L; Absolute neutrophil count ≥1.5 × 10⁹/L; Total bilirubin ≤1.5 × the upper limit of normal (ULN); Serum creatinine ≤1.5 × ULN; Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN, or ≤5 × ULN in participants with liver metastases.
Exclusion criteria
. Histologically confirmed neuroendocrine tumor, mixed adenoneuroendocrine carcinoma, or other non-neuroendocrine carcinoma pathological types.
. History of another malignancy with a disease-free interval of less than 5 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or a gastrointestinal tumor confirmed to have been cured by endoscopic mucosal resection.
. Uncontrolled hypertension despite medical treatment, defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg.
. Urine protein ≥2+ on routine urinalysis or 24-hour urinary protein ≥1 g.
. Major surgery within 4 weeks before enrollment, excluding diagnostic biopsy, or an incompletely healed surgical wound.
. Severe gastrointestinal disorders that may affect drug absorption, including but not limited to peptic ulcer, ulcerative colitis, active gastrointestinal bleeding, gastrointestinal obstruction, or severe diarrhea.
. A history of severe bleeding within the previous 3 months, defined as a single bleeding episode of \>30 mL; hemoptysis within the previous 1 month, defined as a single episode of \>5 mL; or a thromboembolic event within the previous 12 months, including pulmonary embolism or cerebral infarction.
. Severe cardiovascular disease, including but not limited to acute myocardial infarction, unstable angina, heart failure, ventricular arrhythmia requiring medical treatment, left ventricular ejection fraction \<50%, or New York Heart Association cardiac functional class II or higher.