Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Iparomlimab and tuvonralimab injection (QL1706) + Lenvatinib + EP/EC
DrugParticipants will receive iparomlimab and tuvonralimab injection (QL1706) at 5 mg/kg intravenously on Day 1, etoposide at 100 mg/m² intravenously on Days 1-3, and either cisplatin at 75 mg/m² intravenously per cycle or carboplatin at AUC 5 intravenously on Day 1 of each 21-day cycle. Lenvatinib will be administered orally once daily at 8 mg or 4 mg, as determined by the safety findings from the safety run-in phase. After six cycles of combination treatment, participants without disease progression or unacceptable toxicity will continue maintenance treatment with QL1706 plus lenvatinib until disease progression, unacceptable toxicity, or another protocol-defined reason for discontinuation.
EP/EC
DrugPatients will receive etoposide 100 mg/m² intravenously on Days 1-3, together with either cisplatin 75 mg/m² intravenously per cycle or carboplatin AUC 5 intravenously on Day 1 of each 21-day cycle.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Iparomlimab and tuvonralimab injection (QL1706) + Lenvatinib + EP/ECExperimental treatment 1 intervention
Group B: EP/ECActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
6-month PFS rate
The 6-month PFS rate is defined as the proportion of patients who are alive and free from radiographic disease progression at 6 months after enrollment, as assessed by blinded independent radiologic review. Disease progression or death from any cause, whichever occurs first, will be considered a progression-free survival event.
Time frame
Up to 24 monthsSecondary outcomes
1
PFS
PFS is defined as the time from enrollment to the first documented radiographic disease progression, as assessed by blinded independent radiologic review, or death from any cause, whichever occurs first.
Time frame
2 years2
OS
OS is defined as the time from enrollment to death from any cause.
Time frame
2 years3
ORR
ORR is defined as the proportion of patients whose best overall response is complete response or partial response, as assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent radiologic review.
Time frame
2 years4
DCR
DCR is defined as the proportion of participants whose best overall response is complete response, partial response, or stable disease, as assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 by blinded independent radiologic review.
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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