GoKawiilLap-NET1 clinical trial
Study design and participants
Lap-NET1 is a multicentric, prospective, single-arm phase 1b trial. This study included a safety lead-in phase to confirm the recommended dose of NP137 in combination with mFOLFIRINOX (ClinicalTrials.gov identifier: NCT05546853). Patients were enrolled and treated between March 2023 and June 2024 at nine sites in France.
Eligible patients were 18 years and older with histological or cytological confirmed diagnosis of locally advanced PDAC. The tumour was considered unresectable according to the NCCN Guidelines v2.2021. Prior systemic therapy, radiation therapy or resection for pancreatic cancer were not allowed. Patients had an ECOG performance status of 0 or 1 and a measurable disease per RECIST v1.1.
Ethics statement
The protocol was approved by the ethical committee and the French National Agency for Medicines and Health Products Safety (ANSM); the approvals were recorded via the EU Clinical Trials Information System (CTIS) (CTIS number 2022-500905-42-00). The trial was registered at http://www.clinicaltrials.gov under ID NCT05546853. All participants provided written informed consent prior to enrolment.
Procedures
During the safety lead-in phase, 3 to 12 patients would be enrolled to confirm the dose of 14 mg kg−1 (intravenously) every 14 days for NP137 in combination with mFOLFIRINOX (oxaliplatin (85 mg m−2), calcium levofolinate (200 mg m−2), irinotecan (150 mg m−2) on day 1 and 5-fluorouracil (2.4 g m−2 over 46 h)) administered every 14 days.
After the safety lead-in, 40 additional patients were treated with intravenous NP137 at the recommended dose, associated with modified FOLFIRINOX every 14 days until progression or the maximum treatment duration is reached (6 months, 12 cycles), or unacceptable tolerability. After completion, the investigator chose whether to stop the treatment and follow the patient, or use a follow-up treatment such as radiotherapy, radio-chemotherapy, maintenance chemotherapy or surgical resection (for eligible patients). Patients were followed up until progression and death.
End-points
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