LOGICAN : Randomised phase II study evaluating trifluridine/tipiracil plus oxaliplatin ± nivolumab versus FOLFOX ± nivolumab in patients with HER2 negative locally advanced, recurrent or metastatic gastric, oesophageal or junctional adenocarcinoma

Unicancer31 sites in 1 country118 target enrollmentJune 20, 2024

DrugsOXALIPLATIN NIVOLUMAB Lonsurf 20 mg/8.19 mg film-coated tablets Lonsurf 15 mg/6.14 mg film-coated tablets, Lonsurf 20 mg/8.19 mg film-coated tablets FOLINIC ACID CAPECITABINE LEVOLEUCOVORIN FLUOROURACIL Lonsurf 15 mg/6.14 mg film-coated tablets TRIFLUOROTHYMIDINE

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Unicancer
Enrollment: 118
Locations: 31
Primary Endpoint: PFS defined as the time from the date of randomisation to date of disease progression (radiological or clinical) or death from any cause, whichever occurs first. Patients without tumour progression or death at the time of analysis will be censored at the date of their last tumour assessment.
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective is to evaluate the superiority of trifluridine/tipiracil + oxaliplatin ± nivolumab over FOLFOX regimen ± nivolumab in terms of Progression-Free Survival (PFS), in first-line palliative setting, in patients with HER 2 negative locally advanced, recurrent or metastatic gastric, oesophagus or gastroesophageal junction adenocarcinoma.

Registry

euclinicaltrials.eu

Start Date

June 20, 2024

End Date

TBD

Last Updated

11 months ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Unicancer

Responsible Party

Principal Investigator

Nourredine AIT RAHMOUNE

Scientific

Unicancer

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed locally advanced, recurrent or metastatic non resectable adenocarcinoma of the stomach, oesophagus or gastroesophageal junction (GEJ) ineligible to curative treatment.
•Women of childbearing potential must have a negative serum or urine pregnancy test done within 14 days before the first study treatment.
•Patients must agree to use adequate contraception methods for the duration of study treatment and within 6 months after completing treatment.
•Patients must be affiliated to a Social Security System (or equivalent).
•Patient must have signed and dated a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent.
•Availability of archived tumour material for ancillary studies
•No dysphagia or difficulty in swallowing.
•No overexpression/amplification of HER2 (IHC 0 or 1+; if IHC is 2+, HIS must be negative). Known CPS PD-L1 score (result in % with the name of the method used). The microsatellite and MMR status of patient’s tumour (MSI/MSS and pMMR/dMMR) must also be known at the time of screening (IHC and PCR tests have to be done).
•At least one evaluable lesion according to RECIST v1.1 outside any previously irradiated area.
•No prior palliative chemotherapy.

Exclusion Criteria

•Patient with a performance status ECOG PS >
•Interstitial lung disease.
•Prior pneumonitis requiring systemic corticosteroid therapy.
•Active infections.
•Pregnant or breastfeeding woman.
•Participation in another therapeutic trial within the 30 days prior to randomisation.
•Persons deprived of their liberty or under protective custody or guardianship.
•Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia (for men: QTc ≥450 msec, for women: QTc ≥470 msec)
•Active systemic autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enrol.
•Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease

Outcomes

Primary Outcomes

PFS defined as the time from the date of randomisation to date of disease progression (radiological or clinical) or death from any cause, whichever occurs first. Patients without tumour progression or death at the time of analysis will be censored at the date of their last tumour assessment.

Secondary Outcomes

Efficacy endpoints:ORR (according to RECIST v1.1) defined as the percentage of patients with Complete Response (CR) or Partial Response (PR). Patients who discontinue treatment without a tumour assessment will be considered non-responders for the analysis
Efficacy endpoints : Overall survival (OS), defined as the time from date of randomisation to the date of death from any cause. Patients alive at the database cut-off date will be censored at the last date of follow-up.
Safety and tolerability of treatment (NCI-CTCAE version 5.0) determined through the incidence of adverse events, treatment related adverse events, serious adverse Events (SAE), and death.
Time to PS deterioration >2 defined as the time between patient randomisation and the first date when PS>2
Quality of Life (QoL) according to QLQ-C30 questionnaire