Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Phase 3

New Adjuvant Trial of Chemotherapy vs Chemo-immunotherapy

NCT04564157 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2021-01-13
Last updated
2026-05-05

Condition(s) studied

Non-Small Cell Lung CancerAdjuvant Chemotherapy

Investigational drug(s) / intervention(s)

Carboplatin →Paclitaxel →Nivolumab →

Carboplatin: Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin. Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.

Paclitaxel: Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexa-hidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine. Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC. Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.

Nivolumab: Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains. Route of administration: Intravenous infusion. Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml. Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing. Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 4 cycles. For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles). Subjects should be carefully monitored during nivolumab administration to follow infusion reactions. Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment.

Study summary

This is an open-label, randomised, two-arm, phase III, multi-centre clinical trial.

210 stage IB-IIIA, completely resected, non-small cell lung cancer patients will be enrolled in this trial to evaluate the disease free survival between experimental arm (Adjuvant Chemotherapy-Immunotherapy + maintenance adjuvant Immunotherapy) and control arm (Adjuvant Chemotherapy)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 1\. Patients diagnosed of primary non-small cell lung cancer, histologically confirmed * 2\. Patients should be classified postoperatively in stage IB (=4 cm), II or IIIA according to pathological criteria and according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology. * 3\. Complete surgical resection of the primary NSCLC is also essential. Surgeons are strongly advised to dissect or obtain samples of all accessible lymph node levels, as established in the European Society of Thoracic Surgeons guide . Consequently, at the end of the surgical intervention it is recommended to have obtained samples of a minimum of 3 (three) specific mediastinal ganglionic lobe stations (N2), one of which should include station 7, and at least one N1 station (including those resected with the tumor piece). * 4\. The surgical intervention may consist of a lobectomy, sleeve resection, bilobectomy or pneumonectomy, as determined by the responsible surgeon based on intraoperative findings. Patients who have had only segmentectomies or wedge resections are not considered eligible for participation in this study. * 5\. Preoperative (neoadjuvant) use of platinum-based chemotherapy or other types of chemotherapy are not accepted. * 6\. Preoperative, postoperative, or scheduled radiation therapy is not accepted for a later time. Patients with only N2 disease, who have to receive post-operative adjuvant radiotherapy will not be eligible. * 7\. A minimum of 3 weeks must have elapsed between the surgical intervention performed for the NSCLC and the randomization. Adjuvant treatment must start between the 3rd and the 10th week from surgery. * 8\. ECOG 0-1 * 9\. Patients aged ≥ 18 years * 10\. Correct hematological, hepatic and renal function i. Neutrophils ≥ 1500×109/L ii. Platelets ≥ 100 ×109/L iii. Hemoglobin \> 9.0 g/dL iv. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault).v. AST/ALT ≤ 3 x ULN vi. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 x ULN) vii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters or \>40% predicted value viii. INR/APTT within normal limits. * 11\. Patient consent must be obtained in the appropriate manner as established in the applicable local and regulatory requirements * 12\. Patients must be accessible for treatment and follow-up * 13\. Women of childbearing potential, including women who had their last menstrual period in the last 2 years, must have a negative serum or urine pregnancy test within 3 days before randomization. * 14\. All sexually active men and women of childbearing potential must use a highly effective contraceptive method (two barrier methods or a barrier method plus a hormonal method) during the study treatment and for a period of at least 5 months for females and 7 months for males following the last administration of trial drugs. Exclusion Criteria: * 1\. Patients with a history of other malignant diseases, with the exception of the following: * or properly treated non-melanotic skin cancer * or cancer in situ treated with curative intent * or other malignancies treated with curative intent and without signs of disease for a period of\> 3 years after the end of the treatment and which, in the opinion of the doctor in charge of their treatment, do not present a substantial risk of relapse of the previous malignant disease. * 2\. Patients with ALK, STKB11 o KEAP1 known mutations before inclusion in this trial. * 3\. Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutations before inclusion. Patients with any known EGFR mutation cannot be enrolled in the study. * 4\. Patients with a combination of microcytic and non-small cell lung cancer, a carcinoid lung tumor or large cell neuroendocrine carcinoma. * 5\. Patients that received live attenuated vaccines within 30 days prior to randomization. * 6\. History of a primary immunodeficiency, history of organ allogeneic transplantation, use of immunosuppressive drugs within 28 days before randomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments * 7\. Patients with active or uncontrolled infections or with serious medical conditions or disorders that may not allow patient management as established in the protocol * 8\. Patients who have suffered untreated and / or uncontrolled cardiovascular disorders and / or who have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction in the previous year or ventricular cardiac arrhythmias that require medication, history of atrioventricular conduction of second or third degree). Patients with relevant cardiac history, even when well controlled, should have an LVEF\> 50% in the 12 weeks prior to randomization * 9\. Pregnant or breastfeeding women * 10\. Patients in whom R0 resection cannot be confirmed * 11\. Patients with an active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll * 12\. Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease * 13\. Any positive test result for hepatitis B virus or hepatitis C virus, indicating presence of virus, e.g. Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative) * 14\. History of allergy or hypersensitivity to any of the study drug components * 15\. Prior anti-PD1/L1 treatment

Primary outcome measure(s)

  • The disease-free survival — From the date of randomization to the date of last follow up, assessed up to 60 months
    The length of time from randomization to the earliest event defined as disease recurrence, any new lung cancer (even in the opposite lung), or death from any cause at any known point in time.

Trial sites (30)

FacilityCityRegionStatus
Hospital General Universitario de Alicante Alicante Alicante
ICO Badalona, Hospital Germans Trias i Pujol Badalona Barcelona
Hospital Universitari Quiron Dexeus Barcelona Barcelona
Hospital Universitari Vall d' Hebron Barcelona Barcelona
Hospital de la Santa Creu i Sant Pau Barcelona Barcelona
Hospital Parc Taulí Barcelona Barcelona
ICO Hospitalet L'Hospitalet de Llobregat Barcelona
Hospital de Basurto Bilbao Bilbao
Hospital San Pedro De Alcántara Cáceres Cáceres
Hospital Universitario Virgen de la Arrixaca El Palmar El Palmar
ICO Girona, Hospital Josep Trueta Girona Girona
Hospital Universitario Insular de Gran canaria Las Palmas de Gran Canaria Gran Canaria
Hospital Universitario de Jaén Jaén Jaén
Hospitalario Universitario A Coruña A Coruña La Coruña
Hospital Universitario Lucus Augusti Lugo Lugo
Hospital Clínico San Carlos Madrid Madrid
Hospital Universitario Fundación Jiménez Díaz Madrid Madrid
Hospital Universitario la Paz Madrid Madrid
Hospital Puerta de Hierro Madrid Madrid
Hospital Fundación de Alcorcón Madrid Madrid
Hospital Son Espases Palma de Mallorca Palma de Mallorca
Complejo Hospitalario de Navarra Pamplona Pamplona
Hospital Universitario Nuestra Señora La Candelaria Santa Cruz de Tenerife Santa Cruz de Tenerife
Hospital Virgen del Rocío Seville Sevilla
Instituto Valenciano De Oncología Valencia Valencia
Hospital Clínico de Valencia Valencia Valencia
Hospital General Universitario de Valencia Valencia Valencia
Hospital Universitario La Fe Valencia Valencia
Complexo Hospitalario Universitario De Vigo Vigo Vigo
Hospital Universitario Cruces Barakaldo Vizcaya
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04564157 on ClinicalTrials.gov ↗ ← All trials in Spain