Phase
Condition
Carcinoma
Treatment
Zimberelimab
Cisplatin
Carboplatin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients diagnosed of primary non-small cell lung cancer, histologicallyconfirmed.
- Patients should be classified postoperatively in stage IB, IIA, IIB, IIIA orIIIB (N2) according to pathological criteria (pTNM) and according to 8thversion of the International Association for the Study of Lung Cancer StagingManual in Thoracic Oncology
- Complete surgical resection (R0) of the primary NSCLC is also essential.Surgeons are strongly advised to dissect or obtain samples of all accessiblelymph node levels, as established in the European Society of Thoracic Surgeonsguide. Consequently, at the end of the surgical intervention it is recommendedto have obtained samples of a minimum of 3 specific mediastinal ganglionic lobestations (N2), one of which should include station 7, and at least one N1station
- The surgical intervention may consist of a lobectomy, sleeve resection,bilobectomy or pneumonectomy, as determined by the responsible surgeon based onintraoperative findings. Patients who have had only segmentectomies or wedgeresections are not considered eligible for participation in this study exceptif R0 resection can be confirmed.
- Only patients that do not achieve pathological complete response (pCR) seen inthe surgical piece after neoadjuvant therapy are eligible.
- Preoperative (neoadjuvant) use of platinum-based chemotherapy + immunotherapy (anti PD-1) is mandatory.
- Preoperative, postoperative, or scheduled radiation therapy is not accepted fora later time. Patients with only N2 disease, who have to receive post-operativeadjuvant radiotherapy will not be eligible.
- A minimum of 3 weeks must have elapsed between the surgical interventionperformed for the NSCLC and the randomization. Adjuvant treatment must startbetween the 3rd and the 10th week from surgery.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients aged ≥ 18 years.
- PDL1 value analysed locally (hospital must be able to provide this value beforerandomization)
- PET-CT and brain CT before randomization to confirm the absence of distantdisease.
- Adequate hematologic and organ function
14.All patients are notified of the investigational nature of this study and signeda written in-formed consent in accordance with institutional and nationalguidelines, including the Declaration of Helsinki prior to any trial-relatedintervention.
15.For female patients of childbearing potential, agreement (by patient and/orpartner) to use a highly effective form(s) of contraception
- For male patients with female partners of childbearing potential, agreement (bypatient and/or partner) to use a highly effective form(s) of contraception
- Oral contraception should always be combined with an additional contraceptivemethod because of a potential interaction with the study drugs.
18.Women who are not postmenopausal or surgically sterile must have a negative serumpregnancy test result within 14 days prior to initiation of study drug.
19.Patient capable of proper therapeutic compliance and accessible for correctfollow-up
- Patients with a life expectancy of at least more than 12 weeks
Exclusion
Exclusion Criteria:
- Patients with a history of other malignant diseases, with the exception of thefollowing:
properly treated non-melanotic skin cancer
cancer in situ treated with curative intent or other malignancies treated withcurative intent and without signs of disease for a period of> 3 years after theend of the treatment and which, in the opinion of the doctor in charge of theirtreatment, do not present a substantial risk of relapse of the previousmalignant disease.
2.T4 patients with invasion of heart, great vessels, carina, trachea, oesophagus orspine
- Patients with ALK translocation, STK11 o KEAP1 known mutations before inclusionin this trial.
- Patients with adenocarcinoma NSCLC must be tested for the common EGFR mutationsbefore inclusion. Patients with any known EGFR mutation cannot be enrolled inthe study.
- Patients with a combination of microcytic and non-small cell lung cancer, acarcinoid lung tumor or large cell neuroendocrine carcinoma
- Have active chronic inflammatory bowel disease (ulcerative colitis, Crohn'sdisease) or GI perforation within 6 months of randomization.
- Patients that received live attenuated vaccines within 30 days prior torandomization
- History of a primary immunodeficiency, history of organ allogeneictransplantation, use of immunosuppressive drugs within 28 days beforerandomization or previous history of toxicity of severe immune mechanism (grade 3 or 4) with other immunological treatments
- Patients with active or uncontrolled infections or with serious medicalconditions or disorders that may not allow patient management as established inthe protocol.
- Patients who have suffered untreated and / or uncontrolled cardiovasculardisorders and / or who have symptomatic cardiac dysfunction
- Pregnant or breastfeeding women
- Patients in whom R0 resection cannot be confirmed.
- Patients with an active, known or suspected autoimmune disease. Participantswith type I diabetes mellitus, hypothyroidism only requiring hormonereplacement, skin disorders not requiring systemic treatment, or conditions notexpected to recur in the absence of an external trigger are permitted toenroll.
14.Patients with a condition requiring systemic treatment with eithercorticosteroids or other immunosuppressive medications within 14 days ofrandomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmunedisease.
- Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). In patientswith a history of HBV or HCV, patients with detectable viral loads will beexcluded.
- History of allergy or hypersensitivity to any of the study drug components
- Pleural or pericardial effusion, both will be considered indicative ofmetastatic disease unless proven otherwise. Patients with pleural effusion notvisible on chest-X-ray or too small to perform diagnostic puncture safely maybe included.
- Have known history of HIV-1 or 2 with detectable viral load OR takingmedications that may interfere with SN-38 metabolism.
19.Severe infections within 4 weeks prior to be included in the study, including butnot limited to hospitalization for complications of infection, bacteraemia, orsevere pneumonia.
20.Patients with medical, mental, neurological or psychological condition which inthe opinion of the investigator would not permit the patient to understand thepatient information sheet or comply with study procedures.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonaryillnesses including, but not limited to, any underlying pulmonary disorder; anyautoimmune, connective tissue, or inflammatory disorders with pulmonaryinvolvement; or prior pneumonectomy.
- Treatment with systemic immunosuppressive medications
23.Patients with uncontrolled comorbidities that may affect the clinical trialcompliance.
24.Sexually active men and women of childbearing potential who are not willing touse an effective contraceptive method during the study.
Study Design
Study Description
Connect with a study center
Hospital General de Elche
Elche, Alicante 03203
SpainSite Not Available
ICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona 08916
SpainSite Not Available
ICO Hospitalet
Hospitalet de Llobregat, Barcelona 08908
SpainActive - Recruiting
Hospital Universitario Jerez De La Frontera
Jerez De La Frontera, Cádiz 11407
SpainActive - Recruiting
Hospitalario Universitario A Coruña
A Coruña, La Coruña 15006
SpainActive - Recruiting
Hospital Universitari de Gran Canària Doctor Negrín
Las Palmas De Gran Canaria, Las Palmas 35010
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid 28222
SpainActive - Recruiting
Hospital de Son Espases
Palma De Mallorca, Mallorca 07120
SpainActive - Recruiting
Complejo Hospitalario Universitario de Vigo
Vigo, Pontevedra 36036
SpainActive - Recruiting
Hospital Universitari Sant Joan de Reus
Reus, Tarragona 43204
SpainActive - Recruiting
Hospital General Universitario de Alicante
Alicante, 03010
SpainActive - Recruiting
Hospital Clínic De Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hospital Parc Taulí
Barcelona, 08208
SpainActive - Recruiting
Hospital Universitari Vall d' Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital De Basurto
Bilbao, 48013
SpainActive - Recruiting
Hospital Universitario de León
León, 24071
SpainActive - Recruiting
Hospital Universitario Lucus Augusti
Lugo, 27003
SpainActive - Recruiting
Hospital Clínico San Carlos
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario la Paz
Madrid, 28046
SpainSite Not Available
Hospital Santa María Nai
Ourense, 32005
SpainActive - Recruiting
Hospital Universitari Son Llatzer
Palma De Mallorca, 07198
SpainActive - Recruiting
Hospital Universitario Salamanca
Salamanca, 37007
SpainActive - Recruiting
Hospital Universitario Nuestra Señora La Candelaria
Santa Cruz De Tenerife, 38009
SpainActive - Recruiting
Hospital Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Consorci Sanitari de Terrassa
Terrassa, 08227
SpainActive - Recruiting
Hospital Clínico de Valencia
Valencia, 46010
SpainActive - Recruiting
Hospital Universitario La Fe
Valencia, 46026
SpainActive - Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid, 47003
SpainActive - Recruiting
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