This is an open-label, phase II, multi-centre clinical trial. 97 Patients with stage IIIA and IIIB non-small cell lung cancer will be enrolled. The treatment is Atezolizumab + Paclitaxel + Carboplatin 3 cycles as neoadjuvant/induction treatment. After the induction treatment every patient will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not. Depending on the decision each patient will be treated in a different way. The primary objective is to evaluate the Progression free survival (PFS). The total trial duration will be 10 years approximately. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and 4-6 months of close-out.
The study ATHENEA is a phase II clinical trial intending to enroll 97 patients, who will receive Atezolizumab + Paclitaxel + Carboplatin as induction/neoadjuvant treatment. After the induction treatment all patients will be evaluated by a multidisciplinary team in each participant hospital to decide if the patient is candidate for surgery or not. Depending on the decision each patient will be treated in a different way. The study is an open-label, phase II, multicenter clinical trial for previously untreated adult patients with stage to IIIA and IIIB non-small cell lung cancer. The primary objective is to evaluate the Progression free survival (PFS) in the intent-to-treat population. Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death. The total trial duration will be 10 years approximately. Approval-start up: 4-6 months. Patient accrual is expected to be completed within 2 years. Two years of treatment, 5 years of follow up, and close-out: 4-6 months. The study will end once survival follow-up has concluded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
97
Patients will receive atezolizumab administered by intravenous infusion in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
Neoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Paclitaxel: Intravenous infusion. Guidelines of 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.
Neoadjuvant / induction treatment: Atezolizumab Paclitaxel Carboplatin\* \*Infusion according to the standard of each center Neoadjuvant / induction treatment 3 cycles will be administered prior to the assessment for surgery. Route of administration Carboplatin: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center.
Hospital General Universitario Dr. Balmis de Alicante
Alicante, Alicante, Spain
RECRUITINGICO Badalona, Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
RECRUITINGHospital Universitari Vall d' Hebron
Barcelona, Barcelona, Spain
RECRUITINGHospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGHospital Parc Taulí
Barcelona, Barcelona, Spain
RECRUITINGHospital De Basurto
Bilbao, Bilbao, Spain
RECRUITINGHospital Univ. De Jerez De La Frontera
Jerez de la Frontera, Cadiz, Spain
RECRUITINGICO Girona, Hospital Josep Trueta
Girona, Girona, Spain
RECRUITINGHospital Universitario Clinico San Cecilio
Granada, Granada, Spain
RECRUITINGHospitalario Universitario A Coruña
A Coruña, La Coruña, Spain
RECRUITING...and 11 more locations
Progression-free survival (PFS)
Progression free survival (PFS) defined as the time from initiation of treatment to the occurrence of disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time frame: From the date of randomization until end of follow up, up to 60 months.
Resectability rate (%)
Resectability rate defined as the percentage of patients resected divided by the total number of patients who received neoadjuvant treatment.
Time frame: From the date of randomization until end of follow up, up to 60 months.
Pathological complete response (pCR)
Pathological complete response (pCR) is defined as the absence of residual viable tumor on hematoxylin and eosin evaluation of the complete resected specimen
Time frame: From the date of randomization until end of surgery, up to 6 months
Overall survival (OS)
Overall survival (OS) defined as the time which begins at the start of treatment and up to the time of death or last follow up
Time frame: From the date of randomization until end of follow up, up to 60 months.
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