NCT07153445

Neoadjuvant Treatment With Atezolizumab and Atezolizumab as Maintenance for the Treatment of Stage III Non Small-Cell Lung Cancer (NSCLC)

Phase II Clinical Trial of Chemotherapy + Atezolizumab for Stage IIIa and IIIb Non-small Cell Lung Cancer Followed by Atezolizumab as Adjuvant Treatment After Surgery and Atezolizumab as Maintenance Treatment for Non-resected Patients After Chemoradiotherapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Fundación GECP · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Non Small Cell Lung Cancer
• Stage IIIA Lung Cancer
• Stage IIIB Lung Cancer

Interventions

Type	Name	Description
DRUG	Atezolizumab	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.
DRUG	Paclitaxel	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.
DRUG	Carboplatin	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.

Timeline

• Start date: 2025-07-08
• Primary completion: 2035-05-02
• Completion: 2035-05-02
• First posted: 2025-09-04
• Last updated: 2025-11-19

Locations

21 sites across 1 country: Spain