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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundación GECP

About this trial

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.

Eligibility criteria

Qualifiers

Previously untreated patients with histologically- or cytologically- documented Non Small-Cell Lung Cancer (NSCLC) who present stage IIIA - IIIB disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology)

Confirm the absence of distant disease

ECOG (Performance status) 0-1

Adequate hematologic and organ function

Disqualifiers

Patients mutation or an amplification in the EGFRgene, ALK fusion oncogene.

Known STK-11 ligand alterations, MDM2 amplifications or ROS1 translocations.

Weight loss >10% within the previous 3 months.

Patients that receive previous treatment with antineoplasic drugs, chest radiotherapy, or previous surgery for lung cancer.

Trial design

Treatments tested in this trial

  • Atezolizumab
  • Paclitaxel
  • Carboplatin

Treatment groups

97 Participants
are divided into 1 treatment group

Sponsors and collaborators