IMpower030/GO40241: A Phase III, Double-Blinded, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Neoadjuvant Treatment With Atezolizumab or Placebo in Combination With Platinum-Based Chemotherapy in Patients With Resectable Stage II, IIIA, or Select IIIB Non−Small Cell Lung Cancer
Indication :

Cancer du poumon (NSCLC)


Sponsor :

Hoffmann-La Roche


Phase :

III


Ligne :

Perioperative (neoadjuvant and adjuvant)


Traitement :

Atezolizumab or Placebo in combination with platinum-based chemotherapy


Site :

CHUV


Contact(s) :
Prof. Solange Peters

CHUV

Rue du Bugnon 46
Lausanne
1011

+41213144462
solange.peters@chuv.ch

Primary objective :

Evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (MPDL3280A) or placebo in combination with platinum-based chemotherapy in patients with resectable Stage II, IIIA, or select IIIB non−small cell lung cancer (NSCLC) followed by open-label adjuvant atezolizumab or best supportive care and monitoring.


Inclusion criteria :

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Histologically or cytologically confirmed, resectable Stage II, IIIA, or Select IIIB - T3N2 only - NSCLC of squamous or non-squamous histology . Staging should be based on the 8e edition of the AJCC-UICC staging system.
Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent
Adequate pulmonary and cardiac function to undergo surgical resection
Measurable disease defined by RECIST v1.1
Adequate hematologic and end organ function
Negative HIV test at screening
Negative for active HBV and HCV at screening


Exclusion criteria :

Any prior therapy for lung cancer
Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated expected curative outcome
Non-squamous NSCLC histology with activating ALK and EGFR mutation
Pregnant or lactating women
History of autoimmune disease
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or evidence of active of active pneumonitis on screening chest Computed Tomography (CT) scan
Prior treatment with cluster of differentiation 137 (CD137) agonist or immune checkpoint blockade therapies, anti-programmed-death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibody
Severe infection within 4 weeks prior to randomization
Significant history of cardiovascular disease