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

Conditions

Early-Stage Resectable Non-small cell lung cancer (NSCLC)

Brief summary

IRF-assessed EFS

Detailed description

1. IRF-assessed pCR, 2. IRF-assessed MPR, 3. MPR and pCR, as assessed by the investigator site pathology laboratory, 4. Objective response by the investigator according to RECIST v1.1, 5. OS, 6. Investigator-assessed EFS, 7. DFS as determined by the investigator, 8. 2-year and 3-year OS, IRF assessed EFS and investigator-assessed EFS, 9. Change from baseline in health-related quality of life (HRQoL) scores as assessed through use of the two-item global health status (GHS)/ QoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow up assessments, 10. Occurrence and severity of adverse events, including serious adverse events and immune-related adverse events, with severity determined according to NCI CTCAE v5.0, 11. Incidence and length of surgical delays, incidence of operative and post-operative complications, and/or reasons for surgical cancellations, 12. Serum concentration of atezolizumab at specified timepoints, 13. Incidence of anti-drug antibodies (ADAs) against atezolizumab during the study

Related papers

No related papers found yet.

Interventions

DRUGTecentriq Placebo

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGTecentriq 1 200 mg concentrate for solution for infusion

DRUGALIMTA 500 mg powder for concentrate for solution for infusion

DRUGGemcitabine 38 mg/ml Concentrate for Solution for Infusion

DRUGCarboplatin 10 mg/ml Intravenous Infusion

DRUGCisplatin 1mg/ml concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
IRF-assessed EFS	—

Secondary

Measure	Time frame
1. IRF-assessed pCR, 2. IRF-assessed MPR, 3. MPR and pCR, as assessed by the investigator site pathology laboratory, 4. Objective response by the investigator according to RECIST v1.1, 5. OS, 6. Investigator-assessed EFS, 7. DFS as determined by the investigator, 8. 2-year and 3-year OS, IRF assessed EFS and investigator-assessed EFS, 9. Change from baseline in health-related quality of life (HRQoL) scores as assessed through use of the two-item global health status (GHS)/ QoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow up assessments, 10. Occurrence and severity of adverse events, including serious adverse events and immune-related adverse events, with severity determined according to NCI CTCAE v5.0, 11. Incidence and length of surgical delays, incidence of operative and post-operat	—

Measure

Time frame

1. IRF-assessed pCR, 2. IRF-assessed MPR, 3. MPR and pCR, as assessed by the investigator site pathology laboratory, 4. Objective response by the investigator according to RECIST v1.1, 5. OS, 6. Investigator-assessed EFS, 7. DFS as determined by the investigator, 8. 2-year and 3-year OS, IRF assessed EFS and investigator-assessed EFS, 9. Change from baseline in health-related quality of life (HRQoL) scores as assessed through use of the two-item global health status (GHS)/ QoL subscale (Questions 29 and 30) of the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 at each assessment time point during the study through the completion of adjuvant treatment and observation follow up assessments, 10. Occurrence and severity of adverse events, including serious adverse events and immune-related adverse events, with severity determined according to NCI CTCAE v5.0, 11. Incidence and length of surgical delays, incidence of operative and post-operat

—

Countries

Austria, France, Germany, Italy, Poland, Slovenia, Spain, Sweden

Outcome results

None listed