A Phase III, Double-blind, Randomised, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Participants with EGFR mutation-positive Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumour Resection (ADAURA2)
Primary Objective: This is a global study to assess the effects of osimertinib in participants with EGFR mutation-positive stage IA2-IA3 non-small cell lung cancer following complete tumour resection.
Primary Investigator: Altorki, Nasser M.D.
Contact: Julissa Murillo, jum2040@med.cornell.edu (212) 746-4528
ClinicalTrials.gov Identifier: NCT05120349
Status: Active
Patient Accrual: Open to Patient Accrual
Durvalumab (MEDI4736) With or Without SBRT in Clinical Stage I, II and IIIa Non-small Cell Lung Cancer
Primary Objective: The purpose of this study is to find out the effectiveness of the drug durvalumab (MEDI4736) with or without stereotactic body radiation therapy (SBRT) as treatment for stage I (tumors > 2cm), II, and IIIA non-small cell lung cancer (NSCLC) prior to surgery and one year following surgery.
Principal Investigator: Nasser Altorki, MD
Contact: Cathy Spinelli, R.N. caf2007@med.cornell.edu (212) 746-3328
ClinicalTrials.gov Identifier: NCT02904954
Status: Active
Patient Accrual: Closed to Patient Accrual
Esophageal Cancer
Multicenter, Randomized Phase II study of Pembrolizumab in combination with chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma
Primary Objective: This study will test the safety and efficacy of the combination of pembrolizumab with chemotherapy and chemoradiation in locally advanced esophageal adenocarcinoma. Eligible patients will be randomized to either Cohort 1 or Cohort 2. Patients in Cohort 1 will receive induction chemotherapy followed by chemo radiation while patients in Cohort 2 will receive induction chemotherapy plus pembrolizumab followed by chemoradiation. Patients in both cohorts will then go on to have a resection followed by pembrolizumab. The treatment phase will last up to approximately 14 weeks and the post-surgery phase will last up to approximately 12 months. It is expected that patients will be randomized over approximately 18 months.
Primary Investigator: Altorki, Nasser M.D.
Contact: Cathy Spinelli, R.N. caf2007@med.cornell.edu (212) 746-3328
Protocol ID: WCMC IRB # 1602016966
Status: Active
Patient Accrual: Closed to Patient Accrual
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Primary Objective: This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.
Principal Investigator: Nasser Altorki, MD
Contact:Cathy Spinelli, R.N. caf2007@med.cornell.edu (212) 746-3328
ClinicalTrials.gov Identifier: NCT02486718
Status: Active
Patient Accrual: Closed to Patient Accrual
Non-Small Cell Lung Cancer
A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (< 2cm) Peripheral Non-Small Cell Lung Cancer (CALGB 140503).
Primary Objective: This randomized trial is studying different types of surgery to compare how well they work in treating patients with stage IA non-small cell lung cancer.
Sublobar resection (wedge resection or segmentectomy) may be less invasive types of surgery than lobectomy for non-small cell lung cancer and may have fewer side effects and improve recovery. It is not yet known whether wedge resection or segmentectomy are more effective than lobectomy in treating stage IA non-small cell lung cancer.
Patients will be randomized to receive a Lobectomy or a Sublobar Resection. After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 5 years.
Primary Investigator: Altorki, Nasser M.D.
Contact: Cathy Spinelli, R.N. caf2007@med.cornell.edu (212) 746-3328
Protocol ID: WCMC IRB #0709009395
Status: Active
Patient Accrual: Closed to Patient Accrual