Neo-Adjuvant Trials

1. Efficacy and Safety Pembrolizumab (MK-3475) With Platinum Doublet Chemotherapy as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (MK-3475-671/KEYNOTE-671) Identifier:             NCT03425643      

This study is currently recruiting participants.

This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage IIB or IIIA non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by blinded central pathologist or by imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by blinded independent central review (BICR); and 2) overall survival (OS). 

Princess Margaret Cancer Centre (Site 0109)                          Recruiting
Toronto, Ontario, Canada, M5G 2M9 
Contact: Study Coordinator 416-946-4501 x 3809 

CIUSSS du Saguenay-Lac-St-Jean (Site 0101)                         Recruiting 
Chicoutimi, Quebec, Canada, G7H 5H6 
Contact: Study Coordinator 418-541-1234 x 2840 

CIUSSS Ouest de l'ile-St-Mary's Hospital (Site 0104)              Recruiting 
Montreal, Quebec, Canada, H3T 1M5
Contact: Study Coordinator 514-345-3511

2. Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC (NA_00092076) 

  Identifier:                      NCT02259621            

This study is currently recruiting participants.

The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.

Jonathan Spicer                                                                         
Montreal, Quebec, Canada, H4 3J1


3. A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC) (CheckMate 816)
 Identifier:                  NCT02998528        

This study is active but not currently recruiting.

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. 

CISSS de l'Outaouais (Site 0095)                                    
Gatineau, Quebec, 

McGill University Health Center (Site 0017)                    
Montreal, Quebec

Local Institution
St. Jerome

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du- Quebec (Site 0052)        Trois-Rivieres, Quebec

Saskatoon Cancer Centre (Site 0016)                              
Saskatoon, Saskatchewan, Canada, S7N 4H4

Local Institution (Site 0138)                                                            
Montreal, Canada, H2X 0A9

4. Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

  Identifier:                       NCT03794544         

This study is currently active, but not recruiting participants.  

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in subjects with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC). 

Research Site
Montreal, Quebec, Canada, H3A 0G4 

5. A Study of Neoadjuvant/Adjuvantr Durvalumab for the Treatment of Patients with Resectable NCLC

  Identifier:                    NCT 03800134       

This study is currently recruiting participants. 

This is a Phase III, randomized, double-blind placebo-controlled, multi-centre international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of major pathalogical response.





6. A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

  Identifier:                   NCT04025879        

This study is currently recruiting participants.

The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer.

Greenfield Park