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
Centre Hospitalier de l Universite de Montreal                      Recruiting
- CHUM ( Site 0110)
Montreal, Quebec, Canada, H2X 0C1
Contact: Study Coordinator 514-890-8000 

McGill University Health Centre (Site 0111)                            Recruiting 
Montreal, Quebec, Canada, H4A 3J1 
Contact: Study Coordinator 514-934-1934 x36675

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

  Identifier:                      NCT02259621            
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                                    Not yet recruiting 
Montreal, Quebec, Canada, H4 3J1

Contact: Jonathan Spicer, MD   

Contact: Penny Chipman

Principal Investigator: Johnathan Spicer, MD

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        

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)                                    Recruiting
Gatineau, Quebec, Canada, J8P 7H2
Contact: Shelly Sud, 819-966-6130 x 8134

McGill University Health Center (Site 0017)                   Recruiting  
Montreal, Quebec, Canada, H4A 3J1
Contact: Jonathan Spicer, 514-934-1934 x 45748

Local Institution                                                              Withdrawn 
St. Jerome, Quebec, Canada, J7Z 5T3

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-Centre-du- Quebec (Site 0052)                                Recruiting
Trois-Rivieres, Quebec, Canada, G8Z 3R9 
Contact: Jean-Sebastien Aucoin, 819-693-3333 x 63238

Saskatoon Cancer Centre (Site 0016)                             Recruiting 
Saskatoon, Saskatchewan, Canada, S7N 4H4
Contact: Sunil Yadav, 306-655-2640

Local Institution                                                             Recruiting 
Montreal, Canada, H2X 0A9
Contact: Site 0138 

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

  Identifier:                       NCT0379544         
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). 

Canada, Quebec
Research Site                                                      Not yet recruiting 
Montreal, Quebec, Canada, H3A 0G4