Neo-Adjuvant Trials

1. Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy (ALMERA) 

         ClinicalTrials.gov Identifier:                     NCT02115464           

ALMERA is a randomized, phase II, open label study in patients with locally advanced non-small cell lung cancer (NSCLC) which will compare standard radiotherapy plus concurrent chemotherapy versus the same treatment plus concurrent Metformin continuing for 12 months. Metformin is a well tolerated and inexpensive drug that has the potential to improve cancer patient outcomes. 

Ontario 
Juravinski Cancer Centre, Hamilton
Grand River Regional Cancer Centre, Kitchener
Walker Family Cancer Centre - Niagara Health System, St. Catharines 
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston

Quebec
Montreal General Hospital, Montreal 

Manitoba
Health Sciences Center, Winnipeg 

Alberta
Cross Cancer Institute, Edmonton 

2. Phase II Lung Metcore - Preoperative Metformin for Lung Cancer (Metcore)

         ClinicalTrials.gov Identifier:                    NCT03086733          

This is a phase II single centre open label single arm pre-operative window of metformin treatment in stage I-IIIa Non-small cell lung cancer. In which patients will be invited to participate by receiving Metformin treatment during 14 to 21 days at 850 mg BID until the day before surgery. 

Ontario 
Princess Margaret Hospital, Toronto 
Toronto General Hospital, Toronto 

3. Efficacy and Safety of 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)

       ClinicalTrials.gov Identifier:             NCT03425643      
 
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). 

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

Quebec
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
 

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

           ClinicalTrials.gov 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.

Quebec
Jonathan Spicer                                    Not yet recruiting 
Montreal, Quebec, Canada, H4 3J1

Contact: Jonathan Spicer, MD   
514-934-1934
jonathan.spicer@mcgill.ca

Contact: Penny Chipman
514-934-1934
penny.chipman@muhc.mcgill.ca 

Principal Investigator: Johnathan Spicer, MD

5. 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)

         ClinicalTrials.gov 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. 

Quebec
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

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

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

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

           ClinicalTrials.gov 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