Third Line Trials

1. Study of Crizotinib for ROS1 and MET Activated Lung Cancer

      ClinicalTrials.gov Identifier:             NCT04084717      

This study is currently active and recruiting participants
 
This is a phase 2 study of a drug called crizotinib in people with metastatic (the cancer has spread to other parts of the body) non-small cell lung cancer with a mutation (change) in genes called ROS1 or MET. The purpose of this study is to look at how effective crizotinib is at treating ROS1 or MET mutated non-small cell lung cancer.

Crizotinib, also called XALKORI, is a chemotherapy drug that is currently approved for the treatment of ALK- or ROS1- positive advanced non-small cell lung cancer.

Ontario
Princes Margaret Hospital, Toronto

2. BMS-986012 in Relapsed/Refractory SCLC

      ClinicalTrials.gov Identifier:             NCT02247349      

This study is currently active but not recruiting participants

The purpose of this study is to determine the safety, tolerability, pharmacokinetics,immunogenicity,antitumor activity and pharmacodynamics of BMS-986012 in subjects with relapsed/refractory SCLC.

Alberta
Cross Cancer Institute, Edmonton

Ontario
Princess Margaret Hospital, Toronto 
 

3. Study of Safety and Efficacy of Ceritinib in Combination With Nivolumab in Patients With ALK-positive Non-small Cell Lung Cancer

      ClinicalTrials.gov Identifier:             NCT02393625      

This study is currently active but not recruiting participants

This is an open label multi center trial to determine the safety and efficacy of ceritinib in combination with nivolumab in ALK-positive NSCLC patients.

Ontario 
Toronto, Ontario, M5G 2M9 
 

4. Sapanisertib and Osimertinib in Treating Patients With Stage IV EGFR Mutation Positive Non-small Cell Lung Cancer After Progression on a Previous EGFR Tyrosine Kinase Inhibitor

      ClinicalTrials.gov Identifier:              NCT02503722      
 
This study is currently active but not recruiting participants
 
This phase I trial studies the side effects and best dose of sapanisertib when given together with osimertinib in treating patients with stage IV EGFR mutation positive non-small cell lung cancer that has progressed after treatment with an EGFR tyrosine kinase inhibitor. Sapanisertib and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
 
British Columbia
BCCA-Vancouver Cancer Centre  
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Site Public Contact, 888-939-3333      
Principal Investigator: Cheryl Ho   
     
Ontario
University Health Network-Princess Margaret Hospital  
Toronto, Ontario, Canada, M5G 2M9
Contact: Site Public Contact, 416-946-4501   clinical.trials@uhn.on.ca   
Principal Investigator: Penelope A. Bradbury     


5. Clinical Study of Oral cMET Inhibitor INC280 in Adult Patients With EGFR Wild-type Advanced Non-small Cell Lung Cancer (Geometry Mono-1)

      ClinicalTrials.gov Identifier:              NCT02414139      

This study is currently active but not recruiting participants

A phase II study to evaluate antitumor activity of oral cMET inhibitor INC280 in adult patients with EGFR wild-type, advanced non-small cell lung cancer (NSCLC).

Ontario 
Novartis Investigative Site
Ottawa, Ontario,  K1H 8L6

6. Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Preciously Treated c-MET+ NSCLC

       ClinicalTrials.gov Identifier:              NCT03539536      
 
This study is currently recruiting participants

This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that over express c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2).

Alberta
Cross Cancer Institute, Edmonton

Ontario
Ottawa Hospital, Ottawa
Princess Margaret Hospital, Toronto

Quebec
CISSS de la Monteregie, Greenfield Park

7. Efficacy and Safety of Pembrolizumab (MK-3475) with Levatinib (E7080/MK-7902) vs, Docetaxel in Particpants with Metastatic NSCLC and Progressive Disease (PD) after Platinum Doublet Chemotherapy and Immunotherapy (MK-7902-008/E7080-G000-316/LEAP-008)

      ClinicalTrials.gov Identifier:              NCT03976375      
 
This study is currently active but not recruiting participants
 
This study will evaluate the efficacy and safety of pembrolizumab (MK-3475) with lenvatinib (E7080/MK-7902) vs. docetaxel in participants with metastatic non-small cell lung cancer (NSCLC) and progressive disease (PD) after platinum doublet chemotherapy and treatment with one prior anti-PD-1/PD-L1 monoclonal antibody (mAb).
 
Manitoba
CancerCare Manitoba (Site 1504)

Ontario 
Kingston Health Sciences Centre (Site 1503)
London Regional Cancer Program - London HSC (Site 1505)
Princess Margaret Cancer Centre - Toronto (Site 1502)

Quebec
CIUSSS Ouest de l'Ile - St Mary's Hospital - Montreal (Site 1501)
CHU de Quebec - Universite Laval - Hotel Dieu de Quebec (Site 1514)
 

8. An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive Non-Small-Cell Lung Cancer Participants Who Have Progressed on Crizotinib (ALTA-3)

      ClinicalTrials.gov Identifier:             NCT03596866      
 
This study is currently recruiting participants

The purpose of this study is to compare the efficacy of brigatinib versus alectinib in participants with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small-cell lung cancer (NSCLC) who have progressed on crizotinib as evidenced by progression free survival as assessed by a blinded independent review committee (BIRC) utilizing response evaluation criteria in solid tumors (RECIST) v1.1.

Nova Scotia 
Queen Elizabeth II Health Sciences Centre            
Halifax, Nova Scotia, Canada, B3H 1V7 
 
 
Ontario
Toronto University Health Network  
Toronto, Ontario, Canada, M5G 2M9

 

9. Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC (COAST)

      ClinicalTrials.gov Identifier:             NCT03822351      

This study is currently active but not recruiting participants

The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents. The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
 
Alberta
Research Site  
Edmonton, Alberta, Canada, T6G 1Z2
 
Ontario
Research Site  
Toronto, Ontario, Canada, M5G 2M9


10. A Study of Brigatinib in Participants With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non-Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib (ALTA-2)

      ClinicalTrials.gov Identifier:              NCT03535740      

This study is currently active but not recruiting participants

The primary purpose of this study is to determine the efficacy of brigatinib by confirmed objective response rate (ORR) by response evaluation criteria in solid tumors (Response Evaluation Criteria in Solid Tumors [RECIST]), in participants with ALK+ locally advanced or metastatic NSCLC whose disease has progressed on therapy with alectinib or ceritinib.
 
Alberta
Cross Cancer Institute  
Edmonton, Alberta, Canada, T6G 1Z2
 
Tom Baker Cancer Center  
Calgary, Alberta, Canada, T2N 2T9
 
Ontario
Toronto University Health Network  
Toronto, Ontario, Canada, M5G 2M9
 
Quebec
McGill University Health Centre                         
Montreal, Quebec, Canada, H4A 3J1
 

11. Phase II Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Non-small Cell Lung Cancer (NSCLC)

 
      ClinicalTrials.gov Identifier:              NCT03739710      

This study is currently recruiting participants
 
This study will compare the clinical activity of novel immune-oncology agents (in combination or as single agents) to standard of care in participants with relapsed/refractory advanced NSCLC. The study will initially evaluate two treatment regimens/arms. Additional regimens/arms may be added via future protocol amendment(s). Participants will be stratified by histology (squamous vs. non-squamous) and line of anti-programmed cell death ligand 1 (PD[L]1) therapy (first vs. second line). Initially, the study will evaluate the GSK3359609 inducible T-cell co-stimulator (ICOS) agonist in combination with SoC docetaxel compared to docetaxel alone (sub-study 1). SoC arm will be the common comparison arm across all sub-studies. At study start, subjects will be randomized to the study at a ratio of 1:2 to Arm 1 (docetaxel) and Arm 2 (ICOS agonist + docetaxel). The study will consist of three periods: Screening, Treatment, and Follow-Up. There will be approximately 105 participants enrolled in the study initially. Treatment will continue for approximately 2 years and participants will be followed for survival during the follow-up period.
 
Alberta
GSK Investigational Site                                                                           
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Quincy Chu         
 
Ontario
GSK Investigational Site                                                                         
Brampton, Ontario, Canada, L6R 3J7
Principal Investigator: Parneet Cheema   
     
GSK Investigational Site                                                                           
Ottawa, Ontario, Canada, K1H 8L6
Principal Investigator: Paul Wheatley-Price   
     
GSK Investigational Site                                                                          
Toronto, Ontario, Canada, M5G 2M9
 
     ClinicalTrials.gov Identifier:            NCT03334617     

This study is currently recruiting patients
 
This is an open-label, multi-centre, umbrella Phase II study in patients with metastatic NSCLC who have progressed on an anti-PD-1/PD-L1 containing therapy. This study is modular in design, allowing initial assessment of the efficacy, safety, and tolerability of multiple treatment arms.

Alberta   
Research Site Edmonton

Ontario
Research Site Brampton
Research Site Ottawa
Research Site Toronto

Quebec
Research Site Montreal

13. Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung cancer (CHRYSALIS)

     ClinicalTrials.gov Identifier:            NCT02609776   

This study is currently recruiting participants
The purpose of study is to evaluate the safety, pharmacokinetics, and preliminary efficacy of Amivantamab as a monotherapy and in combination with lazertinib, and to determine the recommended Phase 2 dose (RP2D) (monotherapy), recommended Phase 2 combination dose (RP2CD) (combination therapy), and to determine recommended Phase 2 Dose (RP2q3W) with combination chemotherapy (Amivantamab in combination with standard of care carboplatin and pemetrexed) in 21 day treatment cycle for participants with advanced non-small cell lung cancer (NSCLC).

British Columbia 
Vancouver

Ontario
University Health Network, Toronto
 

14. SAR408701 Versus Docetaxel in Previously Treated, Carcinoembryonic Antigen-related Cell Adhesion Molecule 5 (CEACAM5) Positive Metastatic Non-squamous Non-small Cell Lung cancer Patients (CARMEN-LC03)

   ClinicalTrials.gov Identifier:            NCT04154956   

This study is currently recruiting participants
 
The primary objective is to determine whether SAR408701 improves the progression free survival (PFS) when compared to docetaxel in participants with metastatic non-squamous NSCLC expressing CEACAM5 ≥2+ in intensity in at least 50% of the tumor cell population and previously treated with standard-of-care platinum-based chemotherapy and an immune checkpoint inhibitor (ICI).

Quebec
Greenfield Park, Montreal

15. Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer (SAPPHIRE)

  ClinicalTrials.gov Identifier:            NCT03906071   

This study is currently recruiting participants
 
his study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.

Ontario

Princess Margaret Hospital Toronto

16. An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small-Cell Lung Cancer (NSCLC) Participants Who Have Progressed on Crizotinib (ALTA-3)

  ClinicalTrials.gov Identifier:            NCT03596866   

This study is currently recruiting participants
 
The purpose of this study is to compare the efficacy of brigatinib versus alectinib in participants with ALK+ locally advanced or metastatic NSCLC who have progressed on crizotinib as evidenced by progression-free survival (PFS) as assessed by response evaluation criteria in solid tumors (RECIST) v1.1.

Nova Scotia
Queen Elizabeth II Health Sciences Centre, Halifax

Ontario
University Health Network, Toronto

17. Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC

  ClinicalTrials.gov Identifier:            NCT03333343   

This study is currently active but not recruiting participants. 
 
The study purpose is to evaluate the safety, tolerability, and preliminary efficacy of the addition of INC280, trametinib, ribociclib, gefitinib, or LXH254 to EGF816 in adult patients with advanced EGFR-mutant NSCLC.

Ontario
Toronto

18. Phase 2 Study of Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation

  ClinicalTrials.gov Identifier:            NCT03318939   

This study is currently recruiting participants
 
This is a Phase 2, open-label, multi-center study to evaluate the efficacy and the safety/tolerability of poziotinib in seven patient cohorts for up to 603 previously treated and treatment-naïve NSCLC patients.

Alberta
Cross Cancer Institute, Edmonton

Ontario
London Regional Cancer Program, London
Princess Margaret Hospital, Toronto

British Columbia
BC Cancer, Vancouver
 
        ClinicalTrials.gov Identifier:                  NCT03709706      
 
This study is currently active but not recruiting participants
 
 The primary objective of the study is to evaluate the safety and tolerability of autologous genetically modified T-cells (GSK3377794) in human leukocyte antigen (HLA) positive participants with NY-ES0-1/ LAGE-1a positive advanced non-small cell lung cancer (NSCLC) alone (Arm A) or GSK3377794 in combination with pembrolizumab in participants with NSCLC with wildtype epidermal growth factor receptor (WT EGFR) and WT anaplastic lymphoma kinase/ c-ros oncogene 1 (ALK/ROS1) (Arm B) and participants with NSCLC with EGFR or ALK/ROS1 aberration (Arm C). This study consists of screening phase, Leukapheresis/ GSK3377794 manufacture, lymphodepletion/treatment phase and follow-up. Participants will receive GSK3377794 as monotherapy (Arm A); or as a combination therapy with pembrolizumab (Arm B), and participants in Arm C will receive the same treatment as participants in the Arm B. Approximately 54 participants will be enrolled into the study.

Ontario
Toronto

Quebec
Montreal
 

30.TAC T-cells for the Treatment of HER2-positive Solid Tumors (TACTIC-2)

      ClinicalTrials.gov Identifier:             NCT04727151      

This study is currently active and recruiting participants
 

TAC01-HER2 is a novel cell therapy that consists of genetically engineered autologous T cells expressing T-cell Antigen Coupler (TAC) that recognizes human epidermal growth factor receptor 2 (HER2). TAC directs T-cells to the targeted antigen (HER2), and once engaged with the target, activates them via the endogenous T cell receptor.

This is an open-label, multicenter Phase 1/2 study that aims to establish safety, Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D), pharmacokinetic profile and efficacy of TAC01-HER2 in subjects with relapsed or refractory solid tumors.


Ontario
Princes Margaret Hospital, Toronto
 

31. A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

      ClinicalTrials.gov Identifier:             NCT03093116    

This study is currently active and recruiting participants
 

Phase 1 dose escalation will determine the first cycle dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), the biologically effective dose and recommended Phase 2 dose (RP2D) of repotrectinib given to adult subjects with advanced solid malignancies harboring an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.

Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.

Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.



Alberta
Edmonton

British Colombia
Vancouver

Ontario
Brampton
Ottawa
Toronto

 
32. A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

      ClinicalTrials.gov Identifier:             NCT02912949    

This study is currently active and recruiting participants
 

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)


Ontario
Toronto
 

 
33. A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation

      ClinicalTrials.gov Identifier:             NCT04449874   

This study is currently active and recruiting participants
 

This is a Phase I dose-escalation and dose-expansion study that will evaluate the safety, pharmacokinetics (PK), and preliminary activity of GDC-6036 in patients with advanced or metastatic solid tumors with a KRAS G12C mutation.


Ontario
Ottawa
Toronto

Quebec
Montreal