Second Line Trials

1. Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer

      ClinicalTrials.gov Identifier:             NCT02323126      

This study has been terminated. 

A Phase II, Multicenter, Open-label Study of EGF816 in Combination With Nivolumab in Adult Patients With EGFR Mutated Non-small Cell Lung Cancer and of INC280 in Combination With Nivolumab in Adult Patients With cMet Positive Non-small Cell Lung Cancer
 
Ontario
Toronto

2. A Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen (CheckMate 153)

      ClinicalTrials.gov Identifier:             NCT02066636      

This study has been completed.  
 
A Phase IIIb/IV Safety Trial of Nivolumab (BMS-936558) in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Progressed During or After Receiving At Least One Prior Systemic Regimen.

Quebec
Local Institution
Levis, Quebec, Canada, G6V 3Z1
 
 

3. Study to Compare AMG 510 "Proposed INN Sotorasib" with Docetaxel in NSCLC (CodeBreak 200)
 
      ClinicalTrials.gov Identifier:             NCT04303780      

This study is active but not currently recruiting. 

A Phase 3 Study to Compare AMG 510 with Docetaxel in Non Small Cell Lung Cancer (NSCLC) subjects with KRAS p. G12c mutation

Ontario 
Hamilton
Ottawa
London
Toronto
 

4. Pembrolizumab With Nab-Paclitaxel in Non-Small Cell Lung Cancer (URCOH-PMS-001)

      ClinicalTrials.gov Identifier:             NCT02733250      

This study has been completed.  
 
The purpose of this study is to determine the optimal dose of nab-paclitaxel to be safely administered in combination with pembrolizumab in patients with advanced inoperable non-small cell lung cancer. The study is also aimed at evaluating the efficacy of the combination therapy.

Quebec
Centre hospitalier de l'université de Montréal (CHUM) - Notre-Dame Hospital
Montreal, H2L 4M1
 
Jewish General Hospital
Montreal,  H3T 1E2

5. Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

      ClinicalTrials.gov Identifier:             NCT02785952      

This study is active but not currently recruiting. 

This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumours. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.

Ontario
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9

Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
 
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4

6. Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously
Treated c-Met+ Non-Small Cell Lung
 Cancer

      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 / ID# 204540                          Recruiting
Edmonton, Alberta, Canada, T6G 1Z2

Ontario
The Ottawa Hospital / ID# 205579                            Recruiting 
Ottawa, Ontario, Canada, K1H 8L6 

Princess Margaret Cancer Centre / ID# 204423        Recruiting 
Toronto, Ontario, Canada, M5G 2M9 

Quebec 
CISSS de la Monteregie / ID# 211356                       Recruiting 
Greenfield Park, Quebec, Canada, J4V 2H1 

7. Phase II Umbrella Study of Novel Anti-cancer Agents in Patients With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy. (HUDSON)

      ClinicalTrials.gov Identifier:             NCT03334617      

This study is currently recruiting participants.

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                                                    Recruiting
Edmonton, Alberta, Canada, T6G 1Z2

Ontario
Research Site                                                    Recruiting                       
Brampton, Ontario, Canada, L2P 2V3               

Research Site                                                    Recruiting
Ottawa, Ontario, Canada, K1H 8L6                   

Research Site                                                    Recruiting        
Toronto, Ontario, Canada, M5G 2M9 
             
Quebec
Research Site                                                    Recruiting
Montreal, Quebec, Canada, H2X 3E4 

 8. Phase III Study Evaluating Efficacy and Safety of Canakinumab in Combination With Docetaxel in Adult Subjects With Non-small Cell Lung Cancers as a Second or Third Line Therapy (CANOPY-2)

      ClinicalTrials.gov Identifier:             NCT03626545      

This study has been completed. 

This phase III study is designed to evaluate the role of IL-1β inhibition in combination with docetaxel in subjects with advanced NSCLC previously treated with PD-(L)1 inhibitors and platinum-based chemotherapy. The randomized III part will be preceded by a safety run-in part in which the recommended dose of the combination of canakinumab and docetaxel will be confirmed.

British Columbia 
Norvartis Investigative Site                                             
Vancouver, British Columbia, Canada, V5Z 4E6 
 

9. Phase 2 Study of Tarloxotinib in Patients With NSCLC Harboring EGFR Exon 20 Insertion or HER2-activating Mutations (RAIN)

      ClinicalTrials.gov Identifier:              NCT03805841      

The recruitment for this study has been terminated (enrollment pause). 

A Phase 2 Study to Evaluate the Objective Response to Tarloxotinib Administered Intravenously to Patients With Non Small Cell Lung Cancer That Harbors Either EGFR Exon 20 Insertion or a HER2-Activating Mutation.

Ontario
Potential RAIN-701 Study Site                                                
Toronto, Ontario, Canada, M5G 2C1 
 

10. Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

      ClinicalTrials.gov Identifier:              NCT04185883      
 
This study is currently recruiting participants.
 
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors

Quebec
Laval
 
 

11. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

      ClinicalTrials.gov Identifier:              NCT04606381      
 
This study is currently recruiting participants.
 
The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.

Ontario
Ottawa
Toronto
 

12. Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

      ClinicalTrials.gov Identifier:              NCT03645928      
 
This study is currently recruiting participants.
 
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.

Ontario
Toronto
 

13. Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study

      ClinicalTrials.gov Identifier:              NCT04589845    
 
This study is currently recruiting participants.
 
TAPISTRY is a Phase II, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in rational, specified combinations in participants with unresectable, locally advanced or metastatic solid tumors determined to harbor specific oncogenic genomic alterations or who are tumor mutational burden (TMB)-high as identified by a validated next-generation sequencing (NGS) assay. Participants with solid tumors will be treated with a drug or drug regimen tailored to their NGS assay results at screening. Participants will be assigned to the appropriate cohort based on their genetic alteration(s). Treatment will be assigned on the basis of relevant oncogenotype, will have cohort-specific inclusion/exclusion criteria, and, unless otherwise specified, will continue until disease progression, loss of clinical benefit, unacceptable toxicity, participant or physician decision to discontinue, or death, whichever occurs first.

British Colombia
Vancouver

Ontario
London
Ottawa
Toronto

Quebec
Montreal
 

14. Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

      ClinicalTrials.gov Identifier:              NCT03907852     
 
This study is currently recruiting participants.
 

Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex.

This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.


Ontario
Toronto
 

15Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)

      ClinicalTrials.gov Identifier:              NCT04656652      
 
This study is currently recruiting participants.
 
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus docetaxel in participants with previously treated advanced or metastatic non-small cell lung cancer (NSCLC) with or without actionable genomic alterations.

Alberta
Edmonton

Ontario
Toronto
UHN

Toronto
Sunnybrook

Quebec
Montreal
 

16. A Study to Assess the Safety and Efficacy of AZD7789 in
Participants With Advanced or Metastatic Solid Cancer

      ClinicalTrials.gov Identifier:              NCT04931654     
 
This study is currently recruiting participants.
 
This is a Phase I/IIa study designed to evaluate if experimental anti-PD-1 and anti-TIM-3 bispecific antibody, AZD7789 is safe, tolerable and efficacious in participants with advanced solid tumors.

Ontario
Toronto
 

17. Osimertinib Then Chemotherapy in EGFR-mutated Lung Cancer With Osimertinib Third-line Rechallenge (OCELOT)

      ClinicalTrials.gov Identifier:              NCT04335292     
 
This study is currently recruiting participants.
 

This phase II single-armed study will examine the clinical utility of retreating patients with osimertinib, in the third-line, following first-line treatment with osimertinib and second-line treatment with platinum and pemetrexed chemotherapy. The current standard of care for first-line Epidermal Growth Factor Receptor (EGFR) mutated Advanced Non-Small Cell Lung Cancer (aNSCLC) is osimertinib, followed by cytotoxic chemotherapy.

The repeat of osimertinib following previous treatment failure is investigational, although supported by scientific rationale. The dosing and scheduling of osimertinib follows its use in approved settings. The investigators examine its tolerability and efficacy in this setting to ensure osimertinib is a safe third-line option for patients with Epidermal Growth Factor Receptor mutated (EGFR+) Advanced Non-Small Cell Lung Cancer(aNSCLC).


British Colombia
Vancouver

Ontario
Brampton
Hamilton
Kitchener
London
Oshawa
Ottawa 
Toronto
 

18. A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies

      ClinicalTrials.gov Identifier:              NCT04606381    
 
This study is currently recruiting participants.
 
The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.

Ontario
Ottawa
Toronto
 

19. 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
 

20. APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met DysregulatioAdvanced Solid Tumors (SPARTA)

      ClinicalTrials.gov Identifier:             NCT03175224     

This study is currently active and recruiting participants
 

The primary Phase 1 purpose of this study was to assess overall safety, tolerability and recommended Phase 2 dose (RP2D) of APL-101.

The Phase 2 portion will assess efficacy of the dose determined in Phase 1 in individuals with Non-Small Cell Lung Cancer with c-Met EXON 14 Skip Mutations; individuals with cancers associated with c-Met amplifications; individuals with cancers associated with c-Met fusion


Alberta
Edmonton
Manitoba
Winnipeg
Ontario
Toronto
Quebec
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. 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
 

15. 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
 

16. 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
 

16. Talazoparib and Thoracic RT for ES-SCLC

      ClinicalTrials.gov Identifier:             NCT04170946    

This study is currently active and recruiting participants
 

This is a phase I, dose escalating study evaluating the safety of combining talazoparib and low dose consolidative thoracic radiotherapy for small cell lung cancer patients. This study will also determine the maximum tolerated dose (MTD) of talazoparib in combination with low dose thoracic radiotherapy.

Patients will start on talazoparib on day 1 of study intervention, and will continue to orally take talazoparib until the last day of radiation therapy. Up to 24 patients will be enrolled to the study, where the first 3 patients will start with a starting dose level of talazoparib is 0.5 mg PO once daily. This will increase to 1mg daily with each new cohort.


Ontario
Toronto
 

16. Safety and Efficacy Study of Pembrolizumab (MK-3475) in Combination With Investigational Agents for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)

      ClinicalTrials.gov Identifier:             NCT04938817   

This study is currently active and recruiting participants
 

This study is a rolling arm study of pembrolizumab in combination with investigational agents in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation.

Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D.

There will be no hypothesis testing in this study.


Alberta
Edmonton

Ontario
Toronto

Quebec
Montreal