Second Line Trials and beyond NSCLC

Clinical Study of Ivonescimab for First-line Treatment of Metastatic Squamous NSCLC Patients
 

        ClinicalTrials.gov Identifier:                 NCT05899608   
 

This study is currently recruiting participants.

This is a Phase 3 Randomized, Controlled, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer. The primary endpoint is overall survival and key secondary endpoints include progression free survival. response and safety.


Ontario
University Health Network, Toronto


Study of Oral MRT-2359 in Selected Cancer Patients
 

        ClinicalTrials.gov Identifier:                 NCT05546268      


This study is currently recruiting participants.
 

This Phase 1/2, open-label, multicenter study is conducted in patients with previously treated selected solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), high-grade neuroendocrine cancer of any primary site, diffuse large B-cell lymphoma (DLBCL), and tumors with L-MYC or N-MYC amplification. Patients receive escalating doses of a GSPT1 molecular glue degrader MRT-2359 to determine safety, tolerability, maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of MRT-2359. Once the MTD and/or RP2D is identified, additional patients enroll to Phase 2 study, which includes molecular biomarkers stratification or selection, namely expression or amplification of L-MYC and N-MYC genes, hormone receptor positive (HR)-positive, human epidermal growth factor 2 (HER2)-negative breast cancer and prostate cancer.

Alberta
Edmonton, Cross Cancer Institute

Ontario
Toronto, Princess Margaret Hospital

 

 

A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/​- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies

        ClinicalTrials.gov Identifier:                 NCT03847649    
 

This study is currently recruiting participants.

 
I238A: The purpose of this study is to find out what effects being treated with durvalumab has on cancer. The researchers doing this study also want to evaluate if prednisone (a type of steroid), when given together with durvalumab, can reduce any side effects. 
I238B: The purpose of this study is to allow patients previously enrolled on a completed CCTG trial to continue treatment with durvalumab (+/- tremelimumab)
 
Alberta
Edmonton
Cross Cancer Institute
Contact: Quincy Chu 780 432-8248
 
British Columbia
Kelowna
BCCA - Cancer Centre for the Southern Interior
Contact: Sara Kristina Taylor 250 712-3996
 
Vancouver
BCCA - Vancouver Cancer Centre
Contact: Christian Kollmannsberger 604 877-6000 ext 2734
 
New Brunswick
Saint John
Regional Health Authority B, Zone 2
Contact: Anthony J. Reiman 506 648-6884
 
Ontario
Hamilton
Juravinski Cancer Centre at Hamilton Health Sciences
Contact: Peter Ellis 905 387-9495
 
Kitchener
Grand River Regional Cancer Centre
Contact: Stacey Hubay 519 749-4370 ext 5262
 
Ottawa
Ottawa Hospital Research Institute
Contact: Scott Laurie 613 737-7700 ext 70173
 
Toronto
University Health Network
Contact: Penelope A. Bradbury 416 946-4501 ext 3544
 
Windsor
Windsor Regional Cancer Centre
Contact: Swati Kulkarni 519 253-5353
 
Quebec
Montreal
CHUM-Centre Hospitalier de l'Universite de Montreal
Contact: Normand Blais 514 890-8444
 
Quebec City
CHU de Quebec-Hopital l'Enfant-Jesus (HEJ)
Contact: Andre Blais 418 682-7511

Saskatchewan
Saskatoon
Saskatoon Cancer Centre
Contact: Nayyer Iqbal 306 655-2710


First in Human Study of AZD9592 in Solid Tumors (EGRET)

        ClinicalTrials.gov Identifier:                 NCT05647122   
 

This study is currently recruiting participants.

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.

Alberta
Edmonton
 
Ontario
Toronto
 

AMG 193, Methylthioadenosine (MTA) Cooperative Protein Arginine Methyltransferase 5 (PRMT5) Inhibitor, Alone and in Combination With Docetaxel in Advanced Methylthioadenosine Phosphorylase (MTAP)-Null Solid Tumors (MTAP)

      ClinicalTrials.gov Identifier:            NCT05094336    
 
This study is currently recruiting participants.
 
The primary objective of Parts 1 and 2 of this study is to evaluate the safety, tolerability, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of AMG 193 alone and in combination with docetaxel in adult participants with metastatic or locally advanced methylthioadenosine phosphorylase (MTAP)-null solid tumors.
 
The primary objective of Part 3 of this study is to evaluate the objective response rate (ORR) of AMG 193 in adult participants with metastatic or locally advanced MTAP-null solid tumors

Alberta
Cross Cancer Institute, Edmonton

Ontario
Princess Margaret Cancer Centre, Toronto

A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer (PACIFIC-9)

      ClinicalTrials.gov Identifier:          NCT05221840    


This study is currently recruiting participants. 

This is a Phase III, randomised, double-blind, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) in combination with oleclumab (MEDI9447) or durvalumab (MEDI4736) with monalizumab (IPH2201) in adults with locally advanced (Stage III), unresectable NSCLC, who have not progressed following platinum-based cCRT.

Alberta
Edmonton
 
Ontario
Hamilton
Kingston
London
Toronto

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

      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
University Health Network, Toronto

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
      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

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
        ClinicalTrials.gov Identifier:                  NCT04563338    
 
This study is currently recruiting participants.
 

This study is being done to look at how effective the drug, atezolizumab, with or without the drug bevacizumab, is for people with inoperable liver cancer or non-small lung cancer that has spread to the liver. This will be done by looking at the duration of time from starting the study drug(s) until the cancer worsens in study participants.

This study will collect blood and tumor tissue samples from participants to look at changes to their tumor(s) before and after receiving atezolizumab and/or bevacizumab.


Ontario
Princess Margaret Cancer Centre, Toronto

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

      ClinicalTrials.gov Identifier:           NCT04931654    
 
This study is currently active and recruiting participants

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448.

Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Quincy Chu      
 
Ontario
Brampton, Ontario, Canada, L6R 3J7
Principal Investigator: Parneet Cheema        

Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Adrian Sacher
      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
 

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

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
Princess Margaret Cancer Centre, Toronto
 

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
 

Platform Trial of Novel Regimens Versus Standard of Care (SoC) in Participants With Non-small Cell Lung Cancer (NSCLC)

      ClinicalTrials.gov Identifier:           NCT04931654    

This study is currently active and recruiting participants

This study will compare the clinical activity of novel regimens (in combination or as single agents) to SoC in participants with relapsed/refractory advanced NSCLC. The study will be conducted in two parts. Part 1 is an open-label, optional, non-randomized part based on safety and pharmacokinetics/pharmacodynamics (PK/PD) evaluation intended to generate additional data to qualify novel regimens for the randomized study. Part 2 is a randomized, Phase II open-label part comparing the efficacy and safety of these novel regimens with SoC. Drug name mentioned as GSK4428859A and EOS884448 are interchangeable for the same compound and will be referred to as GSK4428859A/EOS884448.

Alberta
Edmonton, Alberta, Canada, T6G 1Z2
Principal Investigator: Quincy Chu      
 
Ontario
Brampton, Ontario, Canada, L6R 3J7
Principal Investigator: Parneet Cheema        

Toronto, Ontario, Canada, M5G 2M9
Principal Investigator: Adrian Sacher
      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)
 

 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 active but not 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 Edmonton

Ontario
Research Site Brampton
Research Site Ottawa
Research Site Toronto

Quebec
Research Site Montreal

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 active but not 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
 
      ClinicalTrials.gov Identifier:              NCT04656652      
 
This study is active but not currently recruiting. 
 
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
University Health Network, Toronto

Sunnybrtook Health Sciences Centre, Toronto

Quebec
Montreal

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

Saskatchewan
Allan Blair Cancer Centre, Regina
Saskatoon Cancer Centre, Saskatoon

 


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 active but not currently recruiting. 

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
Edmonton

Ontario
Brampton
Ottawa        
Toronto 
             
Quebec
Montreal 
 

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 active but not 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