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BR31

A Phase III Prospective Double Blind Placebo Controlled Randomized Study of Adjuvant MEDI4736 in Completely Resected Non-Small Cell Lung Cancer


Complexity Level: 2

Eligibility: Completely resected primary stage IB (>= 4cm), II and IIIA non-small cell lung cancer patients (with or without adjuvant platinum based chemotherapy).

Objectives: Primary Objective: Disease free survival (DFS) for patients with NSCLC that is PD-L1 positive. Disease free survival (DFS) in all randomized patients. Secondary Objectives: Overall survival (OS) for patients with NSCLC that is PD-L1 positive, OS for all randomized patients, lung cancer specific survival for patients with NSCLC that is PD-L1 positive and all randomized patients, adverse effects and tolerability of MEDI4736, Quality of Life, survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, economic evaluation (cost effectiveness and cost utility), evaluation of predictive/prognostic significance of PD-L1 expression, evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event, exploratory pharmacogenomic assays (baseline only).

NCT Registration ID (from clinicaltrials.gov): NCT02273375
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: October 09, 2014 Closing Date: March 27, 2020

Chair: (Canada) Dr. Gail Darling, QEII Health Sciences Centre, (Italy) Dr. Francesco Perrone, Istituto Nazionale Tumori, (81) 590-3571, (Canada) Dr. Glenwood Goss, Ottawa Hospital Research Institute, (613) 737-8899 Ext. 73955, () Dr. Yi-Long Wu, Chinese Thoracic Oncology Group


Closed to Accrual
BR34

A Randomized Trial of Durvalumab and Tremelimumab +/- Platinum Based Chemotherapy in Patients with Metastatic (Stage IV) Squamous or Non-Squamous Non-Small Cell Lung Cancer (NSCLC)


Complexity Level: 2

Eligibility: - histologically and/or cytologically confirmed squamous or non-squamous NSCLC confirmed by IHC. Known EGFR mutations or ALK fusions are NOT eligible. - stage IVA or IVB per TNM version 8 staging criteria - must consent to tissue submission for PD-L1 testing. - measureable disease (RECIST 1.1) assessed within 28 days prior to randomization - 18 years of age or older - ECOG 0 or 1 - adequate hematology and biochemistry - no prior cytotoxic chemotherapy for advanced/metastatic disease - no prior EGFR, ALK inhibitors or immunotherapy

Objectives: Primary Objective To compare the overall survival (OS) of patients receiving durvalumab, tremelimumab plus platinum-based chemotherapy to that of patients receiving durvalumab and tremelimumab alone. Secondary Objectives - To compare progression free survival (PFS; RECIST 1.1) at 1 year between arms - To compare objective response rate (ORR; RECIST 1.1 and iRECIST) between arms - To compare Quality of life (QoL) between arms - To evaluate the nature, severity, and frequency of toxicities between arms. - To evaluate the incremental cost effectiveness and cost utility ratios between arms - To correlate the expression of tissue (including PD-L1) and blood markers with outcomes and response. Exploratory Objectives - To evaluate the correlation between aberrations detected using genomic cell-free DNA in blood and outcomes - Progression free survival as defined by iRECIST

NCT Registration ID (from clinicaltrials.gov): NCT03057106
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: February 15, 2017 Closing Date: November 07, 2018

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BR36 (CRI-CCTG-0002)

A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Non-Small Cell Lung Cancer

This is planned as a two stage study. Stage 1 of the study will evaluate if blood tests can be used to see how the cancer responds to treatment with pembrolizumab. Stage 2 will be finalized once stage 1 is completed with a plan to use blood tests to evaluate if patients whose cancer does not seem to be getting better on treatment with pembrolizumab would do better on a different treatment.


Complexity Level: 2

Eligibility: Eligibility: MAIN INCLUSION CRITERIA: Patients with metastatic NSCLC that is EGFR and ALK mutation negative, PD-L1 expression Tumour Proportion Score (TPS) ≥ 50% who are willing and able to receive continued pembrolizumab or addition of standard platinum-based combination therapy added to pembrolizumab after initial 6 weeks (after 2 Q3W doses or 1 Q6W dose) of pembrolizumab as systemic immunotherapy. ECOG 0-2. Clinically/radiologically evaluable disease, RECIST 1.1 measurable disease not required. Mandatory blood collection of ctDNA for screening. MAIN EXCLUSION CRITERIA: Symptomatic/unstable CNS metastases. Patients who are not suitable candidates for treatment with pembrolizumab as a single agent or in combination with standard platinum combination chemotherapy.

Objectives: Primary: Phase II progression free survival (PFS), Phase III overall survival (OS). Secondary: Phase II feasibility, RECIST response rate post randomization, safety/tolerability; Phase III RECIST response rate post randomization, response duration, progression free survival, and safety/tolerability.

NCT Registration ID (from clinicaltrials.gov): NCT04093167
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: October 17, 2019

Chair: (Canada) Dr. Sara Moore, Ottawa Hospital Research Institute, (613) 737-7700, (USA) Valsamo Anagnostou, The Sidney Kimmel Comprehensive Cancer Centre, (410) 502-3696


Open to Accrual
BR38 (BR.38)

Consolidative Use of Radiotherapy to Block (CURB2) Oligoprogression In Patients with Metastatic Non-Small-Cell Lung Cancer-A Randomized Phase 3 Trial


Complexity Level: 2

Eligibility: Participants with metatstatic, histologically confirmed non-small cell lung cancer, without an actionable driver mutataion, for whom either immune checkpoint inhibition (ICI) alone or in combination with chemotherapy is indicated. Participants must have oligoprogression on first-line ICI +/- chemotherapy after at least 3 cycles. All sites of oligopregression must be amenable to treatment with stereotactic body radiation therapy (SBRT) or ablative radiotherapy.

Objectives: 1) To evaluate if the addition of SBRT to extra-cranial oligoprogressive metastatic disease can prolong progression-free survival (PFS) and/or overall survival (OS) compared to SOC systemic therapy alone in participants with oligoprogressive NSCLC. 2) To evaluate both treatment strategies with respect to: Safety and tolerability (using CTCAE Version 5.0); Participant-reported adverse events (using PRO-CTCAE questionnaire); Participant-reported quality of life (using EORTC-QLQ-C30 and QLQ-LC13 questionnaires); Cost-effectiveness (using EQ-5D-5L questionnaire; CCTG Canadian sites only) 3) To determine biomarkers of response and resistance using peripheral blood and tissue samples.

NCT Registration ID (from clinicaltrials.gov): NCT06686771
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Chiaojung Jillian Tsai, University Health Network, (416) 946-4501


Planned
BRC5 (CALGB 140503)

A Phase III Randomized Trial of Lobectomy Versus Sublobular Resection For Small, (</= to 2cm) Peripheral Non-Small Cell Lung Cancer


Complexity Level: 1

Eligibility: Non Small Cell Lung Cancer - Stage 1

Objectives: Primary Objective: To determine whether DFS after sublobar resection (segmentectomy or wedge) is non-inferior to that after lobectomy in patients with small peripheral NSCLC. Secondary Objectives: To determine whether overall survival(after sublobar resection) is non-inferior to that after lobectomy; to determine the rates of loco-regional and systemic recurrence (exclusive of second primaries) after lobar and sublobar resection; to determine the difference between the two arms of the study in pulmonary function as determined by expiratory flow rates measured at 6 months post-operatively. Imaging Substudy: To explore the relationship between characteristics of the primary lung cancer, as revealed by pre-operative CT and PET imaging, and outcomes; a determination of the false-negative rate of the pre-operative PET scan for identification of involved hilar and mediastinal lymph nodes; and an assessment of the utility of annual follow-up CT imaging after surgical resection.

NCT Registration ID (from clinicaltrials.gov): NCT00499330
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 07, 2008 Closing Date: April 04, 2017

Chair: (Canada) Dr. Massimo Conti, University Institute of Cardiology and, (418) 656-8711


Closed to Accrual
BRC6 (SWOG S1400)

A Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer


Complexity Level: 2

Eligibility: PRE-SCREENING/SCREENING ELIGIBIILITY - patients must: (1) have pathologically proven Stage IV squamous cell lung cancer, (2) have an adequate tissue specimen as defined in the protocol and confirmed by the local pathologist, (3) not have a known EGFR mutation or ALK fusion, (4) must either be eligible to be screened at progression on prior treatment or to be pre-screened prior to progression on current treatment, (5) have Zubrod PS 0-1, (4) be > or = 18 years of age, (5) be offered participation in banking for future use of specimens (6) have previously received or currently be receiving a platinum-based chemotherapy regimen.

Objectives: (1) to establish a NCTN mechanism for genomically screening large but homogeneous cancer populations & subsequently assigning and accruing simultaneously to a multi-sub-study Master Protocol. Each of the biomarker-driven sub-studies in this protocol will evaluate a targeted therapy (TT) or targeted therapy combination (TTC) based on a designated therapeutic biomarker-drug combination, with the ultimate goal being approval of new targeted therapies in this setting. Non-match sub-studies will evaluate nonmatch therapies (NMT) in patients not eligible for any of the biomarker-driven sub-studies, also with the goal of approval (2) to evaluate the screen success rate defined as the percentage of screened patients that register for a therapeutic sub-study, (3) to establish a tissue/ blood repository from patients with refractory squamous cell cancer.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 15, 2016 Closing Date: July 12, 2018

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC6B (SWOG S1400B)

A Phase II Study of GDC-0032 (Taselisib) for Previously Treated PI3K Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


Complexity Level: 2

Eligibility: Patients must:(1) be assigned to BRC6B (i.e., defined as PI3K positive after biomarker testing),(2) have a HbAic <7% and fasting glucose < 125 mg/dL,(3) not have Type I or II diabetes that requires anti-hyperglycemic medication,(4) not have active or history of small or large intestine inflammation (eg. Crohn's disease or ulcertive colitis),(5) not require daily supplemental O2,(6) be able to take oral medications. Patients may not have any impairment or gastrointestinal function or disease that may significantly alter absorption of Taselisib-eg. ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection,(7) not be taking, or plan to take while on protocol treatment and for 14 days post last dose of study treatment, drugs, herbal supplements, or foods that are known to be strong/moderate CYP3A4 substrates,(8) be offered participation in banking for future use of specimens,(9) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to evaluate Taselisib (GDC-0032), a PI3K inhibitor, in PI3K-positive patients,(2) within Ph II component of BRC6B, to evaluate if there is sufficient evidence to continue to Ph III,(3) to evaluate investigator-assessed PFS & OS (4)to evaluate ORR,(5) to establish a tissue/blood repository from patients with refractory lung squamous cell carcinoma, (6) to evaluate DOR,(7) to evaluate frequency & severity of toxicities associated with Taselisib,(8) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to Taselisib,(9) to identify potential resistence biomarkers at PD.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 15, 2016 Closing Date: December 13, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC6C (SWOG S1400C)

A Phase II Study of Palbociclib for Previously Treated Cell Cycle Gene Alteration Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


Complexity Level: 2

Eligibility: Patients must: (1) be assigned to BRC6C (i.e., defined as Cell Cycle Gene Alteration Positive, (2) not be taking within 7 days prior to sub-study registration, nor plan to take while on protocol treatment and for 14 days after the last dose of study treatment, strong CYP3A4 inhibitors and/or strong CYP3A4 inducers, and/or drugs known to prolong the QT interval, (3) not have a screening QTcF interval > 480 msec based on the average of triplicate EKGs performed within 28 days prior to registration, (4) be able to take oral medications, (5) be offered participation in banking for future use of specimens,(6) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) within Ph II component of BRC6C, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR for cell cycle gene alteration positive patients registered to BRC6C treated with palbociclib,(2) to evaluate investigator-assessed PFS & OS cell cycle gene alteration-positive treatments with palbociclib, (3) to evaluate duration of response (DoR) among cell cycle gene alteration positive patients treated with palbociclib who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with palbociclib, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance to palbociclib, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 15, 2016 Closing Date: September 01, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC6D (SWOG S1400D)

A Phase II Study of AZD4547 for Previously Treated FGFR-Positive Patients with Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


Complexity Level: 2

Eligibility: Patients must:(1)be assigned to BRC6D (i.e., defined as FGFR positive),(2)be 25 years,(3)not be taking drugs, herbal supplements or foods that are known to be strong/moderate CYP3A4-CYP2D6 substrates,(4)not have received nitrosourea or mitomycin C within 42 D prior to sub-study registration, (5) not have had any prior exposure to any agent with FGFR inhibition as its primary pharmacology,(6)not have a mean resting QTc > 450 msec obtained from 3 consecutive ECGs,(7)not be planning to receive any concomitant medication known to prolong QT interval, (8) be able to take oral medications,(9)not have a history of hypersensitivity to active or inactive excipients of AZD4547 or with a similar chemical structure or class,(10) not have any of the listed ophthalmological criteria, (11) have an eye exam,(12)have corrected Ca and Phos < ULN,(13)have MUGA/echocardiogram,(14)be offered participation in banking for future use of specimens,(15)see also common eligibility criteria of main BRC6 trial.

Objectives: (1) within Ph II component of BRC6D, to evaluate if there is sufficient evidence to continue to Ph III by evaluating ORR with AZD4547 in FGFR-positive patients,(2) to evaluate investigator-assessed PFS & OS in FGFR-positive patients treated with AZD4547, (3) to evaluate duration of response (DoR) among FGFR positive patients treated with AZD4547 who achieve a CR or PR by RECIST 1.1, (4) to evaluate frequency & severity of toxicities associated with AZD4547 in FGFR positive patients, (5) to identify additional predictive tumour/blood biomarkers that may modify response or define resistance toAZD4547 beyond the chosen biomarker for biomarker-driven sub-studies, (6) identify potential resistance biomarkers at PD, (7) establish a tissue/ blood repository from patients with refractory squamous cell carcinoma of the lung.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 15, 2016 Closing Date: October 31, 2016

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC6F (SWOG S1400F)

A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients with Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-MAP Non-Match Sub-Study)


Complexity Level: 2

Eligibility: Patients must:(1)be assigned to BRC6F (2)have progressed during/after prior platinum-based chemo, or after anti-PD-1/anti-PD-L1 Ab monotherapy (3)no prior exposure to CTLA-4 inhibitors (ipilimumab & tremelimumab) (4)not received nitrosoureas or mitomycin-c within 42 d (5)no prior autoimmune/inflammatory disease within 3 y (6)no history of primary immunodeficiency (7)no immunosuppressive meds within 28 d. Systemic corticosteroids stopped at least 24 h (8) no Gr 3 or worse irAE (9)no organ transplant that requires immunosuppressives (10)no allergy/reaction to Durvalumab &/or tremelimumab (11)no active tuberculosis infection (12)no live attenuated vaccination within 28 d (13)no known HIV, or + test for Hep B virus surface antigen (HBV sAg), or Hep C virus ribonucleic acid (HCV Ab) indicating current acute/chronic infection (14)have TSH with reflex T3/T4 free (if TSH is out of normal range) & ECG within 7 d (15)specimen banking (16)see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to evaluate ORR (confirmed & unconfirmed, CR & PR) by RECIST 1.1 among patients treated with Durvalumab + Tremelimumab (2) to estimate DoR among patients who achieve a CR or PR (confirmed and unconfirmed) by RECIST 1.1 (3) to estimate the DoR per immune-related response criteria for patients who achieve a CR or PR (confirmed & unconfirmed) by RECIST 1.1 (4) to evaluate OS for patients treated with Durvalumab + Tremelimumab (5) to evaluate IA-PFS for patients treated with Durvalumab + Tremelimumab (6) to evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) for patients treated with Durvalumab + Tremelimumab (7) to evaluate the frequency & severity of toxicities associated with Durvalumab + Tremelimumab (8) to explore the association of potential predictive markers identified in BRC6A, with response & PFS (9) to explore the association of PD-L1 expression status with response & PFS (10) to contribute to an ongoing BRC6 serum & tumor bank.

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 27, 2018 Closing Date: July 12, 2018

Closed to Accrual
BRC6G (SWOG S1400G)

A Phase II Study of Talazoparib (BMN 673) in Patients with Homologous Recombination Repair Deficiency Positive Stage IV Squamous Cell Lung Cancer (Lung-Map Sub-Study)


Complexity Level: 2

Eligibility: Patients must: (1) be assigned to BRC6G (i.e., defined as HRRD positive),(2) not have prior exposure to any agent with a PARP inhibitor,(3) have achieved SD, a PR, or a CR at their first assessment after initiating first-line platinum-based chemotherapy, (4) not have any impairment of GI function or GI disease that may significantly alter absorption of talazoparib, (5) be able to take oral medications, (6) not be taking, nor plan to take while on protocol treatment strong P-gp inhibitors, P-gp inducers, or BCRP inhibitors, (7) agree to have blood specimens submitted for PK analysis, (8) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to evaluate the overall response rate (ORR) (confirmed and unconfirmed, complete and partial) with talazoparib in HRRD MDVN-positive patients, (2) to evaluate investigator- assessed PFS (IA-PFS) & OS associated with therapy in HRRD MDVN-positive patients, (3) to evaluate ORR, IA-PFS, and OS in HRRD FMI-positive patients, (4) to evaluate ORR in HRRD MDVN-negative/ HRRD FMI-positive patients, (5) to evaluate the frequency and severity of toxicities associated with talazoparib in HRRD FMI-positive patients, (6) to assess if the HRD score is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (7) to assess if the level of PARP protein expression determined by immunohistochemistry is associated with clinical outcomes (response, PFS, OS) in HRRD FMI-positive patients treated with talazoparib, (8) to characterize pharmacokinetic properties of talazoparib.

NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 20, 2017 Closing Date: July 12, 2018

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC6I (SWOG S1400I)

A Phase III Randomized Study of Nivolumab plus Ipilimumab versus Nivolumab for Previously Treated Patients with Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)


Complexity Level: 2

Eligibility: Patients must (1)be assigned to BRC6I, (2) not had prior treatment with an anti-PD-1, anti-PDL1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways,(3) not have an active, known, or suspected autoimmune disease,(4) not have any known allergy or reaction to any component of the nivolumab & ipilimumab formulations,(5) not have received systemic treatment with corticosteroids or other immunosuppressive medications within 14 D,(6)not have a known + test for HBV sAg or HCV antibody indicating acute or chronic infection,(7) not have known history of testing positive for HIV or known AIDS,(8) not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity,(9) must also be offered participation in banking for future use of specimens,(10) see also common eligibility criteria of main BRC6 trial.

Objectives: (1) to compare OS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab, (2) to compare investigator-assessed PFS in patients with advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab vs nivolumab,(3) to compare the response rates (confirmed and unconfirmed, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab,(4) to compare the response rates (confirmed only, complete and partial) per RECIST 1.1 among patients randomized to receive nivolumab plus ipilimumab vs nivolumab, (5) to evaluate the frequency and severity of toxicities associated with nivolumab plus ipilimumab vs nivolumab, (6) to evaluate if there is an differential treatment effect on OS, IA-PFS, and Response by tumor PD-L1 expression status.

NCT Registration ID (from clinicaltrials.gov): NCT02154490
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: April 15, 2016 Closing Date: April 23, 2018

Chair: (Canada) Dr. Natasha Leighl, University Health Network, (416) 946-4645


Closed to Accrual
BRC7 (ECOG-ACRIN EA5163)

INSIGNA: A Randomized, Phase III Study of Firstline Immunotherapy alone or in Combination with Chemotherapy in Induction/Maintenance or Post Progression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature-driven Analysis


Complexity Level: 2

Eligibility: Patients must have histologically or cytologically confirmed stage IV non-squamous NSCLC (includes M1a, M1b, and M1c stage disease. Patients with T4NX disease (Stage IIIB) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation. Patients must have PD-L1 expression Tumor Proportion Score (TPS)greater than or equal to 1% in tumor cells. Patients must have measurable or non-measureable disease.

Objectives: Co-primary objective is to evaluate overall survival (OS) in each of the 2 experimental arms (Arms A and B) to control (Arm C). To evaluate progression-free survival (PFS) for Arm C versus each of Arms A and B; best objective response rates for Arm C versus each of Arms A and B; to estimate toxicity within each of the treatment arms via the CTCAE criteria, compare outcomes b/w Arms A & B, and outcomes by treatment arm within subgroups defined by a cutpoint of PD-L1 expression at > 50%.

NCT Registration ID (from clinicaltrials.gov): NCT03793179
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: July 10, 2019 Closing Date: March 01, 2024

Chair: (Canada) Dr. Andrew Robinson, Cancer Centre of Southeastern Ontario at Kingston, (613) 549-6666 Ext. 8104


Closed to Accrual
BRC8 (SWOG S1827)

MRI Brain Surveillance Alone versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK)

Patients with Small Cell Lung Cancer can have disease that is confined to the chest (limited disease) or spread further (extensive disease). In both situations the initial treatment is chemotherapy, which very often substantially reduces the amount of disease present. Patients with limited disease are also treated with radiotherapy to the chest as are some patients with extensive disease. Unfortunately, even though chemotherapy and radiotherapy are usually successful in initially controlling SCLC, many patients with this disease eventually develop spread of the disease to the brain (brain metastases). Because of this, it is usual practice to administer brain irradiation to patients whose disease has responded to its initial treatment. This treatment does reduce the frequency of brain metastases, but radiation to the brain can impair thinking processes and it is not certain that giving radiation increases how long patients live. An alternative to administering radiation to all patients before they develop evidence of having spread of SCLC to the brain is to follow patients closely with regular imaging studies (Magnetic Resonance Imaging - MRIs) and to treat only those patients who develop brain metastases. Using this approach would mean that many patients would not suffer from loss of thinking function. The purpose of this study is to find out whether this latter approach can be substituted for the regular use of radiotherapy without affecting how long patients live


Complexity Level: 2

Eligibility: Disease Related Criteria: a) Patient must have a histologically confirmed diagnosis of small-cell lung cancer(SCLC). b) Patient must have an MRI of the brain performed within 28 days prior to registration documenting no evidence of brain metastases or leptomeningeal disease. Patient also must not have a history of brain metastases or leptomeningeal disease. Prior/Concurrent Therapy Criteria: a) Immunotherapy concurrent with and/or adjuvant to first-line therapy is allowed at the discretion of the treating pysician. b) All adverse events from prior treatment must have resolved to Grade 2 (CTCAE Version 5.0) prior to randomization. c) Patient must have had a response to first-line therapy and no evidence of progression in opinion of the treating investigator. d) No more then 8 weeks elapsed between D1 of last cycle of chemotherapy and radomization e) Patient must not have received prior radiotherapy to the brain or WBRT.

Objectives: Primary Objective: To evaluate whether overall survival (OS) with MRI surveillance alone is not inferior to MRI surveillance combined with prophylactic cranial irradiation (PCI) for the treatment of small cell lung cancer (SCLC). Secondary Objectives: To compare cognitive failure free survival (CFFS) rate up to 12 months after randomization between the arms. To compare brain-metastasis-free survival between the arms. To compare OS between the arms within the subgroups of patients with limited-stage and extensive-stage disease. To compare cognitive failure free survival (CFFS) rates at the assessment times between the arms. To compare the cumulative incidence of cognitive failure with death as a competing risk between the arms. To compare the frequency and severity of toxicities between the two arms. Additional Objectives: To collect blood for banking.

NCT Registration ID (from clinicaltrials.gov): NCT04155034
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: May 27, 2020

Chair: (Canada) Dr. Jonathan Greenland, Dr. H. Bliss Murphy Cancer Centre, (709) 777-7802


Open to Accrual
I227

A Phase II/III Randomized Study of Pembrolizumab in Patients with Advanced Malignant Pleural Mesothelioma


Complexity Level: 2

Eligibility: Patients must have histologically confirmed unresectable advanced and/or metastatic malignant pleural mesothelioma with available tumour block. No prior chemotherapy for advanced/metastatic disease. Prior (neo) adjuvant cisplatin-based systemic chemotherapy allowed if last dose > 12 months before registration. No prior targeted small molecule therapy, immunotherapies and viral therapies, biologic therapies and angiogenesis inhibitors for advanced/metastatic disease, or any prior immunotherapy for any stage of disease. Prior radiation therapy is permitted (< 30% BM), measurable disease outside the previously irradiated area is required. No diagnosis of immunodeficiency or is receiving systemic steroid therapy (doses > 10 mg prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to first dose of trial treatment. No active autoimmune disease requiring systemic treatment < 3 years. No live attenuated vaccines within 30 days.

Objectives: rimary - To evaluate whether pembrolizumab, alone or given to patients receiving standard chemotherapy, improves progression free survival in malignant pleural mesothelioma (MPM) compared to standard chemotherapy. Secondary To evaluate whether pembrolizumab improves overall survival when added to standard chemotherapy; To evaluate the tolerability of pembrolizumab, alone or given to patients receiving standard chemotherapy; To assess antitumour activity of pembrolizumab, alone or given to patients receiving standard chemotherapy including response rate and overall survival; To evaluate quality of life effects of pembrolizumab, alone or given to patients receiving standard chemotherapy. Exploratory - To explore the predictive and prognostic value of PD-L1 expression and presence of T cell subsets within the tumour microenvironment and other exploratory blood based biomarkers.

NCT Registration ID (from clinicaltrials.gov): NCT02784171
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Permanently Closed
Activation Date: October 07, 2016 Closing Date: September 04, 2020

Chair: (Canada) Dr. Quincy Chu, Cross Cancer Institute, (780) 432-8248, (Italy) Dr. Francesco Perrone, Istituto Nazionale Tumori, (81) 590-3571


Permanently Closed
I242

Neoadjuvant Platform Trial in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC)


Complexity Level: 1

Eligibility: Histologically confirmed diagnosis of primary NSCLC within 90 days of enrollment to a substudy, according to WHO/ classified as Stage IA2 to IIIA according to the AJCC 8th edition TNM classification with disease that is amenable to anatomical surgical resection. Patients with multistation N2.; must be ≥ 18 years of age. No prior anticancer therapy for treatment of NSCLC. Patients with a history of NSCLC treated in the curative setting may be eligible but must be discussed with CCTG prior to enrollment, ECOG performance status of 0 or 1; synchronous primary tumours may be eligible if all of the following conditions are met:, surgery must be performed between 2 to 4 weeks following the last dose of neoadjuvant therapy, adequate organ and marrow function.

Objectives: To identify promising neoadjuvant treatment regimens for NSCLC for later validation in randomized clinical trials, by evaluating major pathological response rates (MPR). Secondary, to summarize the safety and tolerability of each regimen and to evaluate other indicators of activity such as: Overall response rate (ORR) using RECIST 1.1 (and other criteria such as iRECIST as applicable) for neoadjuvant treatment period; Complete pathological response (cPR) rate; Event-free survival rate at 2 years; and Surgical outcomes, including completeness of surgical resection, extent and access to surgery, extent of perihilar/lobar fibrosis or mediastinal adhesions and tumour downstaging. Exploratory include: To identify potential predictive biomarkers of response and mechanisms of resistance, and explore patient related outcomes (PRO).

NCT Registration ID (from clinicaltrials.gov): NCT05714891
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: May 26, 2023 Closing Date: December 16, 2024

Chair: (Canada) Dr. Normand Blais, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444, (Canada) Dr. Jonathan Spicer, The Research Institute of the McGill University, (514) 934-1934 Ext. 43050


Closed to Accrual
I242A

A Phase II Pre-operative Trial of JDQ433 in Patients with Surgically Resectable Non-Small Cell Lung Cancer (NSCLC)


Complexity Level: 1

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Closed to Accrual
Activation Date: May 26, 2023 Closing Date: May 08, 2024

Chair: (Canada) Dr. Jonathan Spicer, The Research Institute of the McGill University, (514) 934-1934 Ext. 43050, (Canada) Dr. Normand Blais, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8444


Closed to Accrual