This study is being done to answer the following question: What are the effects of new treatments on non-small cell lung cancer before surgery?
The purpose of the pre-study screening is to test for biomarkers. The testing will be done using a sample of your tumor tissue. Each substudy will be looking at what effects a new drug has on the patients and their lung cancer, as well as any side effects of the treatment. The purpose of each substudy is to see if the biomarkers that were identified at screening can be used to determine treatment outcomes, like how the cancer cells respond to treatment and whether the study drug will shrink the tumour before surgery and prevent it from returning after surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Dose will be assigned at enrollment
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Kingston Health Sciences Centre
Kingston, Ontario, Canada
London Health Sciences Centre Research Inc.
London, Ontario, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
Identify promising neoadjuvant treatment regimens for NSCLC for later validation in randomized clinical trials, by evaluating major pathological response rates (MPR)
Time frame: 3 years
Number and severity of adverse events as per CTCAE version 5.0
Time frame: 3 years
Overall response rate using RECIST 1.1
Time frame: 3 years
Pathological complete response rate (pCR)
Time frame: 3 years
Event-free survival at 2 years
Time frame: 3 years
Completeness of surgical resection using the Residual (R) Tumor Classification
Time frame: 3 years
Access to surgery (rate of open, video-assisted and robotic-assisted thoracic surgery)
Time frame: 3 years
Rate (and reasons) of surgical access conversion (from video-assisted or robotic-assisted thoracic surgery to open surgery)
Time frame: 3 years
Extent of surgery (rate of surgery types: wedge resection, segmentectomy, lobectomy, completion lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, major airway resection, and other)
Time frame: 3 years
Extent of perihilar/lobar fibrosis and mediastinal adhesions (as per the Lee et al. (JTO, 2021) grading scale)
Time frame: 3 years
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University Health Network
Toronto, Ontario, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
The Research Institute of the McGill University
Montreal, Quebec, Canada
University Institute of Cardiology and
Québec, Quebec, Canada
Tumour downstaging: rate of patients with post-surgical downstaging when comparing cTNM and pTNM
Time frame: 3 years