Trial Title:
Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer
NCT ID:
NCT05714891
Condition:
NSCLC
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JDQ443
Description:
Dose will be assigned at enrollment
Arm group label:
Neoadjuvant therapy (JDQ443) followed by surgery. (ARM CLOSED)
Summary:
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?
Detailed description:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histologically confirmed diagnosis of primary NSCLC within 90 days of enrollment to
a substudy, according to WHO Classification of Tumours
- Unless otherwise specified in a substudy, patients must be classified as Stage IA2
to IIIA according to the AJCC 8th edition TNM classification with disease that is
amenable to anatomical surgical resection.
- Pre-surgical staging of patients with newly diagnosed lung cancer should include: CT
thorax, abdomen and pelvis; PET scan imaging; Brain MRI or CT brain with IV
contrast. Patients with mediastinal lymph nodes suspicious for metastases on PET
imaging are required to undergo invasive staging by EBUS or mediastinoscopy to
confirm or disprove pathological involvement of suspected nodes.
- All patients must have evaluable disease as defined by RECIST 1.1 although
measurable disease is recommended.
- Patients that are eligible for one or more substudies must consent for release of
tissue biopsies, surgical specimens and blood samples for conduct of tissue
analyses. If there is insufficient tissue to conduct the proposed research studies
without exhausting the diagnostic biopsies, please consult CCTG
- Patients 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
- Patient must have an ECOG performance status of 0 or 1
- Patients with synchronous primary tumours may be eligible if all of the following
conditions are met:
- The synchronous tumour is located within the planned resection area
- The radiological appearance of the tumour is compatible with ground-glass
opacity (GGO)
- The synchronous tumour is not FDG-avid on PET imaging
- The local multidisciplinary thoracic oncology tumour board has approved the
surgical treatment plan
- Surgery for participants enrolled on this protocol will be according to generally
accepted standards of care. Operative approach (VATS, RATS vs open) will be
determined by the surgeon. Accepted types of resection must aim to achieve an R0
resection, as defined by the IASLC, including the highest resected mediastinal being
negative for carcinoma.
- Unless otherwise specified in specific substudies, surgery must be performed between
2 to 4 weeks following the last dose of neoadjuvant therapy
- Patients must have adequate organ and marrow function within 7 days prior to
enrollment. Some substudies may require different cutoff values.
- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements.
- Patient is able and willing to complete the Patient Related Outcomes questionnaire
- Patients must be accessible for treatment and follow-up.
- Protocol treatment is to begin within 2 working days of patient enrollment
- Women/men of childbearing potential must have agreed to use a highly effective
contraceptive method
Exclusion Criteria:
- Presence of locally advanced, unresectable cancer (regardless of stage), or
metastatic cancer (Stage IV).
- Patients with a history of other malignancy may be eligible if curatively treated
and/or the malignancy does not affect the determination of safety or efficacy of the
investigational regimen (must be confirmed with CCTG).
- Clinically significant, uncontrolled cardiac disease and/or recent cardiac events
(within 6 months), such as:
- Unstable angina or myocardial infarction within 6 months prior to enrollment;
- Symptomatic congestive heart failure (defined as New York Heart Association
Grade II or greater);,
- Documented cardiomyopathy;,
- Clinically significant cardiac arrhythmias; (Note: patients with clinically
controlled, asymptomatic atrial arrhythmias without any ventricular function
compromise may be eligible; please consult CCTG).
- Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mm
Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, unless controlled prior
to first dose of study treatment.
- Patients with a significant cardiac history, even if controlled, should have
LVEF ≥ 50%
- History or current diagnosis of ECG abnormalities indicating significant risk of
safety for participants participating in the study such as:
- Concomitant clinically significant cardiac arrhythmias e.g. sustained
ventricular tachycardia, and clinically significant second or third-degree AV
block without a pacemaker;
- History of familial long QT syndrome or known family history of Torsades de
Pointes;
- Resting QT interval corrected with Fridericia's formula (QTcF) > 480 msec on
screening ECG or congenital long QT syndrome.
- Patients with prior allogenic bone marrow transplant, double umbilical cord blood
transplantation (dUCBT) or solid organ transplant.
- Patients with active or uncontrolled infections or with serious illnesses or medical
conditions which would not permit the patient to be managed according to the
protocol. This includes but is not limited to:
- Known clinical diagnosis of tuberculosis;
- Pneumonitis or any history of pneumonitis requiring steroids (any dose);
- Known primary immunodeficiency;
- For Hepatitis B (HBV), Hepatitis C (HCV) and human immunodeficiency virus (HIV)
infections, requirements will be substudy dependent.
- History of hypersensitivity to any drugs in any substudy, or to drugs of similar
chemical class.
- Concurrent treatment with other investigational drugs or anti-cancer therapy.
- Pregnant or breastfeeding women.
- Patients who are unable to swallow oral medication and/or have impairment of
gastrointestinal (GI) function or GI disease that may significantly alter the
absorption of the specific substudy drug(s)
- Patients with a history of non-compliance to medical regimens.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Quincy Chu
Phone:
780 432-8248
Facility:
Name:
BCCA - Vancouver
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Barbara Lynn Melosky
Phone:
604 877-6000
Phone ext:
2017
Facility:
Name:
CancerCare Manitoba
Address:
City:
Winnipeg
Zip:
R3E 0V9
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Shantanu Banerji
Phone:
204 787-8959
Facility:
Name:
Kingston Health Sciences Centre
Address:
City:
Kingston
Zip:
K7L 2V7
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Andrew Robinson
Phone:
613 549-6666
Phone ext:
8104
Facility:
Name:
Verspeeten Family Cancer Centre
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Daniel Breadner
Phone:
519 685-8600
Facility:
Name:
Ottawa Hospital Research Institute
Address:
City:
Ottawa
Zip:
K1H 8L6
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Sara Moore
Phone:
613 737-7700
Facility:
Name:
University Health Network
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Penelope A. Bradbury
Phone:
416 946-4501
Phone ext:
3544
Facility:
Name:
CHUM-Centre Hospitalier de l'Universite de Montreal
Address:
City:
Montreal
Zip:
H2X 3E4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Normand Blais
Phone:
514 890-8444
Facility:
Name:
The Research Institute of the McGill University
Address:
City:
Montreal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Scott Owen
Phone:
514 398-8307
Facility:
Name:
University Institute of Cardiology and
Address:
City:
Quebec City
Zip:
G1V 4G5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Catherine Labbe
Phone:
418 656-8711
Phone ext:
5504
Start date:
September 15, 2023
Completion date:
March 31, 2028
Lead sponsor:
Agency:
Canadian Cancer Trials Group
Agency class:
Other
Collaborator:
Agency:
Novartis
Agency class:
Industry
Source:
Canadian Cancer Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05714891
