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JDQ443 for Non-Small Cell Lung Cancer
Phase 2
Recruiting
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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. Patients with multistation N2 disease are not eligible unless otherwise specified in a specific substudy
Patients must be ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial looks at how new treatments affect non-small cell lung cancer before surgery.
Who is the study for?
Adults with newly diagnosed non-small cell lung cancer (NSCLC) that can be removed by surgery are eligible. They should not have had previous cancer treatments, must be in good physical condition (ECOG 0 or 1), and have their major organs functioning well. Women and men who can have children must agree to use effective birth control. People with advanced, unresectable or metastatic cancer, serious medical conditions, certain heart diseases, or a history of significant allergies to similar drugs cannot participate.Check my eligibility
What is being tested?
The trial is testing JDQ443 as a new treatment for NSCLC before surgery. Participants will receive this medication within a specific timeframe prior to their planned surgical procedure aimed at completely removing the cancer. The study aims to evaluate how effective JDQ443 is when given before surgery in improving outcomes for patients.See study design
What are the potential side effects?
While the specific side effects of JDQ443 are not listed here, common side effects from similar treatments may include nausea, fatigue, increased risk of infection due to lowered immune response, potential liver function changes, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is in an early to mid-stage and can be removed with surgery, but I don't have widespread lymph node involvement.
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I am 18 years old or older.
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I have had the required scans and tests for lung cancer staging.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Identify promising neoadjuvant treatment regimens for NSCLC for later validation in randomized clinical trials, by evaluating major pathological response rates (MPR)
Secondary outcome measures
Access to surgery (rate of open, video-assisted and robotic-assisted thoracic surgery)
Completeness of surgical resection using the Residual (R) Tumor Classification
Event-free survival at 2 years
+7 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Neoadjuvant therapy (JDQ443) followed by surgery.Experimental Treatment1 Intervention
If *MPR/cPR* - standard of care adjuvant treatment may be followed by experimental adjuvant therapy (JDQ443)
*Major Pathological Response (MPR)/ Complete Pathological Response (cPR)
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,460 Total Patients Enrolled
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,008 Total Patients Enrolled
Jonathan SpicerStudy ChairMcGill University, Montreal, QC Canada
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer diagnosis was confirmed by a lab test within the last 3 months.My organ and bone marrow functions are currently healthy.I do not have serious heart rhythm problems or a family history of them.I am using a highly effective method of birth control.I am 18 years old or older.I am willing and able to fill out a questionnaire about my health outcomes.I have had the required scans and tests for lung cancer staging.My surgery is scheduled 2-4 weeks after my last pre-surgery treatment.I have more than one lung tumor, but they all can be surgically removed and are not active on PET scans.My cancer is in an early to mid-stage and can be removed with surgery, but I don't have widespread lymph node involvement.You had another type of cancer before, but it's been treated and doesn't affect the safety or effectiveness of the new treatment being studied.You have had a bone marrow, double umbilical cord blood, or solid organ transplant in the past.I have not had cancer treatment for NSCLC before, but if I did for early stages, it needs approval.I do not have serious heart problems or uncontrolled high blood pressure.My cancer cannot be surgically removed or has spread to other parts of my body.I cannot take pills by mouth or have a stomach condition that affects medication absorption.You have a history of not following your doctor's instructions for taking medication.You must have a disease that can be measured and evaluated according to specific guidelines. It's better if the disease can be measured.I am fully active or restricted in physically strenuous activity but can do light work.My surgery will follow standard care and aims for complete tumor removal.
Research Study Groups:
This trial has the following groups:- Group 1: Neoadjuvant therapy (JDQ443) followed by surgery.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized Neoadjuvant therapy (JDQ443) to be used in conjunction with surgical procedures?
"Our team at Power assessed the safety of Neoadjuvant therapy (JDQ443) followed by surgery as a 2, as there is clinical evidence indicating its safety but none demonstrating efficacy."
Answered by AI
What is the cap on total enrolment for this trial?
"Affirmative. The details hosted on clinicaltrials.gov highlight that this medical investigation, which was initially posted on May 26th 2023, is actively enrolling participants. Approximately 27 people must be recruited from 2 distinct medical sites."
Answered by AI
Is enrollment for this research still open?
"Affirmative. Clinicaltrials.gov attests that this clinical trial, which was posted on May 26th 2023, is still actively recruiting patients. A total of 27 participants need to be enrolled at 2 separate research centres."
Answered by AI
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