New drug shows promise in shrinking lung tumors before surgery
NCT ID NCT05714891
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests the drug JDQ443 in people with non-small cell lung cancer before they have surgery. The goal is to see if the drug can shrink tumors and improve outcomes. Only 4 participants are enrolled, so results are very early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JDQ443
- What this could lead to
- If successful, this could identify a new treatment option to shrink lung cancer tumors before surgery, potentially improving outcomes.
- What could go wrong
- This is a very early, small trial with only 4 participants. The drug may not work as hoped, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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4 people
The number who actually took part.
- Started
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Sep 2023
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4, Canada
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CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
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Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7, Canada
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London Health Sciences Centre Research Inc.
London, Ontario, N6A 5W9, Canada
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Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6, Canada
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The Research Institute of the McGill University
Montreal, Quebec, H4A 3J1, Canada
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University Health Network
Toronto, Ontario, M5G 2M9, Canada
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University Institute of Cardiology and
Québec, Quebec, G1V 4G5, Canada
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