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New drug shows promise in shrinking lung tumors before surgery

NCT ID NCT05714891

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

4 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4, Canada

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9, Canada

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9, Canada

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1, Canada

  • University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • University Institute of Cardiology and

    Québec, Quebec, G1V 4G5, Canada

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Other studies related to the condition(s) this trial covers.