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NSCLCPhase 2NCT05714891

Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer

A Phase 2 study testing JDQ443 in people with NSCLC, run by Canadian Cancer Trials Group at 8 sites in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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? Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NSCLC
What is being tested?
JDQ443
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
8 sitesCanada
Study dates
15 Sep 2023to 31 Mar 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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;,
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Canada8 sites

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • The Research Institute of the McGill University

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • University Institute of Cardiology and

    Québec, Quebec, G1V 4G5

  • University Health Network

    Toronto, Ontario, M5G 2M9

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

Official title: Neoadjuvant Platform Trial in Patients With Surgically Resectable Non-Small Cell Lung Cancer (NSCLC)

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?

Read the 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.

Conditions
NSCLC
Being tested
JDQ443

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JDQ443Drug

    Dose will be assigned at enrollment

Study groups in NCT05714891
Study groupRoleWhat they receive
Neoadjuvant therapy (JDQ443) followed by surgery. (ARM CLOSED)ExperimentalIf *MPR/cPR* - standard of care adjuvant treatment may be followed by experimental adjuvant therapy (JDQ443) *Major Pathological Response (MPR)/ Complete Pathological Response (cPR)
Receives: Drug: JDQ443

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify promising neoadjuvant treatment regimens for NSCLC for later validation in randomized clinical trials, by evaluating major pathological response rates (MPR)

    Measured: 3 years

Secondary outcomes (10)

  1. Number and severity of adverse events as per CTCAE version 5.0

    Measured: 3 years

  2. Overall response rate using RECIST 1.1

    Measured: 3 years

  3. Pathological complete response rate (pCR)

    Measured: 3 years

  4. Event-free survival at 2 years

    Measured: 3 years

  5. Completeness of surgical resection using the Residual (R) Tumor Classification

    Measured: 3 years

  6. Access to surgery (rate of open, video-assisted and robotic-assisted thoracic surgery)

    Measured: 3 years

  7. Rate (and reasons) of surgical access conversion (from video-assisted or robotic-assisted thoracic surgery to open surgery)

    Measured: 3 years

  8. Extent of surgery (rate of surgery types: wedge resection, segmentectomy, lobectomy, completion lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, major airway resection, and other)

    Measured: 3 years

  9. Extent of perihilar/lobar fibrosis and mediastinal adhesions (as per the Lee et al. (JTO, 2021) grading scale)

    Measured: 3 years

  10. Tumour downstaging: rate of patients with post-surgical downstaging when comparing cTNM and pTNM

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2023
  2. Study start15 Sep 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05714891
Sponsor's protocol ID
I242
Status last verified
Oct 2026
First submitted
4 Jan 2023
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JDQ443 in people with NSCLC, run by Canadian Cancer Trials Group at 8 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05714891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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