Neoadjuvant Platform Trial in Non-Small Cell Lung Cancer

NCT05714891 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: I242
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 8

Brief 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?

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (10)

• Number and severity of adverse events as per CTCAE version 5.0

  3 years

• Overall response rate using RECIST 1.1

  3 years

• Pathological complete response rate (pCR)

  3 years

• Event-free survival at 2 years

  3 years

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

  3 years

Study Arms (1)

Neoadjuvant therapy (JDQ443) followed by surgery. (ARM CLOSED)

EXPERIMENTAL

If \*MPR/cPR\* - standard of care adjuvant treatment may be followed by experimental adjuvant therapy (JDQ443) \*Major Pathological Response (MPR)/ Complete Pathological Response (cPR)

Drug: JDQ443

Interventions

JDQ443 DRUG

Dose will be assigned at enrollment

Neoadjuvant therapy (JDQ443) followed by surgery. (ARM CLOSED)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Novartis: collaborator

Study Sites (8)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

London Health Sciences Centre Research Inc.

London, Ontario, N6A 5W9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2X 3E4, Canada

Location

The Research Institute of the McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

University Institute of Cardiology and

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Interventions

JDQ443

Study Officials

• Jonathan Spicer

  McGill University, Montreal, QC Canada

  STUDY CHAIR

• Normand Blais

  CHUM-Centre Hospitalier de l'Universite de Montreal, QC Canada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: February 6, 2023
• Study Start: September 15, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): March 31, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8)