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Clinical Trials List

Protocol NumberCJDQ443B12301

NCT Number(ClinicalTrials.gov Identfier)NCT05132075

Active

2022-08-12 - 2027-02-20

Phase III

Not yet recruiting2

Recruiting1

Terminated2

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

A Randomized, Controlled, Open Label, Phase III Study Evaluating the Efficacy and Safety of JDQ443 Versus Docetaxel in Previously Treated Subjects With Locally Advanced or Metastatic KRAS G12C Mutant Non-small Cell Lung Cancer

Trial Applicant

NOVARTIS (TAIWAN) CO., LTD.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Yung-Hung Luo 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Ta Yang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Chung Lin Division of Thoracic Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Gee-chen Chang Division of Thoracic Medicine

Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Te-Chun Hsia 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Non-Small Cell Lung Cancer

Objectives

The aim of this trial was to compare JDQ443 as monotherapy with docetaxel in patients with advanced non-small cell lung cancer with a KRAS G12C mutation who had received prior platinum-based chemotherapy and an immune checkpoint inhibitor, either sequentially or in combination.

Test Drug

JDQ443

Active Ingredient

JDQ443

Dosage Form

Tablet

Dosage

100 mg

Endpoints

Efficacy evaluation
● Randomized part: Tumor assessment using RECIST 1.1 was performed every 6 weeks starting from Day 1 of Cycle 1 (C1D1) to Week 54, and then every 12 weeks until disease progression, death, loss to follow-up, or withdrawal of subject consent/objection to use of data/biological specimens as judged by the trial sponsor and confirmed by the blinded independent review committee (BIRC).
● Extension: Tumor assessments using RECIST 1.1 were performed every 12 weeks until 3 years after randomization and every 6 months thereafter until disease progression was confirmed by the trial sponsor.
● Survival status was collected every 12 weeks.
Pharmacokinetic evaluation
JDQ443 PK will be assessed in the randomized portion of participants who receive JDQ443 (including those who switch treatment).
Key Safety Assessments
● Physical examination.
● Eastern Cooperative Oncology Group (ECOG) performance status (PS).
● Weight and vital signs.
● Adverse events (AEs).
● Abnormal laboratory test results.
● Abnormal electrocardiogram (ECG) and cardiac magnetic resonance imaging (CMR) or cardiac ultrasound
Other evaluation items
● Patient-rated outcomes (PROs): NSCLC-Symptom Assessment Questionnaire (SAQ), EORTC QLQ-C30, EORTC QLQ-LC13, and EQ-5D-5L.
● Biomarker tumor and blood samples

Inclution Criteria

Inclusion Criteria:

Participant has histologically confirmed locally advanced/metastatic (stage IIIB/IIIC or IV)
Participant has a KRAS G12C mutation present in tumor tissue or plasma prior to enrollment, as determined by a Novartis designated central laboratory or by accepted local tests.
Participants has received one prior platinum-based chemotherapy regimen and one prior immune checkpoint inhibitor therapy for locally advanced or metastatic disease
Participant has at least 1 evaluable (measurable or non-measurable) lesion by RECIST 1.1 at the screening visit.

Exclusion Criteria

Exclusion Criteria:

Participants who have previously received docetaxel (except if received in neoadjuvant or adjuvant setting with no progression within 12 months after the of end of treatment), or any other KRAS G12C inhibitor.
Participant has EGFR-sensitizing mutation and/or ALK rearrangement by local laboratory testing. Participants with other druggable alterations will be excluded if required by local guidelines.
Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
Participant has an history of interstitial lung disease or pneumonitis grade > 1.

The Estimated Number of Participants

Taiwan

3 participants
Global

360 participants