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Clinical Trials List

Protocol NumberJ3M-MC-JZQH
NCT Number(ClinicalTrials.gov Identfier)NCT06890598
Not yet recruiting

2025-04-01 - 2032-12-31

Recruiting18

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 Phase 3, Multicenter, Double-Blind, Placebo-controlled Study Assessing the Efficacy and Safety of Olomorasib in Combination With Standard of Care Immunotherapy in Participants With Resected or Unresectable KRAS G12C-Mutant, Non-Small Cell Lung Cancer - SUNRAY-02

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/05/21

Investigators and Locations

Principal Investigator James Chih-Hsin Yang Division of Hematology & Oncology
National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張晟瑜 Division of Thoracic Medicine
Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良 Division of Thoracic Medicine
Dalin Tzu Chi Hospital Buddhist Tzu Chi Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 鄭舒帆 Division of Thoracic Medicine
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 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 Recruiting

Principal Investigator Cheng-Ta Yang Division of Hematology & Oncology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of General Internal Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yuh-Min Chen Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林聖皓 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Yu Chen Division of Thoracic Medicine
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林智斌 Division of Thoracic Medicine
Hualien Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 魏裕峰 Division of Thoracic Medicine
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Carcinoma, Non-Small-Cell Lung

Objectives

The aim of this trial is to determine the efficacy of olomorasib combined with standard care immunotherapy following decisive chemotherapy for NSCLC. Part A is designed for resected stage II-IIIB NSCLC, adding existing standard care (through a surgical approach or adjuvant therapy), regardless of tumor PD-L1 status. Part B is designed for unresectable stage III NSCLC, adding existing standard care (consolidation durvalumab after decisive chemoradiotherapy), regardless of tumor PD-L1 status.

Test Drug

Capsules
Intravenous infusion
Intravenous infusion

Active Ingredient

Olomorasib
Durvalumab
Pembrolizumab

Dosage Form

130
246
246

Dosage

MG

Endpoints

Part A: Does adding olomorasib to pembrolizumab, compared to placebo and pembrolizumab, prolong disease-free survival (DFS) in participants with pathologically confirmed resected stage II-IIIB NSCLC? (These participants had a KRAS G12C mutation, PD-L1 performance ranging from 0% to 100%, and had previously received chemotherapy.)

Part B: Does adding olomorasib to durvalumab, compared to placebo and durvalumab, prolong disease-free survival (PFS) in participants with pathologically confirmed unresectable stage III NSCLC? (These participants had a KRAS G12C mutation, had not experienced disease progression after concurrent platinum-based chemotherapy and radiation therapy, and had PD-L1 performance ranging from 0% to 100%.)

Inclution Criteria

Inclusion Criteria:

Histological or cytological confirmation of NSCLC.

Part A

Clinical Stage II-IIIB (N2) treated with presurgical chemoimmunotherapy, with residual tumor present at time of surgery. Patients with a pathologic complete response are not eligible.
Pathologic Stage II-IIIB (N2) NSCLC treated with initial upfront resection.
Part B - Clinical Stage III, unresectable NSCLC, without progression on concurrent platinum-based chemoradiotherapy.
Must have disease with evidence of KRAS G12C mutation.
Must have known programmed death-ligand 1 (PD-L1) expression
Must have an ECOG performance status of 0 or 1.
Able to swallow oral medication.
Must have adequate laboratory parameters.
Contraceptive use should be consistent with local regulations for those participating in clinical studies.
Women of childbearing potential must

Have a negative pregnancy test.
Not be breastfeeding during treatment

Exclusion Criteria

Exclusion Criteria:

Have known changes in the EGFR or ALK genes.
Have another type of cancer that is progressing or required active treatment within the past 2 years before screening.
Have an active autoimmune disease that required systemic treatment in the past 2 years. Endocrine replacement therapy is allowed.
Had any immune-related side effect or allergic reaction (Grade 3 or higher) from a previous immunotherapy medicine, or any immune-related side effect greater than Grade 1 that has not resolved. This does not apply for people with hormone-related diseases who are now on stable hormone replacement therapy.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    700 participants

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