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Clinical Trials List

Protocol NumberJ3M-MC-JZQH
Not yet recruiting

2025-04-01 - 2032-12-31

Phase III

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

    Eli Lilly and Company (Taiwan), Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

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 Chien-Chung Lin Division of Thoracic Medicine
National Taiwan University 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 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 Jen-Yu Hung
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

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

Condition/Disease

Non–small cell lung cancer (NSCLC)

Objectives

The purpose of this study is to determine the efficacy of olomorasib in combination with standard-of-care (SOC) immunotherapy following definitive therapy for non–small cell lung cancer (NSCLC). Part A is designed for patients with resected Stage II–IIIB NSCLC, in which olomorasib is added to the current SOC (either in the perioperative or adjuvant setting), regardless of tumor PD-L1 status. Part B is designed for patients with unresectable Stage III NSCLC, in which olomorasib is added to the current SOC (following definitive chemoradiotherapy with consolidative durvalumab), regardless of tumor PD-L1 status.

Test Drug

Durvalumab
Olomorasib
Pembrolizumab

Active Ingredient

Durvalumab
Olomorasib
Pembrolizumab

Dosage Form

130
246
246

Dosage

MG

Endpoints

Part A:
To determine whether adding olomorasib to pembrolizumab, compared with placebo plus pembrolizumab, can prolong disease-free survival (DFS) in participants with pathologically confirmed, resected Stage II–IIIB NSCLC who harbor a KRAS G12C mutation, have PD-L1 expression between 0% and 100%, and have previously received chemotherapy.

Part B:
To determine whether adding olomorasib to durvalumab, compared with placebo plus durvalumab, can prolong progression-free survival (PFS) in participants with pathologically confirmed, unresectable Stage III NSCLC who harbor a KRAS G12C mutation, have not experienced disease progression following platinum-based chemoradiotherapy, and have PD-L1 expression between 0% and 100%.

Inclution Criteria

Age

Participants must be at least 18 years of age (or older, as required by local regulations for providing informed consent).

Participant Type and Disease Characteristics
2. Histologically or cytologically confirmed diagnosis of non–small cell lung cancer (NSCLC).
3. Documented evidence of a KRAS G12C mutation in tumor tissue or blood, as determined by a validated molecular test performed at a certified laboratory.
4. Known PD-L1 expression status (0%–100%), as determined by IHC testing performed at a certified laboratory.
5. ECOG performance status of 0 or 1.
6. Adequate organ and bone marrow function as defined in the protocol.

Prior Therapy
7. Participants must have recovered from any prior surgical procedures before randomization.

Contraception and Barrier Protection Requirements
8. Contraceptive methods used by participants must comply with local regulations regarding contraception in clinical trial participation.

Other Inclusion Criteria
9. Females of non-childbearing potential must provide evidence of postmenopausal status; females of childbearing potential must have a negative pregnancy test (preferably serum) at screening and a negative serum or urine test within 72 hours prior to the first administration of study intervention.
10. Must be able to swallow oral medication.

Informed Consent
11. Must be able to sign the informed consent form (ICF) and comply with the requirements and restrictions specified in the ICF and protocol.

Part A: Participant Type and Disease Characteristics

Stage II–IIIB (N2) NSCLC, including one of the following:
a. Clinically Stage II–IIIB (N2) disease that received neoadjuvant chemo-immunotherapy and had residual tumor at surgery. Participants who achieved pathologic complete response (pCR) are not eligible.
b. Pathologically Stage II–IIIB (N2) NSCLC that underwent primary surgical resection.

Must have undergone curative-intent resection, defined as lobectomy, sleeve lobectomy, bilobectomy, or pneumonectomy. En bloc resections (e.g., chest wall resection) or sublobar resections (e.g., wedge or segmentectomy) are allowed only if performed together with one of the curative-intent procedures listed above.

No evidence of disease recurrence based on clinical examination and baseline imaging (contrast-enhanced CT of the chest/upper abdomen, contrast-enhanced brain CT/MRI, and clinical assessment) performed within 28 days prior to the first study intervention.

Part B: Participant Type and Disease Characteristics

Clinically Stage III, unresectable NSCLC, with no disease progression following platinum-based concurrent chemoradiotherapy.

Prior Therapy
16. Must have previously received chemotherapy. Prior treatment with an immune checkpoint inhibitor is allowed only if administered in combination with neoadjuvant chemotherapy.

Exclusion Criteria

Medical Conditions

Has one of the tumor types defined in the study protocol.

Has a known EGFR mutation or ALK gene rearrangement.

Has a known malignancy within 3 years prior to screening that is progressing or requires active treatment.

Has current or prior noninfectious pneumonitis or interstitial lung disease requiring corticosteroid treatment.

Has an active, uncontrolled infection requiring systemic therapy.

Has a history of allogeneic tissue or solid organ transplantation.

Has had an active autoimmune disease requiring systemic treatment within the past 2 years.

Has been diagnosed with a primary immunodeficiency within 7 days prior to the first study intervention or is receiving systemic corticosteroids or any other form of immunosuppressive therapy.

Has current or prior inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis.

Has a known history of HIV infection (positive for HIV-1 or HIV-2 antibodies).

Has current or prior hepatitis B virus (HBV) infection as described in the protocol.

Has active hepatitis C virus (HCV) infection, defined as HCV RNA positive.

Has a known history of active tuberculosis (TB).

Has had clinically significant active cardiovascular disease, or a history of myocardial infarction or unstable angina within 6 months prior to study initiation.

Has, in the opinion of the investigator, a serious preexisting medical condition that could interfere with participation in this study, including but not limited to substance use disorder, unstable psychiatric illness, severe dyspnea at rest, or requirement for supplemental oxygen. Chronic stable conditions do not require exclusion screening.

Has active malabsorption syndrome or any other condition that may impair gastrointestinal absorption of the study intervention.

Prior and Concomitant Clinical Trial Experience
17. Has participated in another clinical trial involving an investigational drug within 4 weeks prior to the first dose of study intervention.
18. Is currently participating in any medical research that is, in the opinion of the investigator, scientifically or medically incompatible with this study.

Other Exclusion Criteria
19. Is pregnant or breastfeeding, or intends to become pregnant or breastfeed during the study or within 180 days after the last dose of study intervention.

Part A: Prior and Concomitant Therapy

For participants who underwent direct surgical resection, has received more than 4 cycles of adjuvant chemotherapy.

For participants who received neoadjuvant chemo-immunotherapy, has received any adjuvant therapy thereafter.

Part B: Prior and Concomitant Therapy

Has received a non–standard-of-care treatment regimen, such as induction chemotherapy plus immunotherapy followed by chemoradiotherapy.

Has received sequential chemotherapy and radiotherapy (rather than concurrent chemoradiation).

Has experienced Grade ≥2 pneumonitis resulting from prior chemoradiotherapy.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    700 participants

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