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Clinical Trials List

Protocol NumberJ3M-MC-JZQB

NCT Number(ClinicalTrials.gov Identfier)NCT06119581

Active

2024-01-01 - 2030-12-31

Phase III

Recruiting17

ICD-10C34.2

Malignant neoplasm of middle lobe, bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.4

Malignant neoplasm of middle lobe, bronchus or lung

SUNRAY-01, A Global Pivotal Study in Participants With KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in Those With PD-L1 Expression ≥50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum Regardless of PD-L1 Expression

Trial Applicant

ELI LILLY AND COMPANY(TAIWAN), INC.
Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Chung-Yu Chen 無

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 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林智斌無

Hualien Tzu Chi Hospital

Co-Principal Investigator

王佐輔無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator James Chih-Hsin Yang 無

National Taiwan University Cancer Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴俊良無

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 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 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 Yuh-Min Chen 無

Taipei Veterans General 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 林聖皓 Division of Thoracic Medicine

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TSUNG -YING YANG 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭雨萱 Division of Hematology & Oncology

Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jih-Hsiang Lee 無

National Taiwan University Hospital Hsin-Chu Branch

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

Principal Investigator

National Taiwan University Hospital Yunlin Branch

Co-Principal Investigator

王馨儀無
陳祐易無

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Carcinoma, Non-Small-Cell Lung 、Neoplasm Metastasis

Objectives

The aim of this study is to evaluate whether LY3537982 combined with standard care anticancer drugs is more effective than standard care in participants with untreated advanced NSCLC. NSCLC must involve a mutation in a gene called KRAS G12C. Study participation (including follow-up) may last up to 3 years, depending on you and your lung cancer condition.

Test Drug

N/A
N/A
N/A
N/A
N/A

Active Ingredient

Pembrolizumab
CARBOPLATIN
CISPLATIN (CIS-DDPDDP)
PEMETREXED DISODIUM HEPTAHYDRATE
LY3537982
Placebo

Dosage Form

N/A
N/A
N/A
N/A
N/A
N/A

Dosage

200mg / 400mg
10mg/ml
50mg
500mg
25mg / 50mg

Endpoints

• Dosage Optimization and Safety Introduction Part B: Number of participants who experienced a treatment-emergent adverse event (TEAE) [Timeframe: Randomization to first recorded disease progression or death from any cause. (Estimated approximately 1 year)]

Dosage Optimization and Safety Introduction Part B: Number of participants who experienced a TEAE

• Parts A and B: Progression-Free Survival (PFS) [Timeframe: Randomization to first recorded disease progression or death from any cause. (Estimated approximately 1 year)]

Blinded Independent Central Review (BICR) PFS according to the Responsive Evaluation Criteria for Solid Tumors (RECIST) v1.1

Inclution Criteria

Inclusion Criteria:

Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
Must have disease with evidence of KRAS G12C mutation.
Must have known programmed death-ligand 1 (PD-L1) expression

Part A: Greater than or equal to (≥)50 percent (%).
Part B: 0% to 100%.
Must have measurable disease per RECIST v1.1.
Must have an ECOG performance status of 0 or 1.
Estimated life expectancy ≥12 weeks.
Ability to swallow capsules.
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 a documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3.
Have had any of the following prior to randomization:

-- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.

--- 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:

Have known active central nervous system metastases and/or carcinomatous meningitis.
Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)

Have predominantly squamous cell histology for NSCLC
Only for participants with mild to moderate renal insufficiency: Unable to avoid aspirin, ibuprofen, or other nonsteroidal anti-inflammatory drugs (NSAIDs) two days before (5 days for long acting NSAIDs), day of, and two days after administration of pemetrexed
Is unable or unwilling to take folic acid or vitamin B12 supplementation.

The Estimated Number of Participants

Taiwan

60 participants
Global

1016 participants