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Clinical Trials List

Protocol NumberJ3M-MC-JZQB

NCT Number(ClinicalTrials.gov Identfier)NCT06119581

2024-01-01 - 2030-12-31

Phase III

Recruiting14

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

Eli Lilly and Company (Taiwan), Inc.
Trial scale

Multi-Regional Multi-Center
Update

2025/10/29

Investigators and Locations

Principal Investigator Gee-chen Chang 無

Chung Shan Medical University Hospital

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 黃文聰無

Chi Mei Hospital, Liouying

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 Cheng-Ta Yang 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHIN-CHOU WANG 無

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 Chia-Chi Lin 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Yu Chen 無

National Taiwan University Hospital Yunlin Branch

Co-Principal Investigator

陳祐易無
王馨儀無

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 林聖皓無

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 Yuh-Min Chen 無

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin Division of General Internal Medicine

National Taiwan University 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

Condition/Disease

Carcinoma, Non-Small-Cell Lung

Objectives

The disease studied in this trial is KRAS G12C mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC). KRAS G12C inhibitors have demonstrated clinical benefit in advanced non-small cell lung cancer that has progressed after at least 1 prior line of therapy. Using the currently approved standard anti-PD-1 therapy as the first-line treatment for KRAS G12C-mutated NSCLC, anti-PD-1 固醇治療的特定肺部疾病病史，或目前患有引發您症狀的特定類型肺部疾病。 ‧您患有本試驗不允許的特定病況、影響您免疫系統的疾病或活動性感染。試驗醫師將與您討論這個部分。 ‧您在開始試驗藥物前21天內接受過重大手術。 ‧您具有由您的試驗醫師判定之嚴重既有醫療狀況。 ‧您納入其他試驗醫師判定為不允許的臨床試驗。 ‧您對LY3537982、pembrolizumab、pemetrexed或含platinum藥物、或其任何成分過敏。 ‧您具有可能影響您消化試驗藥物的消化系統病況。 ‧您曾接受捐贈的組織、器官或幹細胞移植。針對安全性導入B部分及B部分 ‧您無法或不願意服用葉酸或維生素B12補充劑。 ‧您無法中斷除阿斯匹靈外之非類固醇消炎藥物(NSAIDs)。

Test Drug

Carboplatin|Cisplatin|LY3537982|Pembrolizumab|Pemetrexed|Placebo

Active Ingredient

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

Dosage Form

N/A

Dosage

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

Endpoints

• Dose Optimization and Safety Lead-in Part B: Number of participants with treatment-emergent adverse events (TEAEs)
[Time Frame: From randomization to the first documented disease progression or death from any cause (estimated duration: approximately 1 year)].

• Dose Optimization and Safety Lead-in Part B: Number of participants with TEAEs.

• Parts A and B: Progression-Free Survival (PFS)
[Time Frame: From randomization to the first documented disease progression or death from any cause (estimated duration: approximately 1 year)].
PFS will be assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

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 and after study intervention for at least 180 days.

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)
-Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted.
-Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
-Is unable or unwilling to take folic acid or vitamin B12 supplementation.

The Estimated Number of Participants

Taiwan

60 participants
Global

1016 participants