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Clinical Trials List

Protocol NumberJ3M-MC-JZQH
NCT Number(ClinicalTrials.gov Identfier)NCT06890598
Active

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 trial evaluating the efficacy and safety of olomorisabin 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 Taiwan

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/08/10

Investigators and Locations

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 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 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 無
Far Eastern Memorial 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 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 無
Chung Shan Medical University Hospital

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 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 無
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 無
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 Cheng-Ta Yang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

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 non-small cell lung cancer? (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%.)

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

Durvalumab
Olomorasib
PembrolizumabDurvalumab

Active Ingredient

Durvalumab
Olomorasib
PembrolizumabDurvalumab

Dosage Form

Intravenous infusion solution
Capsule solution
Intravenous infusion solution

Dosage

mg/ml
MG
mg/ml

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

Age

1. Must be at least 18 years of age, meeting the legal age of consent required by local law.

Participant Type and Disease Characteristics

2. Must have histologically or cytologically confirmed NSCLC (non-small cell lung cancer).

3. Must have evidence of KRAS G12C mutation confirmed by tumor or blood samples, as determined by molecular testing performed in a certified laboratory.

4. Must have known PD-L1 expression status of tumor cells (0% to 100%), as determined by IHC assay performed in a certified laboratory.

5. Must have an ECOG performance status score of 0 or 1.

6. Must have adequate organ and bone marrow function as defined in the trial protocol.

Previous Treatment

7. Must have recovered from any previous surgical procedures prior to randomization.

Contraception and Barrier Contraception Requirements

8. Participants must use contraceptive methods that comply with local regulations regarding contraceptive use for participants in clinical trials.

Other Inclusion Criteria

9. Those born female must have evidence of postmenopause, or those of fertility must have a negative pregnancy test result (serum test recommended) at screening, and a negative serum or urine test result within 72 hours prior to receiving the trial intervention.

10. Able to swallow medication.

Subject Consent Form

11. Able to sign an informed consent form, including compliance with the Subject Consent Form (ICF) and the provisions and restrictions listed in this trial plan.

Part A: Participant Types and Disease Characteristics

12. Stage II-IIIB (N2) NSCLC, including one of the following:

a. Clinically Stage II-IIIB (N2), treated with preoperative chemoimmunotherapy, and with residual tumor at the time of surgery. Patients with a complete pathological response are ineligible.

b. Pathologically Stage II-IIIB (N2) NSCLC, and directly resected.

13. Previously underwent radical resection, defined as lobectomy, sleeve lobectomy, bilateral lobectomy, or pneumonectomy. En bloc resection, such as chest wall resection, or sublobar resection, such as wedge resection or pulmonary segment resection, can only be performed concurrently with any resection for the aforementioned radical purposes.

14. No evidence of disease recurrence on clinical examination and baseline radiological assessment, confirmed by contrast-enhanced chest/upper abdomen CT scan, contrast-enhanced brain CT/MRI scan, and clinical examination within 28 days prior to the first dose of trial intervention.

Part B Part Participant Type and Disease Characteristics

15. Clinical stage III unresectable NSCLC that has not worsened while receiving platinum-based chemoradiotherapy.

Previous Treatment

16. Must have received prior chemotherapy. Prior immune checkpoint inhibitor therapy is permissible, but must be administered in conjunction with preoperative adjuvant chemotherapy.

Exclusion Criteria

Medical Conditions

1. Having one of the tumor types defined in the trial protocol.

2. Known EGFR (glomerular filtration rate) mutation or ALK chromosomal recombination.

3. Known malignancy within the past 3 years prior to screening, which is worsening or requires aggressive treatment.

4. Currently or previously having non-infectious pneumonia or interstitial lung disease requiring steroid treatment.

5. Having an active, uncontrolled infection requiring systemic therapy.

6. Having undergone allogeneic tissue or solid organ transplantation.

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

8. Diagnosed with primary immunodeficiency within 7 days prior to receiving the first dose of trial intervention, or currently receiving systemic steroid therapy or any form of immunosuppressive therapy.

9. Currently or previously confirmed inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.

10. Known history of HIV infection (positive for HIV-1 or HIV-2 antibodies). 11. HBV infection with a history of or current infection with one of the conditions described in the trial protocol.

12. Current HCV infection, defined as HCV RNA positive.

13. Known history of active tuberculosis.

14. Clinically significant active cardiovascular disease, or a history of myocardial infarction or unstable angina, within 6 months prior to the scheduled start of the trial.

15. Serious pre-existing medical conditions that, in the opinion of the trial administrator, may preclude participation in this trial, including but not limited to substance use disorder, unstable mental health conditions, severe dyspnea at rest, or the need for oxygen therapy. Screening for chronic conditions is not required.

16. Active malabsorption syndrome or other conditions that may affect the ability to receive gastrointestinal absorption of the trial intervention.

Previous and Concurrent Clinical Trial Experience

17. Enrolled in any other clinical trial using the investigational drug within 4 weeks prior to administration of the first dose of the trial intervention.

18. Currently participating in any type of medical research deemed scientifically or medically incompatible with this trial.

Other Exclusion Criteria

19. Currently pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial or within 180 days of receiving the last dose of the trial intervention.

Part A: Previous and Concurrent Treatments

20. For patients undergoing direct surgical resection, having received more than 4 cycles of adjuvant chemotherapy.

21. For patients receiving preoperative chemoimmunotherapy, having received any adjuvant therapy.

Part B: Previous and Concurrent Treatments

22. Having received a non-standard care treatment regimen, such as induction chemotherapy plus immunotherapy, followed by chemoradiotherapy.

23. Having received chemotherapy and radiation therapy sequentially.

24. Having grade 2 or higher pneumonia caused by previous chemoradiotherapy.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    700 participants

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