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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
Cancer Categories
Lung
Karmanos Trial ID
2023-101
NCT ID
NCT06119581
Age Group
Adult
Scope
National
Phase
Phase III
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase III
Principal Investigator
Dipesh
Uprety, M.D.
Oncology - Medical
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Objective:
Primary Objectives:
Dose Optimization
To determine the optimal dose of LY3537982 (50 or 100 mg BID) to be administered in combination with pembrolizumab
Part A
To compare the efficacy of LY3537982 in combination with pembrolizumab versus placebo with pembrolizumab
Secondary Objectives:
Part A
To compare the efficacy of LY3537982 in combination with pembrolizumab versus placebo with pembrolizumab
To compare the safety profile of LY3537982 in combination with pembrolizumab and placebo with pembrolizumab
To compare changes in NSCLCrelated symptoms between LY3537982 in combination with pembrolizumab versus placebo with pembrolizumab
To compare changes in physical function between LY3537982 in combination with pembrolizumab versus placebo with pembrolizumab
To compare patient-reported treatment burden between LY3537982 in combination with pembrolizumab versus placebo with pembrolizumab
To compare changes in healthrelated quality of life between LY3537982 in combination with pembrolizumab versus placebo with pembrolizumab
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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:
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.
Lead-In Part B)
Have predominantly squamous cell histology for NSCLC
Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
Get Directions
Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Lung
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Chemotherapy, Immunotherapy
Drugs
Carboplatin; Cisplatin; LY3537982; Pembrolizumab; Pemetrexed; Placebo
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