SUNRAY-01 J3M-MC-JZQB
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 summary:
The purpose of this study is to assess if adding LY3537982 in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C. Study participation, including follow-up, could last up to 3 years, depending on how you and your lung cancer are doing.
Receptor status / problem studied:
Inclusion criteria
1) Histologically or cytologically confirmed NSCLC with Stage IIIB-IIIC or Stage IV disease, not suitable for curative intent radical surgery or radiation therapy.
2) Part B and Safety Lead-In Part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label).
3) Must have disease with evidence of KRAS G12C mutation.
4) Must have known programmed death-ligand 1 (PD-L1) expression.
|— a) Part A: Greater than or equal to (≥)50 percent (%).
|— b) Part B: 0% to 100%.
5) Must have measurable disease per RECIST v1.1.
6) Must have an ECOG performance status of 0 or 1.
7) Estimated life expectancy ≥12 weeks.
8) Ability to swallow capsules.
9) Must have adequate laboratory parameters.
10) Contraceptive use should be consistent with local regulations for those participating in clinical studies.
11) Women of childbearing potential must:
|— a) Have a negative pregnancy test.
|— b) Not be breastfeeding during treatment and after study intervention for at least 180 days.
Exclusion criteria
1) 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.
2) Have had any of the following prior to randomization:
|— a) Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.
|— b) 1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:
3) Have known active central nervous system metastases and/or carcinomatous meningitis.
4) Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B):
|— a) Squamous cell and/or mixed small cell/nonsmall cell histology is not permitted.
|— b) Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs).
|— c) Is unable or unwilling to take folic acid or vitamin B12 supplementation.
Trial Title
SUNRAY-01 J3M-MC-JZQB
Diagnosis
Lung cancer
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
III