KRAS G12C Inhibitor
Olomorasib
Phase
3
Enrolling
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*
Related Resources:
Key Inclusion Criteria
- Histologically or cytologically confirmed non-small cell lung cancer (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)
- Disease with evidence of KRAS G12C mutation
- Known programmed death-ligand 1 (PD-L1) expression
- Part A: ≥50%
- Part B: 0%-100%
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy ≥12 weeks
- Ability to swallow capsules
- 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
Key Exclusion Criteria
- 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
- Had any of the following prior to randomization:
- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC
- One cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated
- Central nervous system (CNS) metastases and/or carcinomatous meningitis
- For participants receiving pemetrexed and platinum (part B and safety lead-in part B):
- Squamous cell and/or mixed small cell/non-small 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
*
This clinical trial is being conducted globally.
†
Olomorasib is administered PO.
‡
Pembrolizumab is administered intravenously (IV).
§
Pemetrexed is administered IV.
‖
Platinum (cisplatin or carboplatin) is administered IV.
¶
Placebo is administered PO.
