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LY2875358 · 4 trials · 5 indications
| Arm | Type | Description |
|---|---|---|
| LY2875358 plus Erlotinib | EXPERIMENTAL | Lead In: Approximately 8 weeks of erlotinib 150 milligram (mg) given orally per day. Randomization: Erlotinib 150 mg given orally per day plus 750 mg LY2875358 given as 1.5 hours intravenous (IV) infusions on Days 1 and 15 of 28-day cycles. |
| Erlotinib | ACTIVE_COMPARATOR | Lead In: Approximately 8 weeks of erlotinib 150 mg given orally per day. Randomization: Continue Erlotinib 150 mg given orally per day, in 28-day cycles. |
| LY2875358 | EXPERIMENTAL | LY2875358 will be administered intravenously (IV) at 2000 milligram (mg) bi-weekly in 28 day Cycle. |
| LY2875358+Erlotinib | EXPERIMENTAL | Part B1. Erlotinib will be administered orally at 150 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B1 was added per protocol amendment in January, 2013.) |
| LY2875358+Gefitinib | EXPERIMENTAL | Part B2. Gefitinib will be administered orally at 250 mg dose level each day. LY2875358 will be administered intravenously (IV) at recommended dose level in Part A on Day 1 and Day 15 of a 28-day cycle. (Part B2 was added per protocol amendment in January, 2013.) |
| LY2875358 + erlotinib | EXPERIMENTAL | - |
| LY2875358 at Part A highest dose | EXPERIMENTAL | - |
| LY2875358 at Part A highest dose + trametinib | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| LY2875358 | BIOLOGICAL | Administered IV |
| Erlotinib | DRUG | Administered Orally |
| Gefitinib | DRUG | Administered orally |
| LY2875358 + erlotinib | DRUG | Part A2 Dose escalation of LY2875358 administered IV, on Day 1 and 15 every 28 days for at least two cycles in combination with daily erlotinib dosing (150 mg) taken orally (PO). |
| LY2875358 at Part A highest dose | DRUG | Part B (Dose Exploration): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles. |
| LY2875358 at Part A highest dose + trametinib | DRUG | Part B (in combination with trametinib): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles, in combination with trametinib at 2 mg orally once daily |
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of metastatic Stage IV NSCLC * Have at least 1 measurable lesion whose presence is assessable using standard techniques by Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) * Have molecular evidence of an epid...
LY2875358 is an investigational small molecule being studied for the treatment of advanced cancer, solid tumors, carcinoma, non-small-cell lung cancer, and gastric cancer. It has been evaluated in clinical trials for these oncology indications.
LY2875358 is being developed by Eli Lilly and Company, a biopharmaceutical company listed on the stock exchange under the ticker symbol LLY. The drug is in clinical development for multiple oncology indications.
LY2875358 has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug and remains in clinical development. The drug has not been approved by regulatory authorities.
LY2875358 has been studied in several clinical trials, including NCT01287546 for advanced cancer, NCT01602289 for solid tumors and lymphoma in Japanese participants, NCT01874938 for MET positive advanced gastric cancer, and NCT01897480 for non-small cell lung cancer with EGFR mutations.
LY2875358 is the primary name used for this drug in clinical trials. No alternative names have been reported for this investigational agent.