Patient pathway
A China-specific treatment came up
A pathway for cross-border and country-specific drug conversations.
What this situation means
- Some drugs or protocols may be country-specific, conditionally approved, or institution-specific.
What not to assume
- Do not assume a China-approved medicine is available in the U.S., Korea, Japan, or EU.
Information to gather
- Chinese drug name
- English/generic name
- approval source
- trial/protocol link
- prescribing hospital
- combination partners
Bring to the surgeon
- Would travel or timing affect local procedures?
Bring to the oncologist
- Is this approved, trial-based, local protocol, compassionate access, or off-label?
- How will response duration be monitored?
Bring to the trial team
- Would this treatment affect whether later trials fit elsewhere?
Related database records
source-backed record
Tunlametinib / HL-085
Approved in some placessource-backed record
Tunlametinib + nivolumab unresolved lead
Lived experience onlyRelated trial leads
Phase 1/2 · completed
NCT03973151
Primary early clinical trial record for HL-085/tunlametinib in NRAS-mutant advanced melanoma.
Phase 3 · recruiting
NCT06008106
Phase III comparator trial after prior immunotherapy; useful for duration-of-response and trial-timing questions.
Phase 1/2 · unknown
NCT04375527
Supports the broader research concept of MEK inhibitor plus PD-1 inhibitor in melanoma, but not tunlametinib specifically.
Phase 1 · unknown
NCT04835805
A sourced NRAS melanoma trial lead after anti-PD-1/PD-L1 therapy that may explain a remembered MEK/RAF plus PD-1 trial concept.
Related cohort threads
lived experience only
Experiences with tunlametinib / HL-085 plus nivolumab after PD-1 failure
A cohort-style thread for families to describe what happened, what they asked, and what they wish they had known. Not a recommendation thread.
Sources with the medical details
- Tunlametinib Capsules approved with conditions for marketing by China NMPA. Accessed 2026-05-20.
- First-in-human phase I dose-escalation and dose-expansion trial of HL-085 in advanced melanoma harboring NRAS mutations. Accessed 2026-05-20.
- NCT03973151: Study of HL-085 in NRAS Mutant Advanced Melanoma. Accessed 2026-05-20.
- NCT06008106: Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma. Accessed 2026-05-20.
- NCT04375527: Binimetinib and nivolumab in BRAF V600 wild-type melanoma. Accessed 2026-05-20.
- NCT04835805: Belvarafenib alone or with cobimetinib or cobimetinib plus nivolumab in NRAS-mutant advanced melanoma. Accessed 2026-05-20.