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

Related trial leads

A trial record is a lead only. The trial team must confirm whether it fits.

Phase 1/2 · completed

NCT03973151

Primary early clinical trial record for HL-085/tunlametinib in NRAS-mutant advanced melanoma.

This record is not the exact tunlametinib plus nivolumab combination remembered by the user.

Phase 3 · recruiting

NCT06008106

Phase III comparator trial after prior immunotherapy; useful for duration-of-response and trial-timing questions.

A trial listing match does not mean the trial fits. The trial team must confirm.

Phase 1/2 · unknown

NCT04375527

Supports the broader research concept of MEK inhibitor plus PD-1 inhibitor in melanoma, but not tunlametinib specifically.

Do not use this as evidence for tunlametinib plus nivolumab.

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.

This is belvarafenib/cobimetinib/nivolumab, not tunlametinib/nivolumab.

Related cohort threads

Sources with the medical details

  1. Tunlametinib Capsules approved with conditions for marketing by China NMPA. Accessed 2026-05-20.
  2. First-in-human phase I dose-escalation and dose-expansion trial of HL-085 in advanced melanoma harboring NRAS mutations. Accessed 2026-05-20.
  3. NCT03973151: Study of HL-085 in NRAS Mutant Advanced Melanoma. Accessed 2026-05-20.
  4. NCT06008106: Comparing Tunlametinib Capsules and Combination Chemotherapy in Advanced NRAS-mutant Melanoma. Accessed 2026-05-20.
  5. NCT04375527: Binimetinib and nivolumab in BRAF V600 wild-type melanoma. Accessed 2026-05-20.
  6. NCT04835805: Belvarafenib alone or with cobimetinib or cobimetinib plus nivolumab in NRAS-mutant advanced melanoma. Accessed 2026-05-20.