Drug · Small Molecule
Firmonertinib
CI-DRUG-00000247Explore in graph →NCIt C180535 CHEMBL4297258 CIViC Phase 3
Regulatory
Approvals (0)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
Data not yet available
No regulatory approval recorded. Absence here is not evidence of absence: only ingested jurisdictions are covered.
What CancerIndex knows
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Phase4 | Phase 4 | 33 | 21 | 6 | 49 | 0 | — | — | Dec 30, 2016 |
| Malignant Lung Neoplasm | Phase4 | Phase 4 | 31 | 20 | 5 | 44 | 0 | — | — | Dec 30, 2016 |
| Malignant Central Nervous System Neoplasm | Phase4 | Phase 4 | 2 | 2 | 0 | 3 | 0 | — | — | Jan 1, 2024 |
Computedclinicaltrials
Curated evidence
Clinical evidence (2)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
civicProvenance
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 40963567
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| EGFR H835L + EGFR L833V1 | ||||||||
| Firmonertinib | Lung Adenocarcinoma | |||||||
Clinical trials
Trials with this intervention (52)
Most recently updated first, 50 per page.
clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT07622186 | A Study of SKB571 Combination Therapy in Participants With Non-Small Cell Lung Cancer (NSCLC) | recruiting | Phase 2 | 150 | Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.INDUSTRY | 1 | Sep 2, 2026 | clinicaltrials |
| NCT07185997 | Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations |