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NCT07314216
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary Adenocarcinoma
Phase 2 trial testing Firmonertinib in NSCLC (Non-small Cell Lung Carcinoma) in 15 participants. Not yet recruiting.
31 December 2030
Quick facts
| Lead sponsor | Hunan Cancer Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 1 January 2026 |
| Primary completion | 31 December 2030 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- Firmonertinib — full drug profile →
- Definitive Thoracic Radiotherapy
Conditions studied
- NSCLC (Non-small Cell Lung Carcinoma) — all drugs for NSCLC (Non-small Cell Lung Carcinoma) →
- Stage III — all drugs for Stage III →
- EGFR Uncommon Mutations — all drugs for EGFR Uncommon Mutations →
Sponsor
Hunan Cancer Hospital
Who can join
Adults 18 to 75, any sex, with NSCLC (Non-small Cell Lung Carcinoma) or Stage III. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective, single-arm, Phase II clinical study aimed at evaluating the efficacy and safety of 160mg fimonertinib in combination with definitive radiotherapy for patients with EGFR uncommon driver mutation-positive, Stage III unresectable lung adenocarcinoma. The primary endpoint is Progression-Free Survival (PFS), assessed by the investigator according to RECIST 1.1 criteria, defined as the time from the first dose to objective disease progression or death (from any cause). Secondary endpoints include PFS by different mutation types, OS, ORR, DCR, as well as adverse events and their severity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07314216
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Firmonertinib
Trials testing the same drug.
- NCT07010419 — A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With St · Phase 3 · recruiting
- NCT07092202 — Firmonertinib Combined With Intrathecal Injection for the Treatment of EGFR Mutant NSCLC With Leptomeningeal Metastases · Phase 4 · recruiting
- NCT07239102 — Firmonertinib in the Treatment of EGFR(+) NSCLC Patients With Central Nervous System Metastasis · completed
Other recruiting trials for NSCLC (Non-small Cell Lung Carcinoma)
Currently open trials in the same condition.
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- NCT06881784 — Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301) · Phase 3 · recruiting
- NCT06685718 — A Study Investigating BG-60366 in Adults With Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer · Phase 1 · active not recruiting
Other Hunan Cancer Hospital trials
Trials by the same sponsor.
- NCT07083687 — Lorlatinib in ROS1+ NSCLC With Brain Metastasis · Phase 2 · not yet recruiting
- NCT07098026 — Shenqi Fuwei Mixture Combined With Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric Cancer · NA · recruiting
- NCT06840704 — Immunonutrition Reduces Acute Esophagitis After Thoracic Radiotherapy in Lung Cancer · Phase 3 · recruiting
- NCT06788002 — LDRT and Chemoimmunotherapy in NPC With Liver Metastasis · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07314216 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Hunan Cancer Hospital
- Last refreshed: 6 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07314216.
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