Clinical trial · Interventional
Radiotherapy Combined With Almonertinib for Stage III EGFR-Mutated Lung Cancer
Radiotherapy Combined With Almonertinib for Stage III EGFR-Mutated Lung Cancer：A Randomized Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Study Object: Stage III lung cancer with epidermal growth factor receptor (EGFR) sensitive mutation. Study Method: The study subjects will be randomly assigned to the intervention group and the control group. The intervention group will receive radiotherapy combined with erlotinib treatment, while the control group will receive concurrent radiotherapy combined with chemotherapy. The differences in short-term efficacy, long-term efficacy, and incidence of adverse reactions between the two groups will be observed. Observation Indicators: Short-term efficacy indicators: Complete remission (CR) rate, partial remission (PR) rate, and objective response rate (ORR). Long-term efficacy indicators: Overall survival (OS) and progression-free survival (PFS). Adverse reaction indicators: Incidence of lung toxicity, hematological toxicity, and gastrointestinal reactions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer Stage III | Malignant Lung Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Almonertinib | Drug | Aumolertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Radiotherapy Combined with Almonertinib
- description
- Radiotherapy was administered using Intensity-Modulated Radiation Therapy (IMRT) technique, with a prescribed dose of 60 Gy in 30 fractions. Almonertinib was orally administered at 110 mg per day, starting from the first day of radiotherapy and continued for 42 days until the completion of radiotherapy, followed by continuous medication until disease progression.
- interventionNames
- Drug: Almonertinib
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy Combined with Chemotherapy
- description
- Radiotherapy was administered using Intensity-Modulated Radiation Therapy (IMRT) technique, with a prescribed dose of 60 Gy in 30 fractions. Chemotherapy with paclitaxel at 135 mg/m2 and cisplatin at 70 mg/m2 was intravenously infused for two cycles during the 1st and 4th weeks. After the completion of radiotherapy, there was a rest period of 4 weeks, followed by continuation of the TP regimen for consolidation chemotherapy for 4 cycles.
- interventionNames
- Drug: Almonertinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients initially diagnosed with lung cancer through imaging and pathological examination.
* Genetic testing confirms EGFR-sensitive mutations.
* Staging according to the international eighth edition of lung cancer TNM is between stage ⅢA to ⅢC.
* Age between 18 to 80 years old, without severe organ diseases such as heart, liver, kidney, etc.
⑤ General condition assessed with a performance status (PS) score of ≤2 points.
Exclusion Criteria:
* ① Patients with upper gastrointestinal physiological disorders, malabsorption syndrome, intolerance to oral medications, or peptic ulcers.
* Patients who have received previous radiotherapy or chemotherapy for lung conditions.
* Patients with concomitant chronic obstructive pulmonary disease, atelectasis, or other conditions that cause difficulties in lesion measurements.
* Patients with active pulmonary tuberculosis. ⑤ Patients with respiratory failure. ⑥ Patients with allergies to the investigational drugs used in this study. ⑦ Pregnant or lactating women. ⑧ Patients with any other diseases, neurological or metabolic disorders, physical examination or laboratory findings that may raise reasonable suspicions of certain diseases or conditions, which would either disqualify the use of the investigational drugs or place the subjects at high risk of treatment-related complications.References
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