Clinical trial · Interventional
Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer
Aumolertinib Versus Osimertinib As First-line Therapy for Patients with EGFR Mutated Locally Advanced or Metastatic Non-small-cell Lung Cancer: a Randomized, Open-label, Non-inferiority Real World Study
- 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)
This is a multicenter, randomized, open-label, non-inferiority real world study. The study is designed to evaluate the efficacy and safety of Aumolertinib versus Osimertinib in the first-line treatment of patients with EGFR mutated locally advanced or metastatic non-small-cell lung cancer.
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aumolertinib | Drug | Aumolertinib | ALIAS |
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Aumolertinib
- interventionNames
- Drug: Aumolertinib
- type
- ACTIVE_COMPARATOR
- label
- Osimertinib
- interventionNames
- Drug: Osimertinib
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) as Assessed by Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- timeFrame
- Up to 3 years
- description
- PFS is defined as the time from date of randomization until date of disease progression or death due to any cause, whichever occurs first.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. At least 18 years old. 2. Participants voluntarily signed an informed consent form prior to participation. 3. The Eastern Cooperative Oncology Group (ECOG) physical status score of 0 or 1, no deterioration for at least 1 week before treatment, and the expected survival period is no less than 12 weeks. 4. Histologically or cytologically confirmed stage IIIB-IV NSCLC (according to the AJCC eighth edition lung cancer staging criteria), metastatic or recurrent lung cancer that is not amenable to curative intent therapy. 5. Positive EGFR mutation confirmed by tissue or cytology(including peripheral blood, pleural effusion, ascites, cerebrospinal fluid) with at least one sensitizing mutation (L858R or 19Del). 6. No prior systemic therapy was allowed, except in the adjuvant or neoadjuvant setting, and no progression was allowed within 6 months. 7. According to RECIST1.1, the patient must have at least one target lung lesion. The requirements for target lesions are: measurable lesions that have not undergone local treatment such as radiation, with the longest diameter at baseline ≥10 mm (if it is a lymph node, the maximum short diameter must be ≥15 mm). Exclusion Criteria: 1. Diagnosis of meningeal metastasis by clinical symptoms or imaging or cerebrospinal fl-uid, or brain parenchymal metastasis combined with meningeal metastasis. 2. History of other primary malignant tumors. 3. Hypersensitivity or allergy to aumolertinib or osimertinib or their excipients. 4. Female subjects who are pregnant, lactating, or planning to become pregnant during the treatment period. 5. The investigator assesses whether there are any patients with conditions that may compromise patient safety or interfere with the evaluation of the study, such as poorly controlled hypertension, active bleeding.
References
Publications (0)
Data not yet available