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The application of osimertinib in early stage combined with stereotactic radiotherapy in EGFR-mutant stage IV oligo-residual non-small cell lung cancer

Phase I clinical study of osimertinib combined with stereotactic radiotherapy in early stage IV EGFR-mutant non-small cell lung cancer

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053807
Enrollment
Unknown
Registered
2021-11-29
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

non-small cell lung cancer (NSCLC)

Interventions

group 1:stereotactic body radiation therapy

Sponsors

Union Hospital Affiliated to Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. ECOG 0-1 points; 3. Metastatic NSCLC with positive EGFR sensitive mutation; 4. After osimertinib treatment, when the efficacy is maximized by CT follow-up diagnosis, the tumor is in oligo-residual state, and SBRT treatment is feasible according to the evaluation of radiotherapy experts; 5. SBRT indications are as follows: (1) <= 3 residual metastatic organs and <=5 residual metastatic lesions; (2) Extracranial metastases are limited to the lung, neck, mediastinum, abdominal and pelvic lymph nodes, adrenal glands, liver, bone, and spine; (3) No more than 3 brain metastases; (4) The maximum diameter of residual lung lesions is <= 6cm.

Exclusion criteria

Exclusion criteria: 1. Stage IV NSCLC with newly diagnosed meningeal metastasis, malignant pleural effusion and bone marrow metastasis; 2. EGFR exon 20 mutation, excluding sensitive mutations such as p.A763_Y764 insFQEA; 3. Patients with progression before radiotherapy after osimertinib treatment; 4. Patients with interstitial pneumonia after osimertinib treatment (regardless of grade); 5. Have a history of interstitial lung disease; 6. Combined with other non-tumor-related diseases such as severe cardiopulmonary diseases and uncontrolled infectious diseases, the patient cannot tolerate comprehensive treatment such as radiotherapy and chemotherapy.

Design outcomes

Primary

MeasureTime frame
Dose limiting toxicity;Adverse and serious adverse events;

Countries

China

Contacts

Public ContactXu Benhua

Union Hospital Affiliated to Fujian Medical University

benhuaxu@163.com+86 13365910602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026