EGFR-TKI plus local consolidative SBRT versus EGFR-TKI alone for limited metastatic EGFR mutated non-small-cell lung cancer: a phase II randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800017811

Enrollment

Unknown

Registered

2018-08-16

Start date

2018-09-03

Completion date

Unknown

Last updated

2018-08-20

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

Interventions

A:local consolidative SBRT concurrent with EGFR-TKI

B:EGFR-TKI alone

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age = 18 years; 2. ECOG performance status of 0–2; 3. Histologically or cytologically proven non-small cell lung cancer with metastatic disease detected on imaging; 4. EGFR mutation tested positive by using tumor tissue or circulating tumor DNA; 5. The total number of metastases must be 5 or less; 6. At least 3 months after treated with EGFR-TKI, with no progress disease; 7. Life expectancy >6 months; 8. Willing to provide informed consent.

Exclusion criteria

Exclusion criteria: 1. Serious medical comorbidities precluding radiotherapy; 2. Prior radiotherapy to a site requiring treatment; 3. Complete response to target therapy (i.e. no measurable target for SBRT); 4. Malignant pleural or pericardial effusion; 5. Inability to treat all sites of active disease; 6. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Progression-free survival;	—

Secondary

Measure	Time frame
Acute and late toxicity;Lesional control rate;Overall Survival;	—

Countries

China

Contacts

Public ContactBuhong Zheng

Fujian Provincial Tumor Hospital

zhengbuhong@hotmail.com+86 13655031969

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026