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The safety and efficiency of SRS and almonertinib combination for the treatment of brain oligometastatic in non-small cell lung cancer (NSCLC) patients with EGFR mutation: a single-arm, open-label, single-center phase II study

The safety and efficiency of SRS and almonertinib combination for the treatment of brain oligometastatic in non-small cell lung cancer (NSCLC) patients with EGFR mutation: a single-arm, open-label, single-center phase II study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043666
Enrollment
Unknown
Registered
2021-02-26
Start date
2021-03-01
Completion date
Unknown
Last updated
2021-06-22

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

1:SRS and almonertinib combination

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Non-small cell lung cancer with EGFR mutations proved by pathological examinations; 2. the brain metastatic sites are less than 5 proved by CT or MRI examinations, or the brain metastatic is stable after treatment with the first/second generation EGFR-TKIs, or the brain metastatic sites are less than 5 after treatment with the first/second generation EGFR-TKIs; 3. after receiving systemic treatment, the primary and metastatic tumors are stable and no new progress shows at least 2 weeks; 4. all the oligometastatic sites should be suitable for SRS treatment.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with other kind of cancers at the same time; 2. The primary and metastatic tumors have been irradiated; 3. Pregnant or breast-feeding female patients; 4. The tumor boundary could not be defined; 5. Patients with respiratory failure; 6. Patients and their caregivers refused to participate; 7. Patients with severe inflammation or other serious diseases; 8. Allergic to the study drugs; 9. Patients who has been involved in other clinic trails; 10. Patients defined as not suitable by the researchers.

Design outcomes

Primary

MeasureTime frame
Five-year disease-free survival;intracranial progression-free survival (iPFS);

Secondary

MeasureTime frame
Objective response rate (ORR);Overall survival (OS);progression-free survival (PFS);

Countries

China

Contacts

Public ContactHe chunyu

Henan Cancer Hospital

15003883759@163.com+86 15003883987

Outcome results

None listed

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