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Phase II Single-Arm Clinical Study of Stereotactic Radiotherapy Combined with Low-Dose Radiotherapy to the Gut, PD-1 Inhibitor, and Bevacizumab in Second-Line or Higher Treatment of Driver Gene-Negative Advanced Non-Small Cell Lung Cancer?

Phase II Single-Arm Clinical Study of Stereotactic Radiotherapy Combined with Low-Dose Radiotherapy to the Gut, PD-1 Inhibitor, and Bevacizumab in Second-Line or Higher Treatment of Driver Gene-Negative Advanced Non-Small Cell Lung Cancer?

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123755
Enrollment
Unknown
Registered
2026-04-29
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

Lung cancer

Interventions

experimental group:SBRT + ILDR + Immunotherapy + Anti-angiogenic Therapy?

Sponsors

Shenshan Medical Centre, Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years, regardless of gender. 2. ECOG performance status =12 weeks. 4. Histologically or cytologically confirmed driver gene-negative lung adenocarcinoma with recurrent/metastatic disease, progressing after at least one prior NCCN guideline-recommended first-line therapy. 5. At least one lesion suitable for SABR and one measurable lesion per RECIST v1.1 (distinct from the SABR target), with no overlap between SABR and ILDR irradiation fields. 6. Not a candidate for curative surgery. 7. Adequate organ and bone marrow function. 8. Signed informed consent, with willingness to comply with study procedures, laboratory tests, and follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to radiotherapy or immunotherapy. 2. Patients with histologically or cytologically confirmed small cell lung cancer or squamous cell lung carcinoma. 3. Patients with EGFR/ALK/ROS-1 mutations or unknown mutation status. 4. Patients who previously experienced grade >=3 immune-related adverse events (irAEs) per NCI-CTCAE v5.0 criteria. 5. Patients with unresolved toxicities from prior therapies (>CTCAE v5.0 grade 1). 6. Patients assessed as having hyperprogressive disease (HPD). 7. Patients who received pelvic or abdominal radiotherapy within 6 months prior to enrollment. 8. Patients who received systemic corticosteroids or other systemic immunosuppressive medications. 9. Patients with significant gastrointestinal disorders. 10. Patients with other severe comorbidities. 11. Patients with significant organ dysfunction or uncontrolled comorbidities. 12. Pregnant or lactating women, or fertile patients unwilling to use contraception. 13. Patients who refuse or are unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
objective response rate, ORR;—

Secondary

MeasureTime frame
Disease control rate, DCR;—

Countries

China

Contacts

Public ContactZhao xiaohui

Shenshan Medical Centre, Memorial Hospital of Sun Yat-Sen University

zhaoxh27@mail.sysu.edu.cn+86 138 2849 1190

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026