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Phase ? Clinical Trial of Local Consolidation Therapy Combined with First-line Immunochemotherapy for the Treatment of EGFR/ALK Mutation-Negative Non-Small Cell Lung Cancer with Oligo-metastatic Residual Lesions

Phase ? Clinical Trial of Local Consolidation Therapy Combined with First-line Immunochemotherapy for the Treatment of EGFR/ALK Mutation-Negative Non-Small Cell Lung Cancer with Oligo-metastatic Residual Lesions

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110791
Enrollment
Unknown
Registered
2025-10-21
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

no small cell lung cancer

Interventions

Test group:Local consolidation therapy combined with immunochemotherapy
Control group:first-line immunochemotherapy

Sponsors

Yueyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age>=18 years old; At the first visit, the pathological diagnosis was NSCLC (squamous cell carcinoma or adenocarcinoma, excluding other types of NSCLC), and the driver gene (EGFR/ALK) was negative; According to the 9th edition of the UICC TNM classification criteria, the stage is TxNxM1 (stage IV) (systematic evaluation methods include CT/MRI and/or PET-CT); 4. Immunochemotherapy is used as the initial treatment; 5. After first-line immunotherapy (21 days/cycle, a total of 3 cycles), if the ORD criteria (metastatic lesions=90 g/L (no blood transfusion within 14 days); Ii. Neutrophil count>1.5 × 10 ^ 9/L; iii Platelet count>=100 × 10 ^ 9/L; b) Biochemical examination: i. Total bilirubin=60ml/min (Cockcroft Gault formula); c) Cardiac Doppler ultrasound evaluation: Left ventricular ejection fraction (LVEF)>=50%; d) Blood glucose should be controlled at fasting blood glucose<7.2 mmol/L, non fasting blood glucose<10 mmol/L, and glycated hemoglobin<7%. 8. Sign the informed consent form; 9. Good compliance, family members agree to cooperate in receiving survival follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with abnormal coagulation function and bleeding tendency (must meet the requirement of INR being within the normal range without using anticoagulants within 14 days before randomization); Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogues; Under the premise that the international normalized ratio (INR) of prothrombin time is less than 1.5, it is allowed to use low-dose warfarin (1mg orally, once daily) or low-dose aspirin (daily dose not exceeding 100 mg) for preventive purposes; 2. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders; 3. Screening for arterial/venous thrombosis events that have occurred within the previous 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis (excluding those caused by venous catheterization during previous chemotherapy and judged to have recovered by researchers), and pulmonary embolism; 4. Contraindications for immunotherapy, radiotherapy, and puncture; 5. According to the researcher's judgment, there are accompanying diseases that seriously endanger patient safety or affect the completion of the study.

Design outcomes

Primary

MeasureTime frame
Overall survival (OS);

Secondary

MeasureTime frame
progression-free survival (PFS);time to progression(TTP);

Countries

China

Contacts

Public ContactXie Wangti

Yueyang Central Hospital

xiewangti@163.com+86 187 7300 6437

Outcome results

None listed

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