NCT07076693

Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive Non-Small Cell Lung Cancer(NSCLC）

Standard-of-care Systemic Therapy With or Without Local Therapy in Patients With Oligoprogressive NSCLC: A Prospective, Randomized Controlled Phase II/III Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 97 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, controlled, phase II/III clinical study to evaluate the efficacy and safety of stand-of-care systemic therapy with local therapy versus stand-of-care systemic therapy in patients with oligoprogressive non-small cell lung cancer(NSCLC).

Detailed description

Subjects who meet all the inclusion criteria but do not meet any exclusion criteria are randomized into two groups at a ratio of 1:1: according to the stratification factors as below: * mutation status (known vs absent/unknown) * Number of oligoprogressive lesions (1-2 vs 3) Experimental group: For patients with oligoprogressive disease, local treatment (radiotherapy or surgery) is administered to all/partial oligoprogressive sites while providing standard systemic therapy for 4-6 cycles. Radiotherapy is administered with radiation dose 30-50Gy. The site and regimen of radiotherapy or surgery are primarily determined by the investigator. Maintenance therapy is determined by investigator assessment after evaluation. Control group: Standard systemic therapy is administered for 4-6 cycles . Maintenance therapy is determined by investigator assessment after evaluation. Adverse events (AEs) will be monitored throughout the study, and the severity will be graded to the guidelines listed in National Cancer Institute (NCI) common terminology criteria for adverse events (CTCAE) version 5.0 or above. The safety will be followed up in the subjects who have received study treatment and discontinued the drug prematurely. All the subjects will be followed up for overall survival, until death, withdrawal of informed consent or end of study.

Conditions

• OligoProgressive Metastatic Disease
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Radiotherapy or Surgery	Metastatic lesions were treated with surgical resection or radiotherapy. Surgical duration was determined by investigator assessment and metastatic or primary lesions were resected with palliative intent. Radiation dose and fractionation are 30\~50Gy. Radiation dose, fractionation regimen, and treatment sites for metastatic lesions were determined at the investigator's discretion based on clinical indications.
DRUG	Standard Medical Therapy	Patients with squamous cell carcinoma received docetaxel administered in 3-week cycles, and patients with adenocarcinoma received pemetrexed, patinum and one of sintilimab or ivonescimab.

Timeline

• Start date: 2025-06-03
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: China