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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
97
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.
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.
Shanghai Chest Hospital, Shanghai, Recruiting
Shanghai, China
Objective Response Rate (ORR)
The proportion of patients achieving complete remission (CR) or partial remission (PR)
Time frame: up to 7 weeks after standard subsequent-line therapy
Progression-free survival (PFS)
Time from randomization to disease progression or death
Time frame: up to 3 years
Overall survival (OS)
The time from random entry to death for any cause
Time frame: up to 3 years
Local Control (LC)
The time from the start of radiotherapy to any objectively recorded tumor progression at the irradiated site
Time frame: up to 3 years
Adverse Events (AE)
Number of participants with adverse events as assessed by CTCAE v5.0
Time frame: up to 3 years
local treatment tolerability
Number of participants with severe treatment--related adverse events as assessed by CTCAE v5.0 or who discontinue treatment
Time frame: up to 3 years
treatment failure pattern
The sites of disease progression post-treatment.
Time frame: up to 3 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.