This is a prospective, single-arm phase II clinical study. It intends to evaluate the efficacy and safety of stereotactic radiation therapy (SRT) combined with envafolimab and endostar as first-line treatment in stage IV non-small cell lung cancer (NSCLC) patients without actionable EGFR/ALK/ROS1 driver gene alterations and with PD-L1 TPS ≥ 1%. A total of 61 eligible participants will receive combination treatment of stereotactic radiotherapy, envafolimab and endostar. Tumor response will be evaluated every 6 weeks according to RECIST v1.1, and treatment-related adverse events will be monitored based on NCI-CTCAE v5.0. The treatment will continue until disease progression, patient withdrawal, loss of follow-up or death.
This prospective multi-center single-arm phase II trial focuses on unresectable stage IV NSCLC patients with negative driver genes and positive PD-L1 expression (TPS ≥1%). Eligible subjects are treatment-naive patients or recurrent cases after adjuvant chemotherapy. Patients will receive stereotactic body radiation therapy targeting 1 to 5 metastatic lesions with a dose of 30-50 Gy in 5-10 fractions. Within 1 to 7 days after radiotherapy, patients will receive 300 mg envafolimab subcutaneously on day 1 and 210 mg endostar continuous intravenous pumping on days 1-3 of each 3-week cycle. The overall clinical efficacy and safety profiles of this combined regimen will be systematically observed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Stereotactic radiotherapy delivered to 1-5 metastatic lesions, with a total dose of 30-50 Gy in 5-10 fractions. Lesions are selected based on larger volume, symptomatic status, or visceral location; treatment of all metastatic lesions is not required.
300 mg administered by subcutaneous injection on Day 1 of each 3-week treatment cycle, initiated within 1-7 days after completion of radiotherapy.
210 mg administered by continuous intravenous pumping on Days 1-3 of each 3-week treatment cycle, initiated within 1-7 days after completion of radiotherapy.
Lianyungang First People's Hospital
Lianyungang, China
Objective Response Rate (ORR)
Percentage of participants achieving complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST version 1.1. CR and PR must be confirmed by subsequent tumor assessment during the study.
Time frame: From treatment initiation up to 24 weeks
Incidence of Treatment-Related Adverse Events
Number and severity of treatment-related adverse events, laboratory abnormalities, vital sign and electrocardiogram changes, evaluated according to NCI-CTCAE version 5.0. Safety analyses will be performed in the safety set.
Time frame: From first study treatment to 90 days after last study treatment
Progression-Free Survival (PFS)
Time from treatment initiation to first documented radiological disease progression (per RECIST v1.1, investigator-assessed) or death from any cause, whichever occurs first. Participants without progression or death will be censored at the date of last valid tumor assessment.
Time frame: From treatment start until progression or death, up to 36 months
Overall Survival (OS)
Time from treatment initiation to death due to any cause.
Time frame: From treatment start until death from any cause, up to 48 months
Disease Control Rate (DCR)
Percentage of participants achieving complete response (CR), partial response (PR), or stable disease (SD), as assessed by the investigator according to RECIST version 1.1.
Time frame: From treatment initiation up to 24 weeks
Duration Of Response (DOR)
Time interval from the first documented objective tumor response until disease progression or death from any cause, whichever occurs first.
Time frame: From first confirmed response until progression or death, up to 36 months
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