SRT Combined With Envafolimab and Endostar in the First-line Treatment of Advanced NSCLC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First People's Hospital of Lianyungang
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects voluntarily participate in this study, sign the written informed consent form, and demonstrate good compliance.
Aged 18-80 years old at the time of signing informed consent, male or female.
Histologically confirmed stage IV non-small-cell lung cancer (NSCLC) according to the 8th IASLC/AJCC TNM staging system, with negative actionable driver gene alterations (EGFR/ALK/ROS1), and no prior systemic anti-cancer treatment.
Provide archived tumor tissue samples or newly obtained core/excisional biopsy specimens from tumor lesions which have not received prior anti-tumor therapy or radiotherapy. Formalin-fixed paraffin-embedded (FFPE) tissue blocks are preferred over slides; newly-obtained biopsy samples are preferred over archived tissues. PD-L1 expression ≥1% is confirmed by immunohistochemistry. For subjects without newly-obtained tissue, 5-8 slices of 3-5 μm paraffin sections of archived tissue collected within 2 years before enrollment are acceptable.
Disqualifiers
Tumor invades major blood vessels on CT/MRI, or judged to carry high risk of invading critical vessels and causing fatal hemorrhage during study treatment.
Currently participating in another interventional clinical trial, or received investigational drug/device within 4 weeks before first study drug administration.
Received anti-tumor Chinese patent medicine or immunomodulatory agents (such as thymosin, interferon, interleukin) within 2 weeks prior to first dose; or underwent major surgical operation within 3 weeks before first dose.
Active hemoptysis requiring clinical intervention, active diverticulitis, intra-abdominal abscess, gastrointestinal obstruction, or peritoneal metastasis.
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic Radiation Therapy
RadiationStereotactic 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.
Envafolimab
Drug300 mg administered by subcutaneous injection on Day 1 of each 3-week treatment cycle, initiated within 1-7 days after completion of radiotherapy.
Endostar
Drug210 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.
Treatment groups
61 Participants
are divided into 1 treatment groupGroup A: SRT + Envafolimab + EndostarExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
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 weeks2
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 treatmentSecondary outcomes
1
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 months2
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 months3
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 weeks4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov
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