SBRT Combined With PD-1 Inhibitor and Thoracic Hyperthermia for Advanced NSCLC

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    63
  • sponsor
    First People's Hospital of Hangzhou
Updated on 7 October 2022

Summary

The aim of this trial is to investigate the primary efficacy of SBRT combined with PD-1 inhibitor and thoracic hyperthermia in patients with EGFR, ALK, and ROS1 negative stage IV NSCLC patients who progressed after first-line treatment. At least one lesion (primary or metastatic) was selected for SBRT treatment, and the radiotherapy dose of each lesion was 32Gy/4Fx. SBRT was combined with thoracic hyperthermia from the first fraction, and hyperthermia was performed 6 times, twice a week. PD-1 inhibitor was used on the second day after the completion of SBRT. The PD-1 inhibitor was administered at a dose of 200mg every time, every 3 weeks for 2 years (35 times total), or until the investigators deem that the patient need to discontinue the drug because of treatment-related toxicity or disease progression. During the period, the overall response rate and toxicities were regularly evaluated.

Details
Condition Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC
Treatment SBRT combined with PD-1 inhibitors and thoracic hyperthermia
Clinical Study IdentifierNCT05520853
SponsorFirst People's Hospital of Hangzhou
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age≥18
ECOG PS 0-1
Histopathologically confirmed stage IV non-small-cell lung cancer
EGFR/ALK/ROS-1 negetive
Disease progression after first-line therapy including platinum chemotherapy, but not include PD-1/L1 inhibitors
Subjects with brain metastases were eligible, but only if they had no neurologic symptoms or disease stable without systemic glucocorticoid
At least one lesion with a diameter of 1-5cm which could be treated with SBRT at a dose of 32Gy/4Fx, and at least one lesion which could be measured other than SBRT (RECIST1.1); Lymph nodes can be used as independent measurable lesions or receive SBRT. Brain lesions should not be used as separate SBRT lesions or as measurable lesions
The subjects did not had radiotherapy before
The subjects did not currently need palliative radiotherapy at any part according to the researchers
It was necessary for the subjects who underwent surgery to fully recover from the toxicity and complications caused by surgical intervention prior to treatment
Subjects should provide appropriate biopsy specimens before and during treatment according to the clinical trial protocol
Male or female subjects agree to contraception during the trial (surgical ligation or oral contraceptive/IUD + condom)
Life expectancy ≥ 3 months
The organ function level meet the following standards one week before enrollment
①Bone marrow: hemoglobin ≥80g/L, white blood cell count ≥4.0 _10^9/L or
neutrophil count ≥1.5_ 10^9/L, platelet count ≥10010^9/L
②Liver: Serum total bilirubin level ≤1.5 upper limit of normal (ULN), when
serum total bilirubin level > 1.5 ULN, direct bilirubin level must be ≤ ULN
aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 ULN
③ Kidney: serum creatinine level < 1.5 ULN or creatinine clearance rate ≥
ml/min, urea nitrogen ≤ 200mg/L; Serum albumin ≥ 30g/L
\. Subjects must be able to understand and voluntarily sign informed consent

Exclusion Criteria

Prior treatment with anti-PD-1 /L1 drugs or other investigational immunotherapy agent
Subjects had prior radiotherapy
Subjects had severe autoimmune diseases: active inflammatory bowel disease (including Crohn's disease and ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's granuloma), etc
Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia
Subjects had risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other risk factors for bowel perforation
History of other malignant tumors
Subjects who have current infection, heart failure, heart attack, unstable angina, or unstable arrhythmia in the last 6 months
Subjects with physical examination or clinical trial findings, or other uncontrolled conditions that the investigator believes may interfere with the outcome or increase the risk of treatment complications
Subjects without platinum-based combination chemotherapy included as first-line treatment
The pathology reports showed a mixture of small cell lung cancer components
Lactating or pregnant women
Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or a history of organ transplantation, allogeneic stem cell transplantation
Known hepatitis B virus (HBV), hepatitis C virus (HCV), active pulmonary tuberculosis infections
Subjects had cancer vaccines other vaccines within 4 weeks before treatment initiation. (Seasonal influenza vaccines are usually inactivated and are permitted, whereas intranasal preparations are usually live attenuated vaccines and therefore are not permitted)
Subjects who currently use other immune agents, chemotherapy agents, other investigational drugs or long-term cortisol therapy
Subjects with mental illness, substance abuse, and social problems that affected compliance were not included in the study according to doctor's evaluation
Allergic or contraindicated to PD-1 inhibitors
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