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

NCT ID: NCT05520853

Condition: Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC

Conditions: Official terms:
Hyperthermia
Fever
Immune Checkpoint Inhibitors

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: SBRT combined with PD-1 inhibitors and thoracic hyperthermia
Description: 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.
Arm group label: SBRT combined with PD-1 inhibitors and thoracic hyperthermia

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1.Age≥18. - 2.ECOG PS 0-1. - 3.Histopathologically confirmed stage IV non-small-cell lung cancer. - 4.EGFR/ALK/ROS-1 negetive. - 5.Disease progression after first-line therapy including platinum chemotherapy, but not include PD-1/L1 inhibitors. - 6.Subjects with brain metastases were eligible, but only if they had no neurologic symptoms or disease stable without systemic glucocorticoid. - 7.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. - 8.The subjects did not had radiotherapy before. - 9.The subjects did not currently need palliative radiotherapy at any part according to the researchers. - 10.It was necessary for the subjects who underwent surgery to fully recover from the toxicity and complications caused by surgical intervention prior to treatment. - 11.Subjects should provide appropriate biopsy specimens before and during treatment according to the clinical trial protocol. - 12.Male or female subjects agree to contraception during the trial (surgical ligation or oral contraceptive/IUD + condom). - 13.Life expectancy ≥ 3 months. - 14.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 ≥100*10^9/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 ≥ 50ml/min, urea nitrogen ≤ 200mg/L; Serum albumin ≥ 30g/L. - 15. Subjects must be able to understand and voluntarily sign informed consent. Exclusion Criteria: - 1.Prior treatment with anti-PD-1 /L1 drugs or other investigational immunotherapy agent. - 2.Subjects had prior radiotherapy. - 3.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. - 4.Symptomatic interstitial lung disease or active infectious/noninfectious pneumonia. - 5.Subjects had risk factors for bowel perforation: active diverticulitis, intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or other risk factors for bowel perforation. - 6.History of other malignant tumors. - 7.Subjects who have current infection, heart failure, heart attack, unstable angina, or unstable arrhythmia in the last 6 months. - 8.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. - 9.Subjects without platinum-based combination chemotherapy included as first-line treatment. - 10.The pathology reports showed a mixture of small cell lung cancer components. - 11.Lactating or pregnant women. - 12.Congenital or acquired immunodeficiency diseases including human immunodeficiency virus (HIV), or a history of organ transplantation, allogeneic stem cell transplantation. - 13.Known hepatitis B virus (HBV), hepatitis C virus (HCV), active pulmonary tuberculosis infections. - 14.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) - 15.Subjects who currently use other immune agents, chemotherapy agents, other investigational drugs or long-term cortisol therapy. - 16.Subjects with mental illness, substance abuse, and social problems that affected compliance were not included in the study according to doctor's evaluation. - 17.Allergic or contraindicated to PD-1 inhibitors.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Affiliated Hangzhou Cancer Hospital, Zhejiang University School of Medicine

Address:
City: Hangzhou
Zip: 310002
Country: China

Status: Recruiting

Contact:
Last name: Bing Xia, MD

Phone: 86-0571-56006382
Email: bxia_hzch@hotmail.com

Start date: January 20, 2020

Completion date: December 31, 2024

Lead sponsor:
Agency: First People's Hospital of Hangzhou
Agency class: Other

Collaborator:
Agency: Hangzhou Cancer Hospital
Agency class: Other

Source: First People's Hospital of Hangzhou

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05520853

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