An Open, Single-arm, Multicenter Phase II Trial to Evaluate SBRT Combined With PD-1 Inhibitors and Thoracic Hyperthermia for Advanced Non-Small-Cell Lung Cancer

First People's Hospital of Hangzhou1 site in 1 country63 target enrollmentJanuary 20, 2020

ConditionsStereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Stereotactic Body Radiation Therapy; PD-1 Inhibitor; Hyperthermia; NSCLC
Sponsor: First People's Hospital of Hangzhou
Enrollment: 63
Locations: 1
Primary Endpoint: Overall response rate
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

January 20, 2020

End Date

December 31, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

First People's Hospital of Hangzhou

Responsible Party

Principal Investigator

Bing Xia

Dr.

First People's Hospital of Hangzhou

Eligibility Criteria

Inclusion Criteria

•2.ECOG PS 0-
•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.

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.