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Trial Title:
Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy
NCT ID:
NCT06313541
Condition:
NSCLC Stage IV
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Immune Checkpoint Inhibitors
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
SBRT or LDRT
Description:
Radiotherapy: (1) Low dose radiotherapy (LDRT) : a dose of 2 Gy/1 Fx was given to all
visible lesions in the whole body within 1 week before the first course of PD-1/PD-L1
inhibitor combined with chemotherapy (different parts of the lesion could be irradiated
separately, but it was required to be completed within 1 week); (2) SBRT: patients
received first-line immunotherapy combined with chemotherapy, and their response was
evaluated every 6 weeks. Individualized SBRT was planned based on the treatment
responses.
Arm group label:
Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy
Intervention type:
Drug
Intervention name:
PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy
Description:
The control group received standard PD-1/PD-L1 inhibitor combined with platinum-based
chemotherapy as first-line treatment, and the experimental group received extra treatment
response adapted hybrid radiotherapy.
Arm group label:
PD-1/PD-L1 inhibitor combined with chemotherapy
Arm group label:
Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy
Summary:
This study is a multicenter, randomized controlled clinical trial to explore the
preliminary efficacy and safety of treatment response adapted hybrid radiotherapy (LDRT
and SBRT) in the first-line treatment of immunotherapy combined with chemotherapy for
advanced driver-gene negative NSCLC, and to provide new ideas for the comprehensive
treatment of advanced NSCLC
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ECOG functional status score was 0-1.
- Histologically confirmed stage IV primary NSCLC;
- Genetic testing showed that the common driver genes including EGFR, ALK and ROS-1
were negative;
- Patients with brain metastases were eligible if they were neurologically
asymptomatic and had stable disease without receiving systemic glucocorticoids;
- According to the investigator's judgment, the patient does not need to receive
palliative radiotherapy for any site at present;
- Male/female of childbearing age agreed to use contraception (surgical ligation or
oral contraceptive/intrauterine device plus condom) during the trial;
- Life expectancy ≥3 months;
- One week before enrollment, the organ function level met the following criteria:
① Bone marrow function: 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;
② Liver: serum total bilirubin level ≤1.5 times upper limit of normal, direct
bilirubin level must be ≤1.5 times upper limit of normal, aspartate aminotransferase
(AST) and alanine aminotransferase (ALT) ≤2.5 times upper limit of normal;
③ Kidney: serum creatinine < 1.5 times upper limit of normal or creatinine clearance
≥50ml/min, urea nitrogen ≤200mg/L; Serum albumin ≥30g/L;
- Patients must be able to understand and voluntarily sign the informed consent form.
Exclusion Criteria:
- The patient had severe autoimmune diseases: active inflammatory bowel disease
(including Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma,
systemic lupus erythematosus, autoimmune vasculitis (such as Wegener's
granulomatosis), etc.
- Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;
- Patients with risk factors for intestinal perforation: active diverticulitis,
intra-abdominal abscess, gastrointestinal (GI) obstruction, abdominal cancer, or
other known risk factors for intestinal perforation;
- History of other malignant tumors;
- Patients with active infection, heart failure, myocardial infarction, unstable
angina or unstable arrhythmia within the past 6 months;
- Medical examination or clinical findings, or other uncontrollable conditions that
the investigator considers may interfere with the results or increase the patient's
risk of treatment complications;
- Patients who were considered by the investigator to have lesions requiring
palliative and subtractive radiotherapy;
- Mixed with small cell lung cancer components;
- Lactating or pregnant women;
- Congenital or acquired immunodeficiency diseases including human immunodeficiency
virus (HIV), organ transplantation or allogeneic stem cell transplantation;
- Known HBV, HCV, active pulmonary tuberculosis infection;
- Patients had received a cancer vaccine or received another vaccine within 4 weeks
before starting treatment (note: injectable seasonal influenza vaccine is usually
inactivated, so vaccination is allowed, while intranasal vaccine is usually live
attenuated, so it is not allowed);
- Patients with concurrent use of other immune agents, chemotherapy drugs, drugs in
other clinical studies, and long-term use of cortisol were excluded.
- Patients with mental disorders, substance abuse, or social problems that affect
adherence were excluded from the study after physician review;
- Patients who are allergic to or contraindicated to PD-1 monoclonal antibody or
chemotherapy drugs.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengfei Zhu, MD
Phone:
+86-18017312901
Email:
fuscczzf@163.com
Contact backup:
Last name:
Jianjiao Ni, MD
Phone:
13761974092
Email:
nijianjiao8@sina.com
Start date:
April 10, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313541