Treatment Response Adapted Hybrid Radiotherapy in Metastatic Non-small Cell Lung Cancer Receiving First-line Immunotherapy

NCT ID: NCT06313541

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-10
• Study Completion Date: 2025-12-31

Brief 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

Conditions

NSCLC Stage IV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PD-1/PD-L1 inhibitor combined with chemotherapy

Group Type: ACTIVE_COMPARATOR

PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy

Intervention Type: DRUG

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.

Treatment response adapted hybrid radiotherapy plus PD-1/PD-L1 inhibitor and chemotherapy

Group Type: EXPERIMENTAL

SBRT or LDRT

Intervention Type: RADIATION

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.

PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy

Intervention Type: DRUG

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.

Interventions

SBRT or LDRT

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.

Intervention Type: RADIATION

PD-1/PD-L1 inhibitor combined with platinum-based chemotherapy

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhengfei Zhu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhengfei Zhu

Role: CONTACT

fuscczzf@163.com

+86-18017312901

Facility Contacts

Zhengfei Zhu, MD

Role: primary

fuscczzf@163.com

+86-18017312901

Jianjiao Ni, MD

Role: backup

nijianjiao8@sina.com

13761974092

Other Identifiers

2024-Lung-LDRT/SBRT

Identifier Type: -

Identifier Source: org_study_id