NSCLC Stage IV Without EGFR/ALK Mutation
Conditions
Brief summary
This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with multiple metastases when different radiotherapy fractionation patterns are combined with Benmelstobart.
Interventions
After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.
DRUGBenmelstobart combined with Bevacizumab and chemotherapy
For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.
Sponsors
Xinqiao Hospital of Chongqing
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patient must meet all of the following inclusion criteria to be enrolled in this study: 1. Non-small cell lung cancer confirmed by pathological histology. 2. More than 3 metastatic lesions. 3. No brain metastases or stable lesions. 4. Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET). 5. Performance status (PS) score of 0-1, with an expected survival period of more than 3 months. 6. Age between 18 and 75 years old. 7. Assessment by PET-CT (including FDG and FMISO, not mandatory). 8. No contraindications to immunotherapy and radiotherapy. 9. Signed the informed consent form.
Exclusion criteria
* Patients with any of the following criteria are not eligible for enrollment in this study: 1. Those with severe dysfunction of important vital organs (heart, liver, kidney). 2. Those accompanied by other malignant tumors. 3. Uncontrolled heart diseases or myocardial infarction within the past 6 months. 4. Those with a history of mental illness. 5. Other situations in which the researcher deems it inappropriate for the subject to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The remission rate of abscopal lesions | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years | To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years | To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by progression-free survival rate according to RECIST v1.1 |
| OS | up to 5 years | To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by by overall survival |
| AE | From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years | The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Countries
China
Contacts
Primary ContactJianguo Sun, MD
Outcome results
None listed