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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
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| Group B | Experimental |
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| Group C | Experimental |
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| Group D | Experimental |
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| Group E | Experimental |
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| Group F | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Benmelstobart combined with chemotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The remission rate of abscopal lesions | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | 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 | 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 |
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Inclusion Criteria:
Patient must meet all of the following inclusion criteria to be enrolled in this study:
Exclusion Criteria:
Patients with any of the following criteria are not eligible for enrollment in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianguo Sun, MD | Contact | 86-13983155736 | sunjg09@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianguo Sun, MD | the second affiliated hospital of Army medical university, Chongqing, Chongqing 40037 Recruiting | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the second affiliated hospital of Army medical university | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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| Benmelstobart combined with chemotherapy | Drug | After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy * 15 fractions plus Benmelstobart. |
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| Benmelstobart combined with chemotherapy | Drug | After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart. |
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| Benmelstobart combined with chemotherapy | Drug | After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy * 16 * 6 fractions) plus Benmelstobart. |
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| Benmelstobart combined with chemotherapy | Drug | After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment. |
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| Benmelstobart combined with Bevacizumab and chemotherapy | Drug | 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. |
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| OS | 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 | up to 5 years |
| AE | The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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