NCT02940990

SBRT in Multi-metastatic NSCLC Patients Which Are Pan-negative for Driver Mutations

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Shanghai Chest Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol is a phase II multi-center randomized controlled trial (RCT) evaluating the efficacy of SBRT in multi-metastatic NSCLC patients who are pan-negative for driver mutations.

Detailed description

Lung cancer is the leading cause of cancer death. Forty percent of patients are diagnosed as metastatic lung cancer, and about 50% of them are pan-negative for driver mutations. The median overall survival(OS) for these patients is 11 months, and maintenance therapy can only prolong 2 months of OS. The NCCN guidelines recommend 4-6 cycles of chemotherapy with or without maintenance chemotherapy. Published data showed that radiotherapy modulates tumor phenotypes, enhances antigen presentation and tumor immunogenicity. The regression of out-field lesions was termed as "abscopal effect". The combination of radiotherapy with immunotherapeutic agents may promote the host anti-tumor immune response and increase the rate of abscopal effect.Published data showed that abscopal effect appeared in 20%-30% patients with metastatic malignant tumors who were treated with the combination of SBRT and GM-CSF. The investigators evaluate the efficacy of the combination of SBRT and GM-CSF in the multi-metastatic NSCLC participants who are pan-negative for driver mutations. Patients enrolled will be randomized into two groups. The control group will receive the standard regimen as NCCN recommends. The experimental group will receive both the standard chemotherapy and the extra SBRT to primary lesions or metastatic lesions combined with GM-CSF. The investigators compare progress free survival(PFS) of the two groups.

Conditions

• NSCLC
• SBRT
• GM-CSF

Interventions

Type	Name	Description
RADIATION	SBRT concurrent with GM-CSF	SBRT and GM-CSF 125ug/m2 for 14 days
DRUG	two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel	two-drug regimen

Timeline

• Start date: 2016-11-01
• Primary completion: 2019-12-01
• First posted: 2016-10-21
• Last updated: 2016-12-01

Locations

1 site across 1 country: China