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

NCT02940990 | Unknown Phase 2 DMC

• 1 other identifier: SCHLC007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC; SBRT; GM-CSF

Outcome Measures

Primary Outcomes (1)

• Progress Free Survival (PFS)

  2 years

Secondary Outcomes (2)

• Overall Survival （OS）

  2 years

• Incidence of treatment-related adverse events

  2 years

Study Arms (2)

Group A

PLACEBO COMPARATOR

Participants in the Group A will receive 4-6 cycles of standard two-drug chemotherapy. After that, clinical observation or maintenance chemotherapy will be given.

Drug: two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel

Group B

EXPERIMENTAL

Participants in the Group B will also receive 4-6 cycles of standard two-drug chemotherapy. However, they will receive an additional treatment of SBRT to primary lesions or metastatic lesions combined with GM-CSF.

Radiation: SBRT concurrent with GM-CSF; Drug: two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel

Interventions

SBRT concurrent with GM-CSF RADIATION

SBRT and GM-CSF 125ug/m2 for 14 days

Group B

two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel DRUG

two-drug regimen

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven non-small-cell lung cancer.
• Stage IV according to UICC stage system(version 7,2009).The number of metastatic lesions\>5
• Pan-negative for driver mutations including EGFR ALK ROS1 c-MET
• At least Three evaluable lesions among which at least two must be suitable for SBRT.
• ECOG performance status 0-2.
• Expected lifespan ≥3 months.
• No brain metastasis in MRI.
• No liver metastasis in abdominal CT or MRI.
• No malignant pleural effusion or pericardial effusion from chest CT and/or pathology.
• Stable lab values: Hematological:
• Absolute neutrophil count (ANC) ≥1.5×109/L, Platelets ≥100×109/L, Hemoglobin ≥9 g/dL Renal: Creatinine OR Measured or calculated creatinine clearance (CrCl) (glomerular filtration rate \[GFR\] can also be used in place of creatinine or CrCl) ≤1.5× the upper limit of normal (ULN) OR ≥60 mL/min for patient with creatinine levels \>1.5× institutional ULN Hepatic: Total bilirubin ≤1.5×ULN OR Direct bilirubin ≤ULN for patients with total bilirubin levels \>1.5×ULN, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN OR ≤5×ULN for patients with liver metastases ,globulin≥20 g/L, albumin≥30 g/L.
• \- Able to understand and give written informed consent and comply with study procedures.

You may not qualify if:

• Any unstable systemic disease, including active infection, uncontrolled high blood pressure, unstable angina, newly observed angina pectoris within the past 3 months, congestive heart failure (New York heart association (NYHA) class II or higher), myocardial infarction onset six months before included into the group, and severe arrhythmia, liver, kidney, or metabolic disease in need of drug therapy.
• Previously diagnosed with immunodeficiency disease.
• Human immunodeficiency virus (HIV) infection.
• Women in pregnancy or lactation .
• Patients with mental illness, considered as "can't fully understand the issues of this research".
• other Cancer history.
• Histologically confirmed small cell carcinoma or other non NSCLC compositions in the cancer tissue.
• Brain metastasis or liver metastasis or malignant pleural effusion or pericardial effusion.
• Allergy of rhGM-CSF and its accessories.
• Contraindications to GM-CSF treatment.

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

• Golden EB, Chhabra A, Chachoua A, Adams S, Donach M, Fenton-Kerimian M, Friedman K, Ponzo F, Babb JS, Goldberg J, Demaria S, Formenti SC. Local radiotherapy and granulocyte-macrophage colony-stimulating factor to generate abscopal responses in patients with metastatic solid tumours: a proof-of-principle trial. Lancet Oncol. 2015 Jul;16(7):795-803. doi: 10.1016/S1470-2045(15)00054-6. Epub 2015 Jun 18.

  PMID: 26095785 RESULT

• Bernstein MB, Krishnan S, Hodge JW, Chang JY. Immunotherapy and stereotactic ablative radiotherapy (ISABR): a curative approach? Nat Rev Clin Oncol. 2016 Aug;13(8):516-24. doi: 10.1038/nrclinonc.2016.30. Epub 2016 Mar 8.

  PMID: 26951040 RESULT

• Stamell EF, Wolchok JD, Gnjatic S, Lee NY, Brownell I. The abscopal effect associated with a systemic anti-melanoma immune response. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):293-5. doi: 10.1016/j.ijrobp.2012.03.017. Epub 2012 May 5.

  PMID: 22560555 RESULT

• Daly ME, Monjazeb AM, Kelly K. Clinical Trials Integrating Immunotherapy and Radiation for Non-Small-Cell Lung Cancer. J Thorac Oncol. 2015 Dec;10(12):1685-93. doi: 10.1097/JTO.0000000000000686.

  PMID: 26484629 RESULT

• Abuodeh Y, Venkat P, Kim S. Systematic review of case reports on the abscopal effect. Curr Probl Cancer. 2016 Jan-Feb;40(1):25-37. doi: 10.1016/j.currproblcancer.2015.10.001. Epub 2015 Oct 9.

  PMID: 26582738 RESULT

MeSH Terms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Cisplatin

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Radiation Oncology

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2019
• Last Updated: December 1, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)