Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer

NCT03113851 | Completed Phase 2

• 1 other identifier: 2016YJZ23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether radiation combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe and effective for patients with metastatic non-small cell lung cancer.

Conditions

Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• The abscopal effect rate

  The proportion of patients with an abscopal response assessed after the initiation of treatment

  up to 50 months

Secondary Outcomes (2)

• Progression free survival

  up to 84 months

• Overall survival

  up to 84 months

Study Arms (1)

Radiotherapy and rhGM-CSF

EXPERIMENTAL

Patients with metastatic non-small cell lung cancer received 3.5 Gy per fraction to a total dose of 35 Gy/ 10 fractions over 2 weeks, combined with rhGM-CSF (125 μg/m2).

Radiation: Radiotherapy; Drug: rhGM-CSF

Interventions

Radiotherapy RADIATION

One lesion received radiotherapy for 35 Gy in 10 fractions and rested for one week; then another metastatic lesion were treated with radiotherapy for 35 Gy in 10 fractions.

Also known as: radiation

Radiotherapy and rhGM-CSF

rhGM-CSF DRUG

Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy

Also known as: recombinant human GM-CSF

Radiotherapy and rhGM-CSF

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years;
• Histologically proven non-small-cell lung cancer；
• Stage IV according to UICC stage system(version 7,2009), at least with three evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;
• Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);
• ECOG performance status: 0-1;
• Life expectancy ≥ 3 months.
• Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;
• Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;
• Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;
• Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

You may not qualify if:

• Allergic to GM-CSF, or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;
• receiving treatment of other trials;
• Any unstable systemic disease, including active infection, symptomatic congestive heart failure, myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;
• unwilling to sign consent;
• Women in pregnancy or lactation;
• Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Radiotherapy; Radiation; regramostim; Granulocyte-Macrophage Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Phenomena; 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

Study Officials

• Anhui Shi, MD.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 14, 2017
• Study Start: August 14, 2017
• Primary Completion: August 14, 2018
• Study Completion: October 14, 2018
• Last Updated: June 13, 2023

Record last verified: 2023-06

Locations

CN (1)