A Study of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy

NCT02788058 | Unknown Phase 2 DMC

• 1 other identifier: HZCH-2016-08
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy for limited metastatic NSCLC harboring sensitizing EGFR mutations after first line TKI therapy. An exploratory biomarker analysis in blood and tumor samples is also planned.

Conditions

Lung Adenocarcinoma; EGFR Positive Non-small Cell Lung Cancer

Keywords

Hypofractionated Radiotherapy; EGFR Positive; Lung Adenocarcinoma; Limited Metastases

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  3 years

Secondary Outcomes (8)

• Frequency of T790M mutation before treatment detected by ctDNA

  1 months

• Abundance of T790M mutation before treatment detected by ctDNA

  1 months

• Frequency of T790M mutation after radiotherapy detected by ctDNA

  3 months

• Abundance of T790M mutation after radiotherapy detected by ctDNA

  3 months

• Frequency of T790M mutation after 1 year detected by ctDNA

  1 year

Study Arms (2)

EGFR-TKI

EXPERIMENTAL

Patients take EGFR-TKI alone till tumor progression

Drug: EGFR-TKI

EGFR-TKI+hypofractionated radiotherapy

ACTIVE COMPARATOR

After 3 mos TKI, patients with limited metastatic take EGFR-TKI concurrent with hypofractionated radiotherapy till tumor progression.

Drug: EGFR-TKI; Radiation: Thoracic Hypofractionated Radiotherapy

Interventions

EGFR-TKI DRUG

Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid

Also known as: Gefitinib/Erlotinib/Icotinib

EGFR-TKI; EGFR-TKI+hypofractionated radiotherapy

Thoracic Hypofractionated Radiotherapy RADIATION

40-45 Gy/5-15f

EGFR-TKI+hypofractionated radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and became oligometastatic disease after 3 months TKI, evaluated by PET/CT scan, brain MRI, and abdomen ultrasound (≤6 discrete lesions of disease, exclusive of the brain metastases, ≤3 lesions in the liver, ≤3 lesions in the lung);
• All sites of disease must be amenable to definitive RT;
• An intrathoracic lymph nodal station is considered 1 discrete lesion, according to IASLC lymph nodal station map;
• Age 18 years or older;
• ECOG Performance Status 0-2;
• Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal;
• For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment;
• Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter;
• Patients and their family signed the informed consents;

You may not qualify if:

• Received chemotherapy before TKI therapy;
• Brain parenchyma or leptomeningeal disease;
• Any site of disease that is not amenable to definitive RT;
• Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment;
• Any medical co-morbidities that would preclude radiation therapy.

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

MeSH Terms

Conditions

Adenocarcinoma of Lung

Interventions

Gefitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Shenglin Ma, MD

CONTACT

0571-56007908; mashenglin@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2016
• First Posted: June 2, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: June 2, 2016

Record last verified: 2016-05