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

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ClinicalTrials.gov Identifier: NCT02788058
Recruitment Status : Not yet recruiting
First Posted : June 2, 2016
Last Update Posted : June 2, 2016
Sponsor:
Information provided by (Responsible Party):
First People's Hospital of Hangzhou

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.

Condition or disease Intervention/treatment Phase
Lung Adenocarcinoma EGFR Positive Non-small Cell Lung Cancer Drug: EGFR-TKI Radiation: Thoracic Hypofractionated Radiotherapy Phase 2

Detailed Description:

Rational:

After inductive TKI therapy in NSCLC with sensitizing EGFR mutations, the residual lesion might be the source of subsequent disease progression, defined as acquired resistance to TKI. Two reasons can be used to explain the formation of the residual lesion:1)there is a subgroup of cancer cells that are not sensitive to TKI therapy because of tumor heterogeneity, like de novo T790M mutation; 2)some cancer cells can keep static state during the beginning treatment, and then develops acquired resistance to TKI therapy under the long-term drug pressure and continue to re-proliferation. From this point of view, elimination of residual lesion provides the chance to reduce or slow the possibility of developing resistance to TKI.

Objective:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Hypofractionated Radiotherapy for Limited Metastatic NSCLC Harboring Sensitizing EGFR Mutations After First Line TKI Therapy
Study Start Date : May 2016
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: EGFR-TKI
Patients take EGFR-TKI alone till tumor progression
Drug: EGFR-TKI
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Erlotinib/Icotinib

Active Comparator: EGFR-TKI+hypofractionated radiotherapy
After 3 mos TKI, patients with limited metastatic take EGFR-TKI concurrent with hypofractionated radiotherapy till tumor progression.
Drug: EGFR-TKI
Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
Other Name: Gefitinib/Erlotinib/Icotinib

Radiation: Thoracic Hypofractionated Radiotherapy
40-45 Gy/5-15f




Primary Outcome Measures :
  1. Progression free survival [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Frequency of T790M mutation before treatment detected by ctDNA [ Time Frame: 1 months ]
  2. Abundance of T790M mutation before treatment detected by ctDNA [ Time Frame: 1 months ]
  3. Frequency of T790M mutation after radiotherapy detected by ctDNA [ Time Frame: 3 months ]
  4. Abundance of T790M mutation after radiotherapy detected by ctDNA [ Time Frame: 3 months ]
  5. Frequency of T790M mutation after 1 year detected by ctDNA [ Time Frame: 1 year ]
  6. Abundance of T790M mutation after 1 year detected by ctDNA [ Time Frame: 1 year ]
  7. Rate of CTCAE grade 2 or higher radiation pneumonitis [ Time Frame: 1 years ]
    We will assess the rate of symptomatic radiation pneumonitis in patients who received the radiation therapy.

  8. To assess the short-term quality of life (QOL) [ Time Frame: 4 months ]
    FACT-E score at the 4 months after docetaxel consolidation therapy



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02788058


Contacts
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Contact: Shenglin Ma, MD 0571-56007908 ext 086 mashenglin@medmail.com.cn

Sponsors and Collaborators
First People's Hospital of Hangzhou
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Responsible Party: First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT02788058    
Other Study ID Numbers: HZCH-2016-08
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: May 2016
Keywords provided by First People's Hospital of Hangzhou:
Hypofractionated Radiotherapy
EGFR Positive
Lung Adenocarcinoma
Limited Metastases
Additional relevant MeSH terms:
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Adenocarcinoma
Adenocarcinoma of Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action