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Status unknownNCT02738983Updated Apr 14, 2016

RT Plus EGFR-TKI for Wild-type NSCLC

A Phase 2 interventional study of Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®) and Radiotherapy in Non-small Cell Lung Cancer and Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI), sponsored by Hangzhou Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-04-14.

Sponsored by Hangzhou Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

Concurrent chemoradiotheray is the standard care for patients with locally advanced non-small cell lung cancer (NSCLC), but often accompanying with high toxicity and poor tolerability. Radiosensitization of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKI) has been proved in preclinical studies, and the safety of TKI combined with thoracic radiotherapy has also been evaluated in several phase II trials. The aim of study is to investigate the efficacy and safety of thoracic radiotherapy combined with TKI in wild-type EGFR patients who refused or unsuitable for concurrent chemoradiotherapy.

02

Conditions studied

  • Non-small Cell Lung Cancer
  • Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI)

Keywords

  • Non-small cell lung cancer
  • epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI)
  • Radiotherapy
  • wild type
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's planned enrollment of 22 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Hangzhou Cancer Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. NSCLC confirmed by histopathology or cytology;
  2. Stage IIA - IV NSCLC ,unresectable and could not tolerate chemoradiotherapy;
  3. Has measurable lesion [according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, must have at least one evaluable lesion with the longest dimension >= 10mm; if the evaluable lesion is lymph node, the shortest dimension should be measured and >=15mm];
  4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
  5. Expectancy life >= 3 months;

Exclusion criteria

Exclusion Criteria:

  1. Had systemic anit-NSCLC treatments;
  2. Had be treated by HER-targeting agents;
  3. Had local radiotherapy for NSCLC;
  4. Has upper gastrointestinal physiological disorders, or malabsorption syndrome, or intolerance of oral medication, or active peptic ulcer;
  5. Diagnosed other malignant tumor besides NSCLC within 5 years prior the study treatment (except having simple surgical resection with 5-year disease free survival, cured in situ of cervical carcinoma, cured basal cell carcinoma and bladder epithelial tumor);
  6. Any evidence to indicate moderate or severe chronic obstructive pulmonary disease (COPD);
  7. Known hypersensitivity to EGFR-TKI agents or relevant components in the formulation;
  8. Uncontrolled eye inflammation or infection, or any potential circumstances lead to eye inflammation or infection;
  9. Pregnancy or breast-feeding women;
  10. Ingredients mixed with small cell lung cancer patients;
  11. Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or puts the subject at high risk for treatment-related complications.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Bioradiotherapy

    Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day) with concurrent radiotherapy to a total radiation dose of 60-66 Gray (Gy).

    Drug: Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®) · Radiation: Radiotherapy

Interventions

  • DrugErlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®)

    Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).

  • RadiationRadiotherapy

    Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.

06

What researchers measure

Primary outcomes

  1. Response rate

    Time frame: week 3-4

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v3.0.

    Toxicity of the treatment will be evaluated according to the common toxicity criteria for adverse events version 3.0 (CTCAE v3.0).

    Time frame: year 0- year 2

  2. Progression-free survival

    Progression-free survival (PFS) will be calculated from the date of treatment initiation to the date of documented failure (local recurrence or metastasis occurrence) or the date of the last follow-up for those remaining.

    Time frame: year 0- year 2

  3. Overall survival

    Overall survival (OS) wiil be determined as the time (in months) between the first day of therapy and the last follow-up or the date of death.

    Time frame: year 0- year 2

07

Study locations

1 of 1 sites recruiting
  • Hangzhou Cancer Hospital
    Hangzhou, Zhejiang 310000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02738983
Lead sponsor
Hangzhou Cancer Hospital
Responsible party
Zhishuang Zhen (MD, Hangzhou Cancer Hospital) — Principal investigator
First posted
Apr 14, 2016
Start date
Jan 2012
Primary completion
Dec 2016 (estimated)
Completion
Dec 2017 (estimated)
Last update
Apr 14, 2016

Study contacts

Zhishuang Zheng, Dr
Contact
zhengzs19841130@163.com
+8657186826086
Shixiu Wu, MD
study chair · Hangzhou Cancer Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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