Clinical trial NCT03341494: EGFR Mutation Positive NSCLC Patients With Gefitinib and Thalidomide
Official title: A Randomized Phase II Study of Gefitinib Alone Versus Gefitinib Plus Thalidomide for Advanced Non-small Cell Lung Cancer With Epidermal Growth Factor Receptor Activating Mutations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: NSCLC Stage IV
Chemotherapy Effect
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2017-11-14
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Gefitinib is combined with Antiangiogenesis agent thalidomide, Therefore Chinese data of treating EGFR mutation positive NSCLC patients with Gefitinib and thalidomide is significantly necessary for developing new standard treatment in first-line therapy in Chinese EGFR mutant NSCLC patients.

In this study, The investigators will investigate the efficacy and safety of Gefitinib and thalidomide combination compare to Gefitinib alone in Chinese EGFR-mutant NSCLC patients.

Detailed description: EGFR-TKIs are the standard first-line treatment option for EGFR-mutant NSCLC. After a randomized phase II trial, JO25567 was presented at 2014 ASCO, the synergistic effect of progression-free survival(PFS) could be expected when EGFR TKI, Gefitinib is combined with Antiangiogenesis agent thalidomide, . Even Chinese and Japanese are classified as Asian based on location, the figure of Chinese is more tended to Western people due to the dietary life in recent years. However the incidence rate of EGFR mutation positive patients in Chinese is much higher than Western countries.

Therefore Chinese data of treating EGFR mutation positive NSCLC patients with Gefitinib and thalidomide is significantly necessary for developing new standard treatment in first-line therapy in Chinese EGFR mutant NSCLC patients.

In this study, The investigators will investigate the efficacy and safety of Gefitinib and thalidomide combination compare to Gefitinib alone in Chinese EGFR-mutant NSCLC patients.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed stage IIIB \& IV non-small cell lung cancer other than squamous cell carcinoma

  * Patients with one or more measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
  * Locally diagnosed sensitive EGFR mutation positive (Exon 19 deletion or L858R)
  * ECOG performance 0\~1
  * Age ≥ 19 years and - No previous treatment

Adequate organ function by following:

* ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL
* Serum bilirubin \< 1 x UNL, AST (SGOT) and ALT (SGPT) \< 2.5 x UNL, If Liver metastasis, Serum bilirubin \< 3 x UNL, AST (SGOT) and ALT (SGPT) \< 5 x UNL
* Serum Cr ≤ 1 x UNL
* Patients who have had undergone radiotherapy are acceptable if patients meet all of the following criteria:

  * No history of irradiation to pulmonary tumor lesions.
  * In case of palliative irradiation to bone lesions in lung: at least 12 weeks must have passed at the date of registration since the last irradiation of the sites.
  * In case of irradiation to non-pulmonary sites: at least two weeks must have passed at the date of inclusion since the last irradiation of the sites
* At the time of registration, at least the following period has passed since last date of the prior therapy or procedure:

  * Surgery(including exploratory/ examination thoracotomy): 4 weeks
  * Pleural cavity drainage: 1 weeks
  * Pleurodesis without anti-neoplastic agents (inclusive of BRM such as Picibanil): 2 week
  * Biopsy accompanied by incision (including thoracoscopic biopsy): 2 week
  * Procedure for trauma (exclusive of patients with unhealed wound): 2 weeks
  * Transfusion of blood, preparation of hematopoietic factor: 2 week
  * Puncture and aspiration cytology: 1 week
  * Other investigational product: 4 weeks
* Written informed consent form

Exclusion Criteria:

* • Previous history of malignancy within 3 years from study entry except treated non-melanomatous skin cancer, uterine cervical cancer in situ, or thyroid cancer

  * Prior chemotherapy or systemic anti-cancer therapy for metastatic disease but postoperative adjuvant or neoadjuvant therapy of 6 months or more previously is allowed
  * Patients who received previous treatment for lung cancer with drugs
  * Symptomatic or uncontrolled central nervous system (CNS) metastases
  * Patients with increased risk of bleeding, clinically significant cardiovascular diseases, a history of thrombosis or thromboembolism in the 6 months prior to treatment, gastrointestinal problems, and neurologic problems
  * Any significant ophthalmologic abnormality
  * Pre-existing parenchymal lung disease such as pulmonary fibrosis
  * Known allergic history of Erlotinib or Bevacizumab
  * Interstitial lung disease or fibrosis on chest radiogram
  * Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
  * Pregnant or nursing women

Primary outcomes:
measure: PFS
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to at least 36 months
Secondary outcomes:
measure: ORR
timeFrame: through study completion, and average of 2 years
measure: OS
timeFrame: From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Cancer Hospital Radiation Oncology Department
state: Fujian
city: Fuzhou
country: China
facility: Fujian cancer hospital
state: Fujian
Study officials:
affiliation: Fujian Cancer Hospital
name: Gen lin
role: PRINCIPAL_INVESTIGATOR
References: