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, 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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
CSWOG002
- NCT ID:
NCT03341494
Conditions
- NSCLC Stage IV
- Chemotherapy Effect
Interventions
| Drug | Synonyms | Arms |
|---|
| Thalidomide | | Gefitinib 250mg qd |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Gefitinib 250mg qd thalidomide 200mg qn | Experimental | | |
| Gefitinib 250mg qd | Active Comparator | | |
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
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | PFS |
| Time Frame: | 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 |
| Safety Issue: | |
| Description: | progression-free survival |
Secondary Outcome Measures
| Measure: | ORR |
| Time Frame: | through study completion, and average of 2 years |
| Safety Issue: | |
| Description: | Overall Response Rate |
| Measure: | OS |
| Time Frame: | From date of randomization until the date of death or date of last visit/contact, whichever came first, assessed to at least 36 months |
| Safety Issue: | |
| Description: | Overall Survival |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Fujian Cancer Hospital |
Last Updated
November 14, 2017
