Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02282267
Other study ID # BJCHDTC002
Secondary ID
Status Active, not recruiting
Phase N/A
First received October 31, 2014
Last updated February 22, 2017
Start date October 2014
Est. completion date February 2018

Study information

Verified date February 2017
Source Beijing Cancer Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study was proposed to validate the efficacy of gefitinib as first-line therapy in advanced lung adenocarcinoma with EGFR mutation determined by plasma cf-DNA.


Description:

Patients without enough tissue for EGFR mutation detection can also have opportunity to use EGFR-TKI as first line therapy. Meanwhile, this study was also proposed to explore the best intervention time of anti-resistant drugs (such as AZD 9291, a T790M inhibitor) through the quantitative and dynamic analysis of EGFR sensitive and resistant mutation in plasma cf-DNA during EGFR-TKI treatment process.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 188
Est. completion date February 2018
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Provision of informed consent prior to any study specific procedures.

- Male or female patients aged ranging from 18 to 75 years old.

- Histological confirmation of lung adenocarcinoma. Attention: the paraffin embedded cytological samples extracted from pleural effusion are acceptable. Adeno-squamous carcinoma is not allowed to enroll. Sputum cytology alone cannot be acceptable. Bronchoalveolar lavage and fine needle aspiration cytology specimens for lesions also cannot acceptable.

- Metastatic lung adenocarcinoma (stage ?, IASLC, 2009).

- EGFR sensitive mutation (including exon 19 del and/or exon 21 L858R) in plasma cf-DNA by ddPCR.

- Chemotherapy, immunotherapy and other systemic anti-cancer treatment (such as EGFR inhibitor including other EGFR tyrosine kinase inhibitor and EGFR antibody, and anti-vascular therapy including vascular epithelial growth factor receptor inhibitor and Endostar) naïve. Radical surgery and radiotherapy must be completed at least 6 months before start of study treatment. Adjuvant chemotherapy is allowed and must be finished at least 6months before start of study drug. Palliative radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity.

- At least one lesion, not previously irradiated, that can be accurately measured at baseline as 10mm in the longest diameter (lymph nodes must have short axis more than 15mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.

- WHO Performance Status 0, 1 or 2.

- Criteria for laboratory examinations:

Blood white cell count=3.0*109/L, Neutrophile cell count =1.5*109/L Platelet count =100*109/L Total bilirubin (TB) = 1.5 times upper limit of normal Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =2 times upper limit of normal; for subjects with hepatic metastasis, AST, ALT= 5 times upper limit of normal Creatinine clearance=50ml/min

Exclusion Criteria:

- Known severe allergic to gefitinib or any excipient of the product.

- Considered to require radiotherapy to the lung at the time of study entry or in the near future.

- Newly diagnosed symptomatic central nervous system (CNS) metastasis or spinal cord compression unless treated with surgery and/or radiation and stable without steroid for at least 2 weeks.

- Uncontrolled massive pleural or pericardial effusion.

- Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease.

- The presence of idiopathic pulmonary fibrosis in baseline CT scans.

- Combined use of phenytoin, rifampin, carbamazepine, pentobarbital or St. John's wort.

- Any obvious ocular anomalies, especially severe dry eye syndrome, keratoconjunctivitis sicca, serious exposure keratitis or other potentially increased epithelial lesions.

- As judged by the investigator, any evidence of severe of uncontrolled systemic disease (e.g. active infection, uncontrolled hypertension unstable angina, congestive hear failure, liver, kidney or metabolic diseases).

- Could not accept oral administration, need intravenous nutrition, previous operation that affect absorption or active peptic ulcer.

- Pregnant or lactating women.

- Prior administration of other study drug or drug without approval within 30 days before the first day of study drug administration.

- Other co-existing malignancies on malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intra-mucosal gastric cancer.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Gefitinib
Iressa 250mg oral daily

Locations

Country Name City State
China beijing Cancer Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary objective response rate of gefitinib up to 6 months
See also
  Status Clinical Trial Phase
Recruiting NCT02898857 - Chemoresistance and Involvement of the NOTCH Pathway in Patients With Lung Adenocarcinoma N/A
Completed NCT02127359 - Whole-Exome Sequencing (WES) of Cancer Patients
Recruiting NCT01249066 - Expression of AMP-activated Protein Kinase (AMPK) Protein in Lung Adenocarcinoma N/A
Not yet recruiting NCT04482829 - TCM in the Treatment of Lung Adenocarcinoma N/A
Recruiting NCT04929041 - Testing the Addition of Radiation Therapy to Immunotherapy for Stage IV Non-Small Cell Lung Cancer Patients Who Are PD-L1 Negative Phase 2/Phase 3
Terminated NCT04691375 - A Study of PY314 in Subjects With Advanced Solid Tumors Phase 1
Terminated NCT02621333 - Chemotherapy Combined Autologous Cytokine-induced Killer Cells in Naive Stage IV EGFR-wild Type Lung Adenocarcinoma Phase 2
Not yet recruiting NCT01942629 - Prognostic Value of the Marker P63 in Adenocarcinoma of Lung, Breast, and Pancreas N/A
Recruiting NCT01482585 - Study of Early-stage Lung Adenocarcinoma for Early Detection and Effective Treatment Strategy N/A
Recruiting NCT03376737 - Study of Apatinib as the Maintenance Therapy in Advanced Lung Adenocarcinoma Phase 2
Recruiting NCT05537922 - I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy
Recruiting NCT04937283 - Segmentectomy Versus Lobectomy for Lung Adenocarcinoma ≤ 2cm N/A
Recruiting NCT06255197 - Characteristics, Treatment Patterns and Outcomes for Patients With Surgically Resected Lung Cancers
Completed NCT02093000 - A Study Examining Maintenance Bevacizumab (Avastin®) Monotherapy in Participants With Advanced Lung Adenocarcinoma N/A
Recruiting NCT04119024 - Gene Modified Immune Cells (IL13Ralpha2 CAR T Cells) After Conditioning Regimen for the Treatment of Stage IIIC or IV Melanoma or Metastatic Solid Tumors Phase 1
Terminated NCT04682431 - A Phase 1a/1b FIH Study of PY159 and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors Phase 1
Recruiting NCT05736991 - Deep Learning Signature for Predicting the Novel Grading System of Clinical Stage I Lung Adenocarcinoma
Enrolling by invitation NCT05136014 - Evaluation of the Response to Tyrosine Kinase Inhibitors in Localized Non-small Cell Lung Cancer (NSCLC) Patients With EGFR Mutation in a Patient-derived Organoid Model
Terminated NCT05012397 - Milademetan in Advanced/Metastatic Solid Tumors Phase 2
Recruiting NCT05266846 - Pembrolizumab Plus Bevacizumab and Chemotherapy for ALK-rearranged NSCLC With Persistent 5'ALK Phase 2