TrialReader

EGFR-TKI With/Without Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

NCT03002844 — Phase 2, Unknown, 50 participants, Shanghai Pulmonary Hospital, Shanghai, China
ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03002844
StatusUnknown
PhasePhase 2
Study typeInterventional; non randomized, parallel, masking: none, treatment
Enrollment50 (Estimated)
SponsorShanghai Pulmonary Hospital, Shanghai, China (Other)
ConditionsNonsmall Cell Lung Cancer, EGFR Gene Mutation
InterventionsEGFR-TK Inhibitor, EGFR-TKI, EGFR-TKI and Chemotherapy (Drug)
Datesstart 2016-12-01, primary completion 2017-08-01 (estimated), completion 2018-12-01 (estimated), first posted 2016-12-26, last updated 2016-12-28

Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Nonsmall Cell Lung Cancer All trials for EGFR Gene Mutation All trials of EGFR-TK Inhibitor All trials of EGFR-TKI

-Summary

BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with/without chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

Expand all sections  ·  Collapse all

+Detailed description

BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

+Arms and interventions

ArmTypeInterventionsDescription
EGFR-TKI and ChemotherapyExperimentalDrug: EGFR-TKI; Drug: EGFR-TKI and Chemotherapygefitinib with pemetrexed/gemcitabine and carboplatin
EGFR-TK InhibitorExperimentalDrug: EGFR-TK InhibitorGefitinib
  • EGFR-TK Inhibitor (Drug), also known as gefitinib: EGFR-TKI (gefitinib 250mg per day)
  • EGFR-TKI (Drug), also known as gefitinib: EGFR-TKI (gefitinib 250mg per day)
  • EGFR-TKI and Chemotherapy (Drug), also known as EGFR-TKI and pemetrexed/gemcitabine and carboplatin: pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w

+Outcome measures

Primary outcomes

  • Progress Free Survival [up to 12 months]

Secondary outcomes

  • Overall Survival [up to 24 months]
  • Overall Response Rate [up to 12 months]
  • Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [up to 12 months]: Safety

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

1. Signed informed consent
2. Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC)
3. Must have measurable or non-measurable disease
4. Must be able to comply with study and follow-up procedures

Exclusion Criteria:

1. Small cell, carcinoid, or mixed small cell lung cancer
2. Malignancies within 3 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
3. Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC
4. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication
5. History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
6. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption
7. Pregnancy or lactation

+Investigators

My Notes