Combination of Chemotherapy and Gefitinib as First-line Treatment
NCT02148380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121
Last updated 2016-04-20
Summary
The results of fastact2 show that chemotherapy plus erlotinib significantly prolonged PFS and OS of patients with NSCLC. However, outcome of the combination therapy are similar to those reported in several trials of single-agent EGFR TKIs. So which is the optimal first-line treatment for patients who harbored a sensitive EGFR mutation? The investigators need a head-to-head study to reply.
Conditions
- Non-Small-Cell Lung Cancer
Interventions
- DRUG
-
pemetrexed plus carboplatin
- DRUG
-
gefitinib
Sponsors & Collaborators
-
Baohui Han
lead OTHER
Principal Investigators
-
Baohui Han, Dr · Vice President of Shanghai Chest Hospital,Sponsor of study
-
Bo Jin, Dr · Study Leader,Doctor of Shanghai Chest Hospital
-
Yanjie Niu, Master · Doctor of Shanghai Chest Hospital
-
Yanwei Zhang, Dr · Doctor of Shanghai Chest Hospital
-
Tianqing Chu, Dr · Doctor of Shanghai Chest Hospital
-
Aiqin Gu, Master · Doctor of Shanghai Chest Hospital
-
Lei Zhu, Master · Doctor of Shanghai Chest Hospital
-
Jun Pei · Doctor of Shanghai Chest Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-05-31
- Primary Completion
- 2014-12-31
- Completion
- 2015-12-31
Countries
- China
Study Locations
More Related Trials
-
Safety and Effectiveness Study of Chemotherapy in Combination With Erlotinib,or Sequential Erlotinib for Treatment in Patients With NSCLC
NCT02037997 ·Status: UNKNOWN ·Phase: PHASE2
-
A Multicenter Randomized Phase III Study Comparing Second-line Treatment With Chemotherapy Associated or Not to Erlotinib in NSCLC Patients With Secondary Resistance to TKI-EGFR
NCT02178397 ·Status: TERMINATED ·Phase: PHASE3
-
Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation
NCT02095782 ·Status: TERMINATED ·Phase: PHASE2
-
A Study to Evaluate Safety and Efficacy of HS-10296 as First-Line Treatment in Patients
NCT03849768 ·Status: UNKNOWN ·Phase: PHASE3
-
Gefitinib Combine Radiotherapy as Therapy for Patients With NSCLC Harbouring Sensitive Mutations of EGFR
NCT03381430 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
A Phase II Study of Fruquintinib in Combination With Gefitinib in Patients With Advanced Non-small Cell Lung Cancer
NCT02976116 ·Status: COMPLETED ·Phase: PHASE2
-
Intercalating and Maintenance Gefitinib in Combination With Chemotherapy for Advanced EGFR-mutant NSCLC
NCT02299765 ·Status: TERMINATED ·Phase: PHASE4
-
Abivertinib Maleate Versus Geifitinib in Patients With Advanced Non-small Cell Lung Cancer With Sensitive EGFR Mutation
NCT03856697 ·Status: UNKNOWN ·Phase: PHASE3
-
Study of Chemotherapy Sequenced by or Combined With EGFR-TKIs for NSCLC Patients Failed to EGFR-TKIs Therapy
NCT01746277 ·Status: UNKNOWN ·Phase: PHASE2
-
Pemetrexed Combined With Synchronous Gefitinib as Adjuvent Therapy in Patient With EGFR Mutant Lung Adenocarcinoma
NCT02518802 ·Status: UNKNOWN ·Phase: PHASE3
-
Intercalated Combination of Chemotherapy and Tyrosine Kinase Inhibitors as First-line Treatment for Patients With Non-Small-Cell Lung Cancer
NCT02031601 ·Status: UNKNOWN ·Phase: PHASE4
-
Apatinib Combine With Platinum-Based Doublet Chemotherapy for First-line Treatment of Advanced NSCLC
NCT03201146 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Gefitinib With Anlotinib in Advanced Non-squamous NSCLC Patients With Uncleared Plasma ctDNA EGFRm After First-line Treatment With Gefitinib
NCT04358562 ·Status: UNKNOWN ·Phase: PHASE2
-
Erlotinib Versus Gemcitabine/Cisplatin as (Neo)Adjuvant Treatment in Non-small Cell Lung Cancer
NCT01407822 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Evaluating Efficacy and Safety of Erlotinib Versus Gemcitabine Plus Cisplatin as Neoadjuvant Chemotherapy
NCT01297101 ·Status: TEMPORARILY_NOT_AVAILABLE
-
Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer
NCT06755684 ·Status: RECRUITING ·Phase: PHASE2
-
A Study of Erlotinib (Tarceva) Versus Gemcitabine/Cisplatin as First-line Treatment in Patients With Non-small Cell Lung Cancer With EGFR Mutations
NCT01342965 ·Status: COMPLETED ·Phase: PHASE3
-
Real-world Experience With Combination Chemotherapy and Osimertinib in Poor Prognostic Group of Metastatic EGFR-mutated Lung Adenocarcinoma
NCT06918782 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Gefitinib Combined With Chemotherapy or Antiangiogensis in Patients With Bim Deletion or Low EGFR Mutation Abundance
NCT02930954 ·Status: UNKNOWN ·Phase: PHASE2
-
Erlotinib Versus Pemetrexed as Second-Line Therapy in Treating Patients With Advanced Lung Adenocarcinoma
NCT01565538 ·Status: COMPLETED ·Phase: PHASE2
-
Gefitinib in Combination With Anlotinib or Placebo in Previously Untreated EGFR-mutant NSCLC
NCT04028778 ·Status: UNKNOWN ·Phase: PHASE3
-
Erlotinib Intercalated With Chemotherapy Versus Erlotinib as First Line Treatment in Stage IIIB/IV NSCLC Patients With EGFR Mutation
NCT02001896 ·Status: UNKNOWN ·Phase: PHASE3
-
Third-generation EGFR-TKI Plus Anlotinib as Maintenance for NSCLC With Small Cell Transformation After EGFR-TKI Resistance
NCT06634667 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Phase III Trial to Evaluate the Elortinib vs Gefitinib in Advanced NSCLC With EGFR Exon 19 or 21 Mutations
NCT01024413 ·Status: COMPLETED ·Phase: PHASE3
-
Phase I Study of the Combination of Anlotinib With Gefitinib
NCT03602027 ·Status: UNKNOWN ·Phase: NA