Chemotherapy Plus Gefitinib for Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial
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ClinicalTrials.gov Identifier: NCT02951637 |
Recruitment Status : Unknown
Verified October 2016 by Aiqin Gu, Shanghai Chest Hospital.
Recruitment status was: Not yet recruiting
First Posted : November 1, 2016
Last Update Posted : November 1, 2016
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Condition or disease | Intervention/treatment | Phase |
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Lung Adenocarcinoma | Drug: Pemetrexed plus carboplatin combined with gefitinib Drug: Gefitinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Chemotherapy Plus Gefitinib Versus Gefitinib Alone as First-line Treatment for Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomized Controlled Trial |
Study Start Date : | December 2016 |
Estimated Primary Completion Date : | April 2018 |
Estimated Study Completion Date : | December 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A
Patient will be administrated with Pemetrexed plus carboplatin combined with gefitinib
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Drug: Pemetrexed plus carboplatin combined with gefitinib
Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks.
Other Name: Combination of chemotherapy and EGFR TKI |
Experimental: Group B
Patient will be administrated with gefitinib
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Drug: Gefitinib
Gefitinib (250mg daily)
Other Name: EGFR TKI |
- Progression-free survival (PFS) [ Time Frame: 16 months ]
- overall survival (OS) [ Time Frame: 32 months ]
- Objective response rate (ORR) [ Time Frame: 6 months ]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 6 months ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients had to voluntarily join the study and give written informed consent for the study;
- Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic stage IIIB or IV Non-Small Cell Lung Cancer (NSCLC);
- A cytologic diagnosis is acceptable (FNA or pleural fluid cytology)
- Sensitive EGFR mutations (19del, 21L858R);
- At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumours (RECIST) criteria;
- Patients did not receive systemic anti-cancer therapy previously;
- Able to comply with study and follow-up procedures;
- Age >= 18 years, ECOG PS: 0-1, estimated survival duration more than 3 months;
Exclusion Criteria:
- Small cell lung cancer (including patients with mixed small cell lung cancer and non-small cell lung cancer);
- Evidence of small cell, carcinoid, or mixed small cell/non-small cell histology;
- EGFR wild-type patients, or patients with rare EGFR mutations or complex EGFR mutations;
- Previously (within 5 years) or presently suffering from other malignancies, except for cured cervical carcinoma in situ, non-melanoma skin cancers and superficial bladder cancer [Ta (noninvasive carcinoma), Tis (carcinoma in situ) and T1 (invasion into lamina propria)];
- Symptomatic or untreated brain metastases;
- 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 (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible);
- 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;
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption;
- Pregnancy or lactation.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02951637
Contact: Aiqin Gu, MD | 13916720655 | Guaiqin11@126.com |
Principal Investigator: | Aiqin Gu, MD | Shanghai Chest Hospital |
Responsible Party: | Aiqin Gu, Principal Investigator, Shanghai Chest Hospital |
ClinicalTrials.gov Identifier: | NCT02951637 |
Other Study ID Numbers: |
Chest004 |
First Posted: | November 1, 2016 Key Record Dates |
Last Update Posted: | November 1, 2016 |
Last Verified: | October 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Adenocarcinoma, EGFR, Gefitinib, Pemetrexed, Carboplatin |
Adenocarcinoma Adenocarcinoma of Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Carboplatin Pemetrexed Gefitinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |