EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC (effect)
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ClinicalTrials.gov Identifier: NCT02886195 |
Recruitment Status : Unknown
Verified July 2016 by Fujian Cancer Hospital.
Recruitment status was: Enrolling by invitation
First Posted : September 1, 2016
Last Update Posted : September 1, 2016
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Condition or disease | Intervention/treatment | Phase |
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EGFR Gene Mutation | Drug: pemetrexed Drug: cisplatin Drug: Erlotinib | Phase 3 |
This is an open-label, randomized, parallel-group controlled clinical trial, and the study subjects recruited in this study are NSCLC patients mutant for EGFR gene (19del or L858R).
Subjects in the concurrent therapy group were given EGFR-TKIs treatment plus concurrent chemotherapy. Patients in the sequential treatment group were assigned to sequential EGFR-TKIs followed by chemotherapy group, which received TKIs monotherapy and then chemotherapy alone after disease progression; and sequential chemotherapy followed by EGFR-TKIs treatment, which was given first-line chemotherapy for 4 to 6 cycles, followed by maintenance therapy with EGFR-TKIs.
The endpoint of this study included clinical efficacy and safety.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | EGFR-TKIs Combine Chemotherapy as First-line Therapy for Patients With Advanced EGFR Mutation-positive NSCLC |
Study Start Date : | July 2016 |
Estimated Primary Completion Date : | July 2019 |
Estimated Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: PC plus erlotinib
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1; concurrent erlotinib 150mg/d d1-21, per 3 week, for 4-6cycles, then erlotinib 150mg/d maintain therapy
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Drug: pemetrexed
500mg/m2 ivgtt d1, per three weeks Drug: cisplatin 80mg/m2 ivgtt d1, per three weeks Drug: Erlotinib 150mg po. every day |
Active Comparator: erlotinib
erlotinib 150mg/d until "progress disease"
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Drug: Erlotinib
150mg po. every day |
Active Comparator: PC
pemetrexed 500mg/m2 d1 plus cisplatin 80mg/m2 d1 for 4-6 cycles
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Drug: pemetrexed
500mg/m2 ivgtt d1, per three weeks Drug: cisplatin 80mg/m2 ivgtt d1, per three weeks |
- Progression-Free Survival (PFS) [ Time Frame: 6 months ]
- Response Rate (RR) [ Time Frame: 2 months ]
- Overall Survival (OS) [ Time Frame: 6 months ]
- Adverse Event (AE) [ Time Frame: 2 months ]NCI CTC 4.03

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Stage Ⅳ EGFR mutation-positive NSCLC
- Initial therapy
- ECOG performance status 0-1
Exclusion Criteria:
- EGFR mutation-negative
- Previous systemic antitumour treatment

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): NCT02886195
Study Chair: | zhiyong he he, master | Fujian province cancer hospital |
Responsible Party: | Fujian Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT02886195 |
Other Study ID Numbers: |
secgolc001 |
First Posted: | September 1, 2016 Key Record Dates |
Last Update Posted: | September 1, 2016 |
Last Verified: | July 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Depending on the process of the study |
Pemetrexed Erlotinib Hydrochloride Antineoplastic Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |