Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC
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ClinicalTrials.gov Identifier: NCT03374280 |
Recruitment Status : Unknown
Verified March 2019 by Haihong Yang, MD, Pricipal investigator, Guangzhou Medical University.
Recruitment status was: Recruiting
First Posted : December 15, 2017
Last Update Posted : March 28, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: pemetrexed/cisplatin intercalating gefitinib Drug: pemetrexed/cisplatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 178 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma) |
Actual Study Start Date : | December 1, 2016 |
Estimated Primary Completion Date : | December 30, 2019 |
Estimated Study Completion Date : | December 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: pemetrexed/cisplatin intercalating gefitinib
pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 ;gefitinib 250mg d3-20d, to 4 cycles. pemetrexed 500mg/m2 d1; gefitinib 250mg d2-20d to disease progression or untolerable |
Drug: pemetrexed/cisplatin intercalating gefitinib |
Active Comparator: pemetrexed/cisplatin
pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable
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Drug: pemetrexed/cisplatin |
- disease progression-free survival [ Time Frame: 3 years ]the last patient into group for three years or dead
- overall survival [ Time Frame: 5 years ]the last patients into group for 5 years or dead
- side-effects [ Time Frame: 3 years ]the last patient into group for 3 years or dead
- overall response rate [ Time Frame: 3 years ]the last patient into group for 3 years or dead

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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:
1.Histological or cytological diagnosis of small-cll lung cancer histology
2.18 years or older
3.Eastern Cooperative Oncology Group (ECOG) Performance Status no more than 2
4.Local stage SCLC without distant metastases
5.After 1st-line chemotherapy (EP or IP) at least 4 cycles
6.After radical radiotherapy for primary tumor and lymph node drainage area:including concurrent or sequence chemoradiotherapy
7.CR or PR assessment by RECIST(1.0) before randomized
8.Haemoglobin 10.0 g/dl, Absolute neutrophil count (ANC) 1.5^9/L, platelets 100 x 10^9/L
9.Total bilirubin 1.5 x upper limit of normal (ULN) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN in the absence of liver metastases, or < 5 x ULN in case of liver metastases
10.Creatinine clearance 60ml/min (calculated according to Cockcroft-gault formula)
Exclusion Criteria:
- Mixed non-small cell lung cancer histology
- Neck and supraclavicular lymph node metastasis
- Be allergic to temozolomide or intolerable to radiotherapy
- Any unstable systemic disease
- Pregnant or lactating women

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): NCT03374280
Contact: Hailing Yang, MD | 00862083062825 | bjrf2009@yahoo.com | |
Contact: Fengnan Wang, MD | 00862083062825 | wangfengnan@hotmail.com |
China, Guangdong | |
The first affiliated hospital of Guangzhou MC | Recruiting |
Guangzhou, Guangdong, China, 510120 | |
Contact: Haihong Yang, MD 0862083062825 bjrf2009@yahoo.com | |
Principal Investigator: Haihong Yang, Dr. |
Study Director: | Jiajia Yu, MD | the ethics committee of the first affiliated hospital of Guangzhou MC |
Responsible Party: | Haihong Yang, MD, Pricipal investigator, Chief Physician, Guangzhou Medical University |
ClinicalTrials.gov Identifier: | NCT03374280 |
Other Study ID Numbers: |
GuangzhouMC |
First Posted: | December 15, 2017 Key Record Dates |
Last Update Posted: | March 28, 2019 |
Last Verified: | March 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
non small cell lung cancer Gefitinib EGFR negative Pemetrexed |
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |
Cisplatin Pemetrexed Gefitinib Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Protein Kinase Inhibitors |