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pemetrexed plus carboplatin pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) every 4 weeks for up to six cycles, then continued to receive pemetrexed(500 mg/m(2) on day 1) alone every 4 weeks

pemetrexed (500 mg/m(2) on day 1) plus carboplatin (AUC 5 on day 1) combined with gefitinib (250 mg/day on days 5-21) and repeated every 4 weeks for up to six cycles,then continued to receive pemetrexed combined with gefitinib every 4 weeks.

received gefitinib( 250 mg/day)alone. All therapies of 3 groups were continued until progression or unacceptable toxicity or death

pemetrexed plus carboplatin

gefitinib

Baohui Han, Dr

Bo Jin, Dr

Yanjie Niu, Master

Yanwei Zhang, Dr

Tianqing Chu, Dr

Aiqin Gu, Master

Lei Zhu, Master

Jun Pei

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.

Combination of Chemotherapy and Gefitinib as First-line Treatment

Combination of Chemotherapy and Gefitinib as First-line Treatment of Patients With Advanced Lung Adenocarcinoma and Sensitive EGFR Mutations: a Randomised Controlled Trial

Toxicity will be graded according to NCI CTCAE, version 4.0. The analysis of safety/tolerability data will be descriptive; toxicity events will be individually tabulated.

Baohui Han

the chief physician

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 of a 21 days cycle

Pemetrexed 500 mg/m2 i.v. over approximately 10 minutes on day 1 and Carboplatin AUC 5 i.v. over approximately 30 minutes on day 1 (beginning approximately 30 minutes after the end of the pemetrexed infusion) of a 21 days cycle

Pemetrexed plus carboplatin

Luca Boni, MD

Roberto Labianca, MD

Rodolfo Passalacqua, MD

Marco Merlano, MD

Rodolfo Mattioli, MD

Francesco Di Costanzo, MD

Andrea Decensi, MD

Domenico Amoroso, MD

Alfredo Falcone, MD

Dino Amadori, MD

Emilio Baietta, MD

Fausto Barbieri, MD

Paolo Bidoli, MD

Andrea Ardizzoni, MD

Lucio Crinò, MD

Corrado Boni, MD

Filippo De Marinis, MD

Antonio Contu, MD

Libero Ciuffreda, MD

Barni Sandro, MD

Antonio Santo, MD

The aim of this study is to compare time to progression between the combination pemetrexed-carboplatin and pemetrexed alone in previously treated patients with locally advanced or metastatic NSCLC.

In spite of the superiority of single agent over best supportive care in second-line NSCLC, the prognosis of these patients remains poor with a median survival of 6-7 months, justifying the evaluation of new regimens in this setting. An open question in the second-line treatment of NSCLC remains the possible superiority of combination chemotherapy over single agent, as it has been clearly demonstrated in first-line. Particularly, the addition of platinum to either docetaxel or pemetrexed should be further investigated especially in patients with prior response/stable disease to platinum-based first-line chemotherapy. Pemetrexed has shown anti-tumor activity in combination with other chemotherapy agents, including gemcitabine, vinorelbine, taxanes, cisplatin and carboplatin. In this multicenter, open label, randomized phase II trial, pemetrexed 500 mg/m2 and carboplatin AUC 5 will be administered on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses in the experimental arm. The control arm will be pemetrexed as single agent at 500 mg/m2 on day 1 every 3 weeks until progression of disease or for a maximum of 4 courses.

Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC

Randomized Phase II Study of Pemetrexed Versus Pemetrexed and Carboplatin as Second Line Chemotherapy in Advanced Non-small-cell Lung Cancer (NSCLC).

Gruppo Oncologico Italiano di Ricerca Clinica

Dr. Corrado Boni

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination of Chemotherapy and Gefitinib as First-line Treatment	NCT02148380	Non-Small-Cell ...	pemetrexed plus... gefitinib	18 Years - 65 Years	Shanghai Chest Hospital
Combination of Chemotherapy and Gefitinib as First-line Treatment	NCT02148380	Non-Small-Cell ...	pemetrexed plus... gefitinib	18 Years - 65 Years	Shanghai Chest Hospital
Pemetrexed +/- Carboplatin as Second Line Treatment in NSCLC	NCT00786331	Advanced Non-Sm...	Pemetrexed Pemetrexed plus...	18 Years -	Gruppo Oncologico Italiano di Ricerca Clinica

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