Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

The Phase Three Trials of Pemetrexed/Cisplatin Intercalating Gefitinib vs Pemetrexed/Cisplatin Treating EGFR Wild NSCLC(Non Squamous Cell Carcinoma)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03374280
• Other study ID #: GuangzhouMC
• Status: Recruiting
• Phase: Phase 2
• Start date: December 1, 2016
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2019
• Source: Guangzhou Medical University
• Contact: Hailing Yang, MD
• Phone: 00862083062825
• Email: bjrf2009[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To investigate the curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC

Description:

In preclinical data, it is identified that pemetrexed combined with erlotinib could achieve good response than pemetrexed because EGFR-TKI (erlotinib) could enhance the sensitivity of pemetrexed. So we design the trial to investigate curative effect between Pemetrexed/Cisplatin and Pemetrexed/Cisplatin intercalating Gefitinib Treating EGFR Wild NSCLC.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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:

1. Mixed non-small cell lung cancer histology

2. Neck and supraclavicular lymph node metastasis

3. Be allergic to temozolomide or intolerable to radiotherapy

4. Any unstable systemic disease

5. Pregnant or lactating women

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Drug:
• pemetrexed/cisplatin intercalating gefitinib

• pemetrexed/cisplatin

Locations

Country	Name	City	State
China	The first affiliated hospital of Guangzhou MC	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease progression-free survival	the last patient into group for three years or dead	3 years
Secondary	overall survival	the last patients into group for 5 years or dead	5 years
Secondary	side-effects	the last patient into group for 3 years or dead	3 years
Secondary	overall response rate	the last patient into group for 3 years or dead	3 years