Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

Guangzhou Medical University

Status and phase: Unknown; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: pemetrexed/cisplatin intercalating gefitinib; Drug: pemetrexed/cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT03374280

GuangzhouMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

pemetrexed/cisplatin intercalating gefitinib

Experimental group

Description:

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

Treatment:

Drug: pemetrexed/cisplatin intercalating gefitinib

pemetrexed/cisplatin

Active Comparator group

Description:

pemetrexed 500mg/m2 d1; cisplatin 30mg/m2 d1-2 to 4 cycles. pemetrexed 500mg/m2 d1 to disease progression or untolerable

Treatment:

Drug: pemetrexed/cisplatin