Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

G

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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

Trial contacts and locations

1

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Central trial contact

Hailing Yang, MD; Fengnan Wang, MD

Data sourced from clinicaltrials.gov

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