Pemetrexed/Cisplatin Intercalating Gefitinib Treating EGFR Wild NSCLC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2021-12-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

pemetrexed/cisplatin intercalating gefitinib

Intervention Type DRUG

pemetrexed/cisplatin

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

Group Type ACTIVE_COMPARATOR

pemetrexed/cisplatin

Intervention Type DRUG

Interventions

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pemetrexed/cisplatin intercalating gefitinib

Intervention Type DRUG

pemetrexed/cisplatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No