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Report for Clinical Trial NCT01746277

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase Ⅱ Randomized Controlled Trial to Compare Chemotherapy Sequenced by EGFR-TKIs and Chemotherapy Combined With EGFR-TKIs for Advanced or Metastatic NSCLC Patients Failed to EGFR-TKIs Therapy

There are two different treatment modes for NSCLC patients who failed to epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) after initially responding to EGFR-TKI. One is EGFR-TKI combined with chemotherapy and the other is chemotherapy followed by EGFR-TKI. It is unclear which one is more suitable to this group of lung cancer patients. So this phase Ⅱclinical trial is designed to compare the efficiency and safety of these two different treatment modes.

NCT01746277 Non Small Cell Lung Cancer
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

2 Interventions

Name: combined group

Description: chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycle is 6 depending on disease evaluation and patient's physical condition combined with gefitinib 250mg once per day from the start day of chemotherapy until disease progression or intolerable side effects.

Type: Drug

combined group

Name: Sequenced group

Description: sequenced group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycles is 6 depending on disease evaluation or patient's physical condition sequenced by gefitinib 250mg once per day until disease progression or intolerable side effects.

Type: Drug

sequenced group


Primary Outcomes

Description: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 52 weeks.

Measure: progression free survival

Time: up to 52 weeks (about one year)

Secondary Outcomes

Description: From date of randomization until the date of death from any cause, assessed up to 100 weeks.

Measure: overall survival

Time: up to 100 weeks

Description: The objective response rate includes the complete remission and partial remission rate.

Measure: objective response rate

Time: up to 9 weeks

Description: FACL-L is assessed at different time points.(Date of randomization,1 week after chemotherapy,every cycle of chemotherapy,every month of EGFR-TKI maintain treatment,up to 100 weeks)

Measure: the score of functional assessment of cancer treatment-lung(FACT-L)

Time: up to 100weeks

Description: The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria(version3.0) (NCI-CTC).

Measure: Number of participants with adverse events

Time: Participants will be followed for the duration of treatment, an expected average of 52 weeks.

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 L858R

The adverse events are assessed by National Cancer Institute-Common Toxicity Criteria(version3.0) (NCI-CTC).. Inclusion Criteria: - age ≥ 18 years - histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable) - clinical stages ⅢB or Ⅳ - recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy - partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment - at least one bidimensionally measurable or radiographically assessable lesion - Eastern cooperative oncology group performance status (ECOG PS) ≤ 2 - life expectancy ≥ 12 weeks - adequate hematological, renal, and hepatic functions Exclusion Criteria: - additional malignancies - uncontrolled systemic disease - any evidence of clinically active interstitial lung disease - newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery - pregnancy or breast feeding phase Inclusion Criteria: - age ≥ 18 years - histologically and cytologically proven non-small cell bronchogenic carcinoma (sputum cytology alone was not acceptable) - clinical stages ⅢB or Ⅳ - recurrent or refractory disease following previous first-line chemotherapy regimens containing platinum and second-line EGFR-TKIs therapy - partial remission (PR) or stable disease (SD) at least for 6 months during previous EGFR-TKI treatment - at least one bidimensionally measurable or radiographically assessable lesion - Eastern cooperative oncology group performance status (ECOG PS) ≤ 2 - life expectancy ≥ 12 weeks - adequate hematological, renal, and hepatic functions Exclusion Criteria: - additional malignancies - uncontrolled systemic disease - any evidence of clinically active interstitial lung disease - newly diagnosed central nervous system (CNS) metastasis and not treated by radiotherapy or surgery - pregnancy or breast feeding phase Non Small Cell Lung Cancer Carcinoma, Non-Small-Cell Lung Responses to EGFR-TKIs are quiet dramatic and durable, especially in patients with EGFR gene classic mutations, such as 19 deletion or 21 leucine 858 arginine(L858R). --- L858R ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 3
TP53 TP53 BAP1