SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02098954

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Second Line Erlitinib Combination With Gemcitabine Cisplatinum in Non-small Cell Lung Cancer Patients Who Harbored EGFR Sensitive Mutation Developed Resistance After First Line TKI Treatment

Numerous evidences verified that erlotinib could dramatically improve the PFS and OS of non-small cell lung cancers who harbor EGFR sensitive mutations, however, primary or secondary resistance will be developed after TKI treatment, doctors do plenty of researches to overcome TKI resistance. FAST ACT-2 study present that, first line erlotinib combined with chemotherapy could improved mOS to more than 30 months in NSCLCs who harbor EGFR sensitive mutations, several study shows that sensitive mutations still exist after TKI resistance, because of the next generation TKIs(such as BIBW2992) are not avaliable at present, agents for met amplification(such as Crizotinib) are so expensive that many Chinese patients could not support. Thus, the investigators hypothesis that, after first line TKI treatment, the patients who developed TKI resistance could still benefit from second line TKI combined with chemotherapy.

NCT02098954 Carcinoma, Non-Small Cell Lung EGFR Gene Mutation
MeSH: Carcinoma, Non-Small-Cell Lung
HPO: Non-small cell lung carcinoma

1 Interventions

Name: Gemcitabine platinum combined with erlotinib

Description: patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycles combined chemotherapy, patients will receive erlotinib for maintain treatment until progression disease.Gemcitabine for day 1 and day 8, 1250mg/m2. Platinum for day 1, 75mg/m2. Erlotinib for day 9-21 during combined chemotherapy, 150mg/day, then erlotinib should be used daily until patients develop progression disease.

Type: Drug

experimental


Primary Outcomes

Description: mean progression free survival(mPFS) will be recorded in enroll patients who received second line gemcitabine platinum combined with erlotinib. mPFS should be measured before second line treatment, before the third combined chemotherapy, after the fourth combined chemotherapy, every 3 months during erlotinib treatment, mPFS should be measured up to two years or every time progression disease occurs within two years.

Measure: mean progression free survival(mPFS)

Time: after patients receive treatment, mPFS should be measured before the third cycle of chemotherapy, after the fourth cycle, mPFS should be measured every 3 months up to two years

Secondary Outcomes

Description: mOS should be measured since enrollment, every 3 months we will contact patients to find out detail survival data of each patient until 3 years, or within 3 years if all survival data is obtained.

Measure: mean overall survival(mOS)

Time: every 3 months up to 3 years, or until all the survival data is obtained

Description: 8 week ORR should be measured after enrollment, after combined chemotherapy for 8 weeks, the exact time point should be the ninth week during combined chemotherapy. CR, PR, SD shoud be measured according to RESICT 1.1

Measure: 8 week overall response rate(8 week ORR)

Time: 8 week ORR should be measured after enrollment, the exact time point should be the ninth week after combined chemotherapy

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 L858R

Inclusion Criteria: - advanced non-small cell lung cancer, stage IIIB/IV - non-squamous - EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R - received first line TKIs treatment and developed TKI resistance - ECOG 0-2 Exclusion Criteria: - squamous non-small cell lung cancer - patients have unstable brain metastasis, predict survival less than 8 weeks - spinal-cord compression without evidence of stabilisation or treatment - women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline - patients have any unstable illness that could not receive further treatment Inclusion Criteria: - advanced non-small cell lung cancer, stage IIIB/IV - non-squamous - EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R - received first line TKIs treatment and developed TKI resistance - ECOG 0-2 Exclusion Criteria: - squamous non-small cell lung cancer - patients have unstable brain metastasis, predict survival less than 8 weeks - spinal-cord compression without evidence of stabilisation or treatment - women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline - patients have any unstable illness that could not receive further treatment Carcinoma, Non-Small Cell Lung EGFR Gene Mutation Carcinoma, Non-Small-Cell Lung The investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with EGFR TKI sensitive mutations and developed TKI resistance in first line treatment. --- L858R ---

Inclusion Criteria: - advanced non-small cell lung cancer, stage IIIB/IV - non-squamous - EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R - received first line TKIs treatment and developed TKI resistance - ECOG 0-2 Exclusion Criteria: - squamous non-small cell lung cancer - patients have unstable brain metastasis, predict survival less than 8 weeks - spinal-cord compression without evidence of stabilisation or treatment - women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline - patients have any unstable illness that could not receive further treatment Inclusion Criteria: - advanced non-small cell lung cancer, stage IIIB/IV - non-squamous - EGFR sensitive mutations, such as exon 19 del, or exon 21 L858R - received first line TKIs treatment and developed TKI resistance - ECOG 0-2 Exclusion Criteria: - squamous non-small cell lung cancer - patients have unstable brain metastasis, predict survival less than 8 weeks - spinal-cord compression without evidence of stabilisation or treatment - women who were pregnant or lactating; women with a positive or no available pregnancy test result at baseline - patients have any unstable illness that could not receive further treatment Carcinoma, Non-Small Cell Lung EGFR Gene Mutation Carcinoma, Non-Small-Cell Lung The investigators will enroll patients diagnosed with advanced non-squamous,non-small cell lung cancer, patients with EGFR TKI sensitive mutations and developed TKI resistance in first line treatment. --- L858R --- --- L858R ---



HPO Nodes


HPO:
Non-small cell lung carcinoma
Genes 2
TP53 BAP1