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Report for Clinical Trial NCT03706287

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Efficacy and Safety of Anlotinib Combined With Platinum Plus Pemetrexed in T790M Mutation Negative Metastastic Non-squamous Non-small-cell Lung Cancer After Progression on First-line EGFR TKI: a Phase II, Muti-center, Single Arm Study

This study is conducted to explore the safety and efficacy of anlotinib, a tyrosine kinase inhibitors of vascular endothelial growth factor receptor 2(VEGFR)、FGFR(fibroblast growth factor receptor), platelet-derived growth factor receptor(PDGFR) and tumor cell proliferation related kinase c-Kit, combined with platinum plus pemetrexed in T790M mutation negative metastatic non-squamous non-small cell lung cancer(NSCLC) after the failure of EGFR-TKI.

NCT03706287 Lung Cancer Metastatic
MeSH:Lung Neoplasms
HPO:Neoplasm of the lung

4 Interventions

Name: anlotinib 8mg + AP/PC

Description: anlotinib 8mg/d, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
Type: Drug
Group Labels: 1

Anlotinib + AP/PC

Name: anlotinib 10mg + AP/PC

Description: anlotinib 10mg/d, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
Type: Drug
Group Labels: 1

Anlotinib + AP/PC

Name: anlotinib 12mg + AP/PC

Description: anlotinib 12mg/d, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
Type: Drug
Group Labels: 1

Anlotinib + AP/PC

Name: anlotinib + AP/PC

Description: anlotinib doses to be determined following the completion of Phase I of the study, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
Type: Drug
Group Labels: 1

Anlotinib + AP/PC


Primary Outcomes

Description: PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.

Measure: Progression-free survival (PFS)

Time: Up to 24 months

Description: Dose Limiting Toxicity (DLT) is referred to grade 3 non-hematological toxicity or grade 4 hematological toxicity according to NCI CTCAE 4.03 criteria

Measure: Dose limiting toxicity (DLT)

Time: Estimated about 6 months

Description: Maximum Tolerance Dose (MTD) is the dose of treatment in the cohort where there are 2 cases of DLT reported.

Measure: Maximum tolerance dose (MTD)

Time: Estimated about 6 months

Secondary Outcomes

Description: To determine ORR of Anlotinib Anlotinib combined with Platinum-based Pemetrexed in T790M mutation negative Advanced NSCLC. ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.

Measure: Objective response rate(ORR)

Time: Up to 24months

Description: Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.

Measure: Disease Control Rate (DCR)

Time: Up to 24months

Description: Defined as the the time from first confirmed CR or PR until the first date of either objective disease progression or death due to any cause.

Measure: Duration of Response (DOR)

Time: Up to 24months

Description: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Measure: Safety (Number of Participants with Adverse Events as a Measure of Safety and Tolerability)

Time: Until 21 day safety follow-up visit

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

- Epidermal Growth Factor Receptor(EGFR)mutations confirmed by molecular detection (including, but not limited to 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - Patients have only be treated with EGFR -TKIs(Tyrosine kinase inhibitors)including gefitinib, elotinib or icotinib, and received a best response of PR for ≥4months or SD for 6 months; disease has progressed recently according to RECIST 1.1 and negative for T790M detection(detection methods including ddPCR, ARMS or NGS) (For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment) - Must have at least one measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter imaged by CT scan or MRI;prior topical treatment, such as radiotherapy cryosurgery to the lesions is not allowed in less than 3 months; - Life expectancy ≥3 months. --- L858R ---


2 T790M

Efficacy and Safety of Anlotinib Combined With Platinum Plus Pemetrexed in T790M Mutation Negative Metastastic Non-squamous Non-small-cell Lung Cancer After Progression on First-line EGFR TKI: a Phase II, Muti-center, Single Arm Study. --- T790M ---

Efficacy and Safety of Anlotinib Plus Platinum Plus Pemetrexed in T790M-negative NSCLC This study is conducted to explore the safety and efficacy of anlotinib, a tyrosine kinase inhibitors of vascular endothelial growth factor receptor 2(VEGFR), FGFR(fibroblast growth factor receptor), platelet-derived growth factor receptor(PDGFR) and tumor cell proliferation related kinase c-Kit, combined with platinum plus pemetrexed in T790M mutation negative metastatic non-squamous non-small cell lung cancer(NSCLC) after the failure of EGFR-TKI. --- T790M ---

Efficacy and Safety of Anlotinib Plus Platinum Plus Pemetrexed in T790M-negative NSCLC This study is conducted to explore the safety and efficacy of anlotinib, a tyrosine kinase inhibitors of vascular endothelial growth factor receptor 2(VEGFR), FGFR(fibroblast growth factor receptor), platelet-derived growth factor receptor(PDGFR) and tumor cell proliferation related kinase c-Kit, combined with platinum plus pemetrexed in T790M mutation negative metastatic non-squamous non-small cell lung cancer(NSCLC) after the failure of EGFR-TKI. --- T790M --- --- T790M ---

To determine ORR of Anlotinib Anlotinib combined with Platinum-based Pemetrexed in T790M mutation negative Advanced NSCLC. --- T790M ---

- Epidermal Growth Factor Receptor(EGFR)mutations confirmed by molecular detection (including, but not limited to 19 exon deletion and L858R) external pathological examination was accepted (including pathological or blood test results) - Patients have only be treated with EGFR -TKIs(Tyrosine kinase inhibitors)including gefitinib, elotinib or icotinib, and received a best response of PR for ≥4months or SD for 6 months; disease has progressed recently according to RECIST 1.1 and negative for T790M detection(detection methods including ddPCR, ARMS or NGS) (For recurrent patients, adjuvant chemotherapy, neoadjuvant chemotherapy or neoadjuvant chemotherapy plus adjuvant were assessed for eligibility, and the last treatment time must be more than 6 months before enrollment) - Must have at least one measurable lesion as per RECIST 1.1 defined as a lesion that is 10mm in longest diameter imaged by CT scan or MRI;prior topical treatment, such as radiotherapy cryosurgery to the lesions is not allowed in less than 3 months; - Life expectancy ≥3 months. --- L858R --- --- T790M ---

Phase II is to designed to explore the anti-tumor activity of anlotinib combined with platinum plus pemetrexed in T790M mutation negative metastatic non-squamous non-small cell lung cancer(NSCLC) after the failure of EGFR-TKI. --- T790M ---



HPO Nodes


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