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Report for Clinical Trial NCT01310036

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

An Open-Label Multicenter Study of Erlotinib (Tarceva®) as First Line Therapy Until and Beyond RECIST Progression in NSCLC Patients Who Harbour EGFR Mutations

This open-label, single arm study will evaluate the safety and efficacy of Tarceva (erlotinib) as first-line therapy in participants with stage IV or recurrent non-small cell lung cancer who harbour epidermal growth factor receptor (EGFR) mutations. All participants will receive Tarceva 150 mg daily orally until disease progression or unacceptable toxicity occurs. At the investigator's discretion, participants may receive Tarceva beyond disease progression.

NCT01310036 Non-Squamous Non-Small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

1 Interventions

Name: Erlotinib

Description: Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.
Type: Drug
Group Labels: 1

Erlotinib


Primary Outcomes

Description: PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

Measure: Progression-free Survival Per RECIST, v. 1.1 (PFS1)

Time: Approximately 68 months

Secondary Outcomes

Description: PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.

Measure: Progression-free Survival Per Investigator (PFS2)

Time: Approximately 68 months

Description: ORR was defined as the occurrence of either a confirmed complete (CR) or a partial response (PR, as a best overall response), as determined by RECIST, v. 1.1 criteria. CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Measure: Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R

Time: Approximately 68 months

Description: DCR was defined as CR + PR + Stable disease (SD). CR was defined as disappearance of all target lesions. PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

Measure: Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R

Time: Approximately 68 months

Description: PFS1 was defined as time from first dose until documented progressive disease (PD), assessed per Response Evaluation Criteria in Solid Tumors RECIST, v. 1.1, or death from any cause, whichever occurred first. PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.

Measure: Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1)

Time: Approximately 68 months

Description: OS was defined as the time from baseline to the date of death from any cause.

Measure: Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R

Time: Approximately 68 months

Description: An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not considered related to the study drug.

Measure: Number of Participants With Adverse Events

Time: Approximately 68 months

Description: This outcome measure was not assessed.

Measure: Correlation Between EGFR Mutations in Plasma and Clinical Outcome (ORR/PFS/OS)

Time: Approximately 68 months

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There are 2 SNPs

SNPs


1 L858R

PFS2 was defined as time from first study dose to off-erlotinib progressive disease (PD), assessed by the investigator based on overall clinical evaluation.. Objective Response Rate (ORR) for All Participants and Participants With EGFR Mutation E19del or L858R. --- L858R ---

PR was defined as least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.. Disease Control Rate (DCR) for All Participants and Participants With EGFR Mutation E19del or L858R. --- L858R ---

PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.. Progression-free Survival for Participants With EGFR Mutation E19del or L858R Per RECIST, v. 1.1 (PFS1). --- L858R ---

PD was defined as: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline; an absolute increase of at least 5 mm in the sum of diameters of target lesions; and the appearance of one or more new lesions.. Overall Survival (OS) for All Participants and Participants With EGFR Mutation E19del or L858R. --- L858R ---


2 T790M

This outcome measure was not assessed.. Inclusion Criteria: - Adult participants, >/= 18 years of age - Stage IV or recurrent non-small cell lung cancer (NSCLC) - Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only) - Measurable disease (at least one lesion >= 10 mm in longest diameter) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Adequate hematological, renal and liver function Exclusion Criteria: - Patients with T790M single mutation only - Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. --- T790M ---

This outcome measure was not assessed.. Inclusion Criteria: - Adult participants, >/= 18 years of age - Stage IV or recurrent non-small cell lung cancer (NSCLC) - Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only) - Measurable disease (at least one lesion >= 10 mm in longest diameter) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Adequate hematological, renal and liver function Exclusion Criteria: - Patients with T790M single mutation only - Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. --- T790M --- --- T790M ---

erlotinib, gefitinib, cetuximab, trastuzumab - Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease - Symptomatic or uncontrolled central nervous system (CNS) metastases - Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast - Any significant ophthalmologic abnormality - Pre-existing parenchymal lung disease such as pulmonary fibrosis - Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead) Inclusion Criteria: - Adult participants, >/= 18 years of age - Stage IV or recurrent non-small cell lung cancer (NSCLC) - Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only) - Measurable disease (at least one lesion >= 10 mm in longest diameter) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Adequate hematological, renal and liver function Exclusion Criteria: - Patients with T790M single mutation only - Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. --- T790M ---

erlotinib, gefitinib, cetuximab, trastuzumab - Prior chemotherapy or systemic anti-cancer therapy for advanced NSCLC disease - Symptomatic or uncontrolled central nervous system (CNS) metastases - Other malignancy within the last 5 years, except for carcinoma in situ of the cervix, or basal or squamous cell carcinoma of the skin, or surgically treated localized prostate cancer, or surgically treated ductal cell carcinoma in situ of the breast - Any significant ophthalmologic abnormality - Pre-existing parenchymal lung disease such as pulmonary fibrosis - Use of coumarins (for anti-coagulation therapy the use of low molecular weight heparin is recommended instead) Inclusion Criteria: - Adult participants, >/= 18 years of age - Stage IV or recurrent non-small cell lung cancer (NSCLC) - Presence of mutation(s) in exon 18 through exon 21 of epidermal growth factor receptor (EGFR), (except T790M single mutation only) - Measurable disease (at least one lesion >= 10 mm in longest diameter) - Eastern Cooperative Oncology Group (ECOG) performance status 0-2 - Adequate hematological, renal and liver function Exclusion Criteria: - Patients with T790M single mutation only - Prior exposure to agents directed at the human epidermal receptor (HER) axis, e.g. --- T790M --- --- T790M ---



HPO Nodes


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