Chemotherapy and Erlotinib for Lung Cancer With Low Abundance Epidermal Growth Factor Receptor Mutation

NCT ID: NCT02095782

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-01-20

Brief Summary

This is a single arm phase II clinical trial, which aims to evaluate the effectiveness of intercalated combination of doublet chemotherapy of paclitaxel plus carboplatin and erlotinib on patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation.

Detailed Description

Primary therapy stage:

Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.

Maintenance therapy stage:

Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.

Conditions

Non-small-cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy and erlotinib

Intercalated combination of chemotherapy and erlotinib in 1st line setting for patients with advanced stage non-small-cell lung cancer with low abundant activating EGFR mutation

Group Type: EXPERIMENTAL

Intercalated combination of chemotherapy and erlotinib

Intervention Type: DRUG

Primary therapy stage:

Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.

Maintenance therapy stage:

Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.

Interventions

Intercalated combination of chemotherapy and erlotinib

Primary therapy stage:

Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.

Maintenance therapy stage:

Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death.

Intervention Type: DRUG

Other Intervention Names

paclitaxel plus carboplatin and targeted therapy erlotinib

Eligibility Criteria

Inclusion Criteria

Low abundant activating EGFR mutation: EGFR exon 19 deletion or exon 21 L858R, which are positive by real-time PCR methods and negative by standard sequencing methods.

Uncommon EGFR mutations are included excluding exon 20 mutations. ECOG performance status of ≤ 2. Patients can administer first line setting of platinum based chemotherapy. Patients must have measurable disease according to the RECIST (version 1.1) criteria.

• Life expectancy of at least 12 weeks.
• Age ≥ 18 years.
• Written (signed) informed Consent to participate in the study.
• Adequate organ function as defined by the following criteria:

Liver function: SGOT (AST) and SGPT (ALT) ≤ 2.5 X ULN in the absence of liver metastases or up to 5 X ULN in case of liver metastases. Total bilirubin ≤ 1.5ULN.

Bone marrow function: Granulocyte count ≥ 1,500/mm3 and platelet count ≥100,000/mm3 and hemoglobin ≥90g/dl.

Renal function: serum creatinine ≤ 1.5 ULN or creatinine clearance ≥ 60 ml/min. (based on modified Cockcroft-Gault formula).

• For all females of childbearing potential a negative serum/urine pregnancy test must be obtained within 48 hours before enrollment. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential.

Exclusion Criteria

• Patients with history of any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
• Patients who have brain metastasis or spinal cord compression. It is permitted if the patient has been treated with surgery and/or radiation with evidence of stable disease for at least 4 weeks.
• Patients who are at risk (in the investigator's opinion) of transmitting human immunodeficiency virus (HIV) through blood or other body fluids.
• Nursing or lactating women.
• Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
• Unwilling to write informed consent to participate in the study.
• Patients who is unwilling to accept the follow-up.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Association of Clinical Trials

OTHER

Sponsor Role: lead

Responsible Party

Yi-Long Wu

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yi-Long Wu

Role: STUDY_CHAIR

Guangdong General Hospital (GGH)& Guangdong Academy of Medical Sciences

Zhen Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

Guangdong General Hospital & Guangdong Academy of Medical Sciences

Locations

Guangdong General Hospital & Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

CTONG1307

Identifier Type: -

Identifier Source: org_study_id