Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 89
Inclusion Criteria
- Male or female outpatients (except where inpatient stay is required for medical need at the Investigator's discretion) at least 18 years of age at the time of informed consent
- Life expectancy of at least 3 months
- Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
- ...
- Male or female outpatients (except where inpatient stay is required for medical need at the Investigator's discretion) at least 18 years of age at the time of informed consent
- Life expectancy of at least 3 months
- Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Eligibility for platinum-based chemotherapy
- Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
- History of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
- Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
- ...
- Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
- History of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
- Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
- Other protocol defined exclusion criteria could apply
- Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
- In countries where EGFR TKIs are available for the treatment of NSCLC, subjects need to have been screened for EGFR mutations and excluded if positive, unless previously treated and progressed on an appropriate TKI therapy
- In countries where anaplastic lymphoma kinase (ALK) inhibitors are available for the treatment of NSCLC, subjects need to have been screened for ALK fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (TKI) therapy
- Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
Summary
- Conditions
- Carcinoma Non-small-cell Lung
- Carcinoma, Non-Small-Cell Lung
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Male or female outpatients (except where inpatient stay is required for medical need at the Investigator's discretion) at least 18 years of age at the time of informed consent
- Life expectancy of at least 3 months
- Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
- ...
- Male or female outpatients (except where inpatient stay is required for medical need at the Investigator's discretion) at least 18 years of age at the time of informed consent
- Life expectancy of at least 3 months
- Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Eligibility for platinum-based chemotherapy
- Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
- Other protocol defined inclusion criteria could apply
Exclusion Criteria
- Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
- History of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
- Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
- ...
- Previous investigational drug or any anticancer therapy in the 30 days (or 5 half-lives for non-cytotoxics, whichever is shorter) prior to the start of trial treatment
- History of any other malignancy within 5 years (except basal cell carcinoma of the skin or carcinoma in situ of the cervix)
- Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
- Other protocol defined exclusion criteria could apply
- Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
- In countries where EGFR TKIs are available for the treatment of NSCLC, subjects need to have been screened for EGFR mutations and excluded if positive, unless previously treated and progressed on an appropriate TKI therapy
- In countries where anaplastic lymphoma kinase (ALK) inhibitors are available for the treatment of NSCLC, subjects need to have been screened for ALK fusion gene rearrangements and excluded if positive, unless previously treated and progressed on an appropriate tyrosine kinase inhibitor (TKI) therapy
- Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
Tracking Information
- NCT #
- NCT02083679
- Collaborators
- Not Provided
- Investigators
- Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
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