Sym004 in Subjects With Stage IV Non-small Cell Lung Cancer
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 89
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Other protocol defined inclusion criteria could apply
- Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
- ...
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Other protocol defined inclusion criteria could apply
- Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
- Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
- Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- Life expectancy of at least 3 months
- Eligibility for platinum-based chemotherapy
- 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
Exclusion Criteria
- Other protocol defined exclusion criteria could apply
- 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)
- ...
- Other protocol defined exclusion criteria could apply
- 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)
- 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
- Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Other protocol defined inclusion criteria could apply
- Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
- ...
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
- Other protocol defined inclusion criteria could apply
- Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
- Histologically-confirmed NSCLC Stage IV disease (according to the seventh edition of the lung cancer staging system)
- Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
- Life expectancy of at least 3 months
- Eligibility for platinum-based chemotherapy
- 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
Exclusion Criteria
- Other protocol defined exclusion criteria could apply
- 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)
- ...
- Other protocol defined exclusion criteria could apply
- 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)
- 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
- Previous therapy for Stage IV NSCLC, or neo- or adjuvant chemotherapy or chemoradiotherapy within the previous 6 months
- 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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