Recruitment

Recruitment Status
Terminated
Estimated Enrollment
89

Inclusion Criteria

Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
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
...
Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
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
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
Eligibility for platinum-based chemotherapy
Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
Other protocol defined inclusion criteria could apply
Life expectancy of at least 3 months

Exclusion Criteria

Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
Other protocol defined exclusion criteria could apply
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
...
Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
Other protocol defined exclusion criteria could apply
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
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)
Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
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

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

Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
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
...
Measurable disease defined as 1 or more target lesions according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
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
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
Eligibility for platinum-based chemotherapy
Tumor tissue available for epidermal growth factor receptor (EGFR) expression analysis
Other protocol defined inclusion criteria could apply
Life expectancy of at least 3 months

Exclusion Criteria

Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
Other protocol defined exclusion criteria could apply
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
...
Concurrent chronic immunosuppressive or hormone anticancer therapy (except other physiologic hormone replacement)
Other protocol defined exclusion criteria could apply
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
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)
Known brain metastases (unless asymptomatic and treated) or leptomeningeal metastases, including suspected leptomeningeal spread with positive cytology
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

Tracking Information

NCT #
NCT02083679
Collaborators
Not Provided
Investigators
Study Director: Medical Responsible Merck KGaA, Darmstadt, Germany
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