Phase
Condition
N/ATreatment
Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Understand the requirements and contents of the clinical trial, and provide a signedand dated informed consent form.
Age ≥ 18 years.
Histologically or cytologically confirmed, Stage IV NSCLC.
EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory,progressed from first line systematic therapy.
ECOG 0-1.
Predicted survival ≥ 12 weeks.
Adequate bone marrow hematopoiesis and organ function
Presence of measurable lesions according to RECIST 1.1.
Exclusion
Exclusion Criteria:
Cancer-Specific Exclusions:
Active or untreated central nervous system metastases.
Malignancies other than NSCLC within 5 years prior to randomization, with theexception of those with a negligible risk of metastasis or death treated withexpected curative outcome.
General Medical Exclusions:
Pregnant or lactating women.
History of autoimmune disease.
History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-inducedpneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screeningchest computed tomography scan. History of radiation pneumonitis in the radiationfield (fibrosis) is permitted.
Positive test for human immunodeficiency virus.
Active hepatitis B or hepatitis C.
Severe infection within 4 weeks prior to randomization.
Significant cardiovascular disease.
Illness or condition that interferes with the participant's capacity to understand,follow and/or comply with study procedures.
Exclusion Criteria Related to Medications:
• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.
Study Design
Study Description
Connect with a study center
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaActive - Recruiting
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