๐ฌIn plain words
What the trial is, and whether it could suit you
The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age โฅ 18 years.
3. Histologically or cytologically confirmed, Stage IV NSCLC.
4. EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
5. ECOG 0-1.
6. Predicted survival โฅ 12 weeks.
7. Adequate bone marrow hematopoiesis and organ function
8. Presence of measurable lesions according to RECIST 1.1.
Exclusion Criteria:
Cancer-Specific Exclusions:
* Active or untreated central nervous system metastases.
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
General Medical Exclusions:
* Pregnant or lactating women.
* History of autoimmune disease.
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (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:
โข Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.