Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC

Exclusion Criteria

• •Are currently undergoing other anti-tumor therapies or have concurrent active cancer.
• •Patients who were enrolled into any other treatment clinical trial and received treatment on that trial within 4 weeks of study treatment.
• •Any clinical laboratory findings give reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
• •Patients with previously untreated brain metastases should be excluded. Patients with treated and stable (\>4 weeks) brain metastases may be eligible for enrollment.
• •History of allergic reactions to carboplatin or paclitaxel.
• •Have had immunotherapy or radiotherapy within 4 weeks prior to study treatment or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to study treatment. Prior history of palliative radiation for symptomatic bony or brain metastases is permissible.
• •Are receiving any other investigational agents.
• •Patients with known ROS1 mutations who have not received prior targeted therapy.
• •Alcohol or drug dependence.
• •Uncontrolled coagulopathy.
• •Uncontrolled hyper- or hypothyroidism.
• •Known hypersensitivity to pirfenidone, carboplatin, pemetrexed or paclitaxel.
• •Pre-existing peripheral neuropathy of Grade II or higher.
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III/IV), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• •Patients receiving any medications or substances that are moderate to strong inhibitors CYP1A2 are ineligible.
• •Pregnant women are excluded from this study. Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study drug administration.