Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
NCT ID:
NCT04205812
Eligibility Criteria:
Inclusion Criteria:
* Histologically or cytologically confirmed NSCLC (either nonsquamous or squamous) that is Stage IV (AJCC v8).
* No prior systemic treatment for the advanced/metastatic NSCLC
* Able to provide a formalin-fixed archival tumor tissue sample during screening, or a fresh tumor biopsy
* Measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 months.
* Willingness to avoid pregnancy or fathering children.
* Adequate organ function as indicated by protocol-specified laboratory values. - Has been fully vaccinated against SARS-CoV-2 or is willing and able to be fully vaccinated against SARS-CoV-2 during the study by starting the vaccination process during screening.
Exclusion Criteria:
* Clinically significant cardiac disease within 6 months of start of study treatment.
* Any major surgery within 3 weeks of the first dose of study treatment.
* Thoracic radiation therapy of \> 30 Gy within 6 months of the first dose of study treatment.
* History of peripheral neuropathy ≥ Grade 2 CTCAE v5 for participants who may receive cisplatin, paclitaxel, or nab-paclitaxel.
* Untreated central nervous system metastases and/or carcinomatous meningitis.
* Evidence or history of interstitial lung disease or noninfectious pneumonitis that required systemic steroids.
* Active infection requiring systemic therapy or active tuberculosis. Note: If required by country or local regulations to be tested for COVID-19 during screening, a participant should be excluded if they have a positive test result for SARS CoV-2 infection until both the retesting result is negative and clinical recovery is obtained.
* Superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers.
* Has contraindications to chemotherapy agents used in the study.
* Has an active autoimmune disease that has required systemic treatment in past 2 years.
* Is receiving systemic antibiotics or steroid therapy ≤ 7 days prior to the first dose of study treatment.
* Has received a live vaccine within 30 days before the first dose of study treatment (and until 90 days after last dose of study drug).
Note: While based on approved SARS-CoV-2 vaccines available worldwide, many vaccines are not live (mRNA and adenovirus vaccines do not contain live virus), if a live vaccine against SARS-CoV-2 is the only available option, prior consultation with the medical monitor should be obtained.
• Has known active HBV or HCV (testing must be performed to determine eligibility)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04205812
Study Brief:
Protocol Section:
NCT04205812