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:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT04263051
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Age ≥ 18 years
* Histologically or cytologically confirmed advanced NSCLC (adenocarcinoma, squamous cell carcinoma, large cell carcinoma, undifferentiated carcinoma or other)
* Advanced NSCLC cancer patient with progressive disease after a first line of combo chemotherapy plus anti-PD-1 or chemotherapy plus anti-PD-L1 combination
* Measurable disease defined according to iRECIST v1.1 guidelines
* Patients must have a mandatory treatment-free interval of at least 21 days following previous systemic anti-cancer treatments
* Patients who have received previous systemic anticancer treatment and/or radiotherapy should have recovered from any treatment related toxicity, to a level of ≤ grade 1 with the exception of Grade 2 alopecia
* Performance status 0 or 1 on the ECOG scale
* Females must be using highly effective contraceptive measures and have a negative pregnancy test prior to the start of dosing if of childbearing potential, or must have evidence of non-childbearing potential. Females of childbearing potential should use reliable methods of contraception from the time of the screening until 5 months after discontinuing study treatment. Male patients with a female partner of childbearing potential should be willing to use barrier contraception during the study and for 7 months following discontinuation of study drug. Patients should refrain from donating sperm from the start of dosing until 7 months after discontinuing study treatment.
* Registration in a national health care system.
* Ability to comply with the study protocol, in the Investigator's judgment
Exclusion Criteria:
* Diagnosis of additional malignancy within 2 years prior to the inclusion with the exception of curatively treated basal cell carcinoma of the skin and/or curatively resected in situ cervical or breast cancer
* Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
* Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatment
* Patient under guardianship, curatorship or under the protection of justice
* Uncontrolled tumor-related pain
* Uncontrolled pleural effusion, pericardial effusion, ascites or symptomatic fistula
* Known active central nervous system metastases and/or carcinomatous meningitis
* Uncontrolled brain metastases
* Presence of EGFR mutation, ALK or ROS1 translocation
* history of hyperprogression during first line treatment with chemotherapy plus immunotherapy
* Inadequate organ functions: known cardiac failure of unstable coronaropathy, respiratory failure, or uncontrolled infection or another life-risk condition
* Active or chronic hepatitis B or C and/or HIV positive or known history of active Covid-19 infection, or a known history of active Tuberculosis bacillus
* Any immunosuppressive therapy (i.e. corticosteroids \>10mg of hydrocortisone or equivalent dose) within 14 days before the planned start of study therapy
* Active autoimmune disease that has required a systemic treatment in past 2 years (i.e. corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin) is allowed
* Active or history of autoimmune disease or immune deficiency
* Prior allogeneic bone marrow transplantation or prior solid organ transplantation
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
* Known hypersensitivity or allergy to Chinese hamster ovary cell products or any component of Nivolumab formulation
* History of idiopathic or secondary pulmonary fibrosis or evidence of active pneumonitis requiring a systemic treatment with 28 days before the planned start of study therapy
* Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
* Treatment with therapeutic oral or IV antibiotics within 4 weeks prior to initiation of study treatment
* Receipt of a live, attenuated vaccine within 4 weeks prior to the initiation of treatment or anticipation that such a live, attenuated vaccine will be required during the study
* Patients requiring oxygen therapy
* For patients with a known cardiac history or with cardiac events occurring after first-line chemoimmunotherapy: LEVF\<40% ; troponin \> ULN; BNP \> ULN
* Inadequate hematology, hepatic, renal functions or others inadequate laboratory values
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04263051
Study Brief:
Protocol Section:
NCT04263051