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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07423169
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent
2. Biopsy proven unresectable lung adenocarcinoma
3. Ineligibility for surgery and conventional curative (whole tumor) radiotherapy, and relapsed/refractory to any previous standard of care therapy including ICI
4. Age ≥ 18 years,
5. Female patients must either be of non-reproductive potential (i.e. post-menopausal by history: ≥60 years old and no menses for ≥1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) OR women of fertile age must have adequate conception prevention measures and must have a negative serum pregnancy test upon study entry,
6. Patient is willing and able to comply with the follow up including scheduled visits and examinations,
7. Adequate immune blood profile (not being immunodepressed): Leucocyte count ≥4000, Neutrophils count ≥1000.
8. PDL-1 ≥ 1%
Exclusion Criteria:
1. Patients with resectable/curable lung cancer
2. Tumors suitable for the standard of care therapies including surgery or conventional curative (whole tumor) radio-chemotherapy
3. Lung cancer histology other than adenocarcinoma
4. Female patients who are pregnant, breast-feeding or male or female patients of reproductive potential who are not employing an effective method of birth control
5. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, (1)
6. Patients with uncontrolled seizures.
7. Inadequate immune blood profile (being potentially immunodepressed): Leucocyte count \<4000, Neutrophils count \<1000.
8. PDL-1 \< 1%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07423169
Study Brief:
Protocol Section:
NCT07423169