Lung Cancer Clinical Trials

• Participants who are at least 18 years of age on the day of signing informed consent,

• All participants must understand spoken and written national language,

• Histologically confirmed diagnosis of NSCLC (adenocarcinoma versus squamous cell carcinoma versus others)

• Have metastatic or unresectable NSCLC and considered by their physician to be indicated for a new line of immunotherapy.

• Have an Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 2. Evaluation of ECOG-PS is to be performed within 7 days prior to the date of treatment allocation.

• Patients who have progressed after immunotherapy or immunotherapy plus platinum-based chemotherapy (with platinum-based chemotherapy and ICI either sequentially or concomitantly).

• Have received ATB within 60 days before and 42 days after the first ICI administration and have progressed within 6 months after the first ICI.

• There are no restrictions on the number of prior lines of treatment. Patients may be included regardless of the number of previous therapies received.

• A male participant must abstain from heterosexual activity or must agree to use a contraception as detailed below (or in Appendix 2 of this protocol) during the treatment period and for at least 9 months after the last dose of CB or BIC and refrain from donating sperm during this period. (In application of the new recommendations of the CTFG)

⁃ A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and if at least one of the following conditions applies:

∙ Not a woman of childbearing potential (WOCBP) as defined in Appendix 2.

‣ A WOCBP should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. A WOCBP must agree to follow the contraceptive guidance in Appendix 2 or abstain from heterosexual activity during the treatment period and for at least 180 days, after the last dose of treatment.

⁃ Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.

⁃ Patients must be affiliated to a social security system or beneficiary of the same

⁃ Have an estimated life expectancy greater than 3 months (from inclusion).

⁃ Meet acceptable steroid dose thresholds (i.e., not above the acceptable threshold \<10 mg prednisone daily or equivalent) if receiving systemic steroids at physiologic doses

⁃ Have measurable disease based on RECIST 1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

⁃ Have adequate organ function as defined in the Table 1. All screening laboratory tests must be performed within 28 days prior to the start of study treatment.