A Phase II Study of GC101 in NSCLC (NCT07560111) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II Study of GC101 in NSCLC
28 participantsStarted 2026-06-01
Plain-language summary
28 participants are expected to be enrolled for the Phase II clinical trial, this trial is expected to be finished in 36 months.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* 1\. Signed the informed consent form (ICF) and able to comply with the visits and related procedures specified in the protocol;
* 2\. Aged ≥18 years and ≤70 years, regardless of gender;
* 3.Patients with non-small cell lung cancer who have been confirmed negative for EGFR mutations, ALK, and ROS-1 by prior genetic testing, meeting one of the following criteria:(1) If the patient is known to carry one or more other actionable genetic mutations (e.g., KRAS G12C mutation, BRAF V600 mutation, MET exon 14 skipping mutation, HER-2 mutation, RET fusion, NTRK fusion), the patient must have received at least one approved targeted therapy, and the investigator considers that additional targeted therapy would not be in the best interest of the study participant. In addition, the patient must have experienced failure of platinum-based chemotherapy.
* 4\. TILs can be isolated from a surgically resectable tumor region: the tissue volume must be \>150mm3, and the lesion has not received local treatment (such as radiotherapy, radiofrequency ablation, oncolytic virus, etc.) or progressed after local treatment;
* 5\. There are still at least 1 measurable lesion (according to RECIST1.1 criteria \[see Appendix 4\]) even after TIL sampling and resection of surgically resectable tissue;
* 6\. ECOG performance status 0-1;
* 7\. Expected survival time \>3 months;
* 8\. With sufficient hematology and end-organ function
* 9.\* Premenopausal women who have not undergone steriliza…