A Phase Ib Study of GC101 in NSCLC (NCT06473961) | Clinical Trial Compass
RecruitingPhase 1
A Phase Ib Study of GC101 in NSCLC
China20 participantsStarted 2024-10-14
Plain-language summary
20 participants are expected to be enrolled for the Phase Ib clinical trial，this trail is expected to be finished in 36 months.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 unresectable advanced, recurrent, or metastatic non-small cell lung cancer who are positive for driver genes and have failed after targeted and platinum-containing dual 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 as defined by the following laboratory test results, the test results must be completed and issued within 7 days before tumor tissue collection:
* White Blood Cell (WBC)≥2.5×10\^9/L#
* Absolute Lymphocyte Count (ANC)≥1.5×10\^9/L;
* Absolute Lymphocyte Count(ALC)≥0.7×10\^9/L;
* Platelet≥100×10\^9/L#
* International Normalized Ratio#INR#≤1.5×ULN;
* Activated Partial Thromboplastin Time#APTT#≤1.5×ULN;
* Serum Creatinine (Scr)≤1.5mg/dL (or 132.6μmol/L) or Creatinine
* Clearance≥60mL/min
* Urinalysis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.