Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients (NCT05636267) | Clinical Trial Compass
TerminatedPhase 1/2
Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients
Stopped: Terminated due to sponsor strategic development reprioritization.
China59 participantsStarted 2023-02-10
Plain-language summary
This is a phase Ib/II study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AK119 and AK112 With or Without Chemotherapy for NSCLC patients.
Who can participate
Age range
18 Years – 75 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
. Be able to understand and voluntarily sign the written informed consent, which must be signed before the designated research procedure.
. Age ≥ 18 and ≤ 75, male or female.
. Local advanced or metastatic non-squamous NSCLC confirmed by histology or cytology according to eighth edition of the TNM classification for lung cancer.
. EGFR activating mutation confirmed by tumor histology, cytology or hematology.
. Failed to previous EGFR-TKI treatment.
. ECOG performance status 0 to1.
. Life expectancy ≥3 months.
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.
What they're measuring
1
Number of subjects with dose limiting toxicities (DLTs)
Timeframe: During the first 3 weeks
2
Number of subjects with adverse events (AEs)
Timeframe: From the time of informed consent signed through 90 days after the last dose of study drug
. At least one measurable lesion according to RECIST v1.1.
Exclusion criteria
. Histological or cytological pathology confirmed the presence of small cell carcinoma or squamous cell carcinoma.
. Have suffered from the second primary active malignant tumor in the past 3 years.
. There are other driving gene mutations that can obtain effective treatment.
. Receipt of the following treatments or procedures: immunotherapy, including immunocheckpoint inhibitors, immunocheckpoint agonists, immunocellular therapy, and any other treatment targeting tumor immune mechanism; systematic chemotherapy in the advanced stage (IIIB-IV); anti-angiogenesis drugs, except for small molecule anti-angiogenesis drugs with drug withdrawal more than 4 weeks; extensive radiotherapy within 4 weeks; EGFR-TKIs within 2 weeks.
. Symptomatic central nervous system metastases.
. The toxicity of previous anti-tumor therapy has not been alleviated.
. Uncontrolled massive ascites, pleural effusion or pericardial effusion.