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 range18 Years – 75 Years
SexALL
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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.
✓. 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.
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