A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NCT04647344) | Clinical Trial Compass
CompletedPhase 1/2
A Study of AK104 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
China46 participantsStarted 2020-11-24
Plain-language summary
This is a phase Ib/II , open-label, multicenter single arm study designed to evaluate the efficacy, safety, tolerability, pharmacokinetic (PK), and immunogenicity of AK104 combined with Carboplatin and Pemetrexed/ Paclitaxel as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Signed written informed consent form voluntarily.
* Age over 18 years old (inclusive) and not more than 75 years old (inclusive), when signing the informed consent form.
* Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
* Expected life expectance ≥ 3 months.
* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC.
* No prior systemic chemotherapy for advanced or metastatic NSCLC. Subjects who have received prior adjuvant chemotherapy or neoadjuvant chemotherapy with curative intent, or definitive chemoradiotherapy for advanced disease, will be eligible provided that progression has occurred \>6 months from last treatment.
* At least one measurable tumor lesion per RECIST 1.1 criteria. A lesion previously irradiated will not be considered a target lesion.
* Subjects must provide an available tumor tissue sample taken \< 1 year prior to first dose of study treatment.
* Subjects must provide wild-type epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) reported by tissue-based tests(for non-squamous NSCLC subjects only).
* Adequate organ function.
* Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception.
* nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective method of contraception from Day 1 and for 120 days aft…
What they're measuring
1
The number of subjects experiencing adverse events (AEs) (Phase Ib)
Timeframe: From the time of informed consent through 90 days following termination of treatment with investigational product
2
Objective response rate (ORR) assessed by investigator