A Phase II Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC

STATUS

Recruiting
End date

Jan 27, 2024
participants needed

206
sponsor

Akeso

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Updated on 27 October 2022

See if I qualify

paclitaxel

measurable disease

pemetrexed

carboplatin

docetaxel

cancer chemotherapy

Summary

This is a phase II study. All patients are stage IIIB/C or IV non-small cell lung cancer(NSCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of AK112 in combination with chemotherapy in patients with NSCLC.

Details

Condition	NSCLC
Treatment	docetaxel, carboplatin, Paclitaxel, Pemetrexed, AK105, AK112
Clinical Study Identifier	NCT04736823
Sponsor	Akeso
Last Modified on	27 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	to 75 years old (at the time of inform consent obtained)
	Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures)
	Have histologically- or cytologically-confirmed diagnosis of Stage IIIB/C or IV NSCLC
	Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy
	Have a life expectancy of at least 3 months
	Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
	Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator
	Has adequate organ function
	All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment
Exclusion Criteria
	Is currently participating in a study of an investigational agent or using an investigational device
	Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy within 2 years prior to the first dose of study treatment
	Has undergone major surgery within 30 days prior to the first dose of study treatment
	Has a known history of prior malignancy except that basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
	Has known active central nervous system (CNS) metastases
	Has carcinomatous meningitis
	Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment NOTE: Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study
	Has an active infection requiring systemic therapy
	Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected)
	History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment
	Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of this subject to participate, in the opinion of the treating investigator
	Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
	Has received a live virus vaccine within 30 days prior to first dose of study treatment
	Is pregnant, breastfeeding, or expecting to conceive or father a child within the projected duration of the study including 120 days following the last dose of study treatment

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A Phase II Trial of AK112 (PD1/VEGF Bispecific) in Combination With Chemotherapy in Patients With NSCLC