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A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer

A Phase III, Randomized, Double-blinded, Multicenter Study of AK105 Combined With Carboplatin and Paclitaxel vs Placebo Combined With Carboplatin and Paclitaxel as First-line Therapy in Patients With Metastatic Squamous Non-small Cell Lung Cancer

NCT03866993•Akeso

View on ClinicalTrials.gov

Summary

This is a phase III, randomized, double-blinded, multicenter clinical study to evaluate the efficiency and safety of AK105 (Anti-PD1 antibody) plus paclitaxel and carboplatin vs placebo plus paclitaxel and carboplatin as First-line Therapy in patients with metastatic squamous non-small cell lung cancer.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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 ICF.
•Eastern Cooperative Oncology Group (ECOG) performance score 0 or 1.
•Expected life expectance ≥ 3 months.
•Histologically or cytologically confirmed diagnosis of stage IV squamous 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 \< 6 months prior to first dose of study treatment.
•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.
+1 more criteria

Exclusion Criteria

•Subjects who are diagnosed as NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.
•Subjects with other histological types of NSCLC, including mixed squamous cell carcinoma and adenocarcinoma, and mixed carcinoma containing small cell lung carcinoma or neuroendocrine carcinoma.
•Received prior treatment with EGFR inhibitors or ALK inhibitors.
•Receipt of last radiotherapy or any anti-tumor treatment \[chemotherapy, targeted therapy, immunotherapy, Chinese patent drugs with antitumor indications, or immunomodulators or tumor embolization\] within 3 weeks prior to the first dose of study treatment.
•Prior exposure to any anti-PD-1, anti-PD-L1, anti-CTLA-4 antibody, or any other antibody or drug therapy for T cell co-stimulatory or checkpoint pathways, such as ICOS or agonists (e.g. CD40, CD137, GITR and OX40 etc).
•Other invasive malignancies within 5 years, except for locally treatable (manifested as cured) malignancies, such as basal or skin squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ.
•Subjects with active, known or suspected autoimmune disease, or a medical history of autoimmune disease, with the exceptions of the following: vitiligo, alopecia, Grave disease, psoriasis or eczema not requiring systemic treatment within the last 2 years, hypothyroidism (caused by autoimmune thyroiditis) only requiring steady doses of hormone replacement therapy and type I diabetes only requiring steady doses of insulin replacement therapy, or completely relieved childhood asthma that requires no intervention in adulthood, or primary diseases that will not relapse unless triggered by external factors.
•Active or previously documented inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis or chronic diarrhea).
•Subjects who require systemic corticosteroids (a dose equivalent to \>10 mg/day prednisone) or other immunosuppressive drugs within 14 days prior to the first dose of study drug.
•Major surgery (as defined by the investigator) within 28 days prior to the first dose of study drug.
+21 more criteria

Locations (2)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Chinese PLA General Hospital

Beijing, China

Key Dates

Start Date

December 20, 2018

Primary Completion Date

October 8, 2020

Completion Date

January 14, 2022

Last Updated

April 3, 2024

Enrollment

350

ACTUAL participants

Conditions

Lung Cancer Non-small Cell Stage IVSquamous Cell Lung Cancer

Interventions

AK105

BIOLOGICAL

Paclitaxel

DRUG

Carboplatin

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Anti-PD-1 AK105 in Patients With Metastatic Squamous Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

A Study of ZEN003694 in People With Squamous Cell Lung Cancer

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