Study of Atezolizumab in Combination With Cabozantinib Versus Docetaxel in Patients With Metastatic Non-Small Cell Lung Cancer Previously Treated With an Anti-PD-L1/PD-1 Antibody and Platinum-Containing Chemotherapy

JRCT ID: jRCT2051200065

Registered date:14/10/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Non small cell lung cancer
• Date of first enrollment: 05/01/2021
• Target sample size: 350
• Countries of recruitment: Australia,Japan,Austria,Japan,Belgium,Japan,France,Japan,Germany,Japan,Greece,Japan,Italy,Japan,Republic of Korea,Japan,Poland,Japan,Portugal,Japan,Russia,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Atezolizumab:Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
Cabozantinib:Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.
Docetaxel:Docetaxel will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.

Outcome(s)

Primary Outcome

efficacy
overall survival

Secondary Outcome

safety,efficacy,phamacokinetics
progression-free survival etc
Observation/Inspection, RECIST v1.1

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

-Histologically or cytologically confirmed metastatic NSCLC
-Documented radiographic disease progression during or following treatment with platinum-containing chemotherapy and anti-PD-L1/PD-1 antibody, administered concurrently or sequentially for metastatic NSCLC
-Measurable disease per RECIST v1.1 outside CNS as assessed by investigator
-Known PD-L1 status or availability of tumor tissue for central PD-L1 testing
-ECOG Performance Status score of 0 or 1
-Recovery to baseline or Grade <=1 NCI CTCAE v5.0 from toxicities related to any prior treatments, unless adverse events are clinically nonsignificant and/or stable on supportive therapy in the opinion of the investigator
-Adequate hematologic and end-organ function
-Negative HIV test at screening
-Negative hepatitis B surface antigen (HBsAg) test at screening
-Negative total hepatitis B core antibody (HBcAb) test at screening, or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening
-Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
-For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
-For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.

Exclude criteria

-Prior therapy with the following agents for NSCLC: Cabozantinib, Docetaxel, Combination of an anti-PD-L1/PD-1 antibody concurrently with a vascular endothelial growth factor (VEGF)R targeting tyrosine kinase inhibitor (TKI)
-Treatment with investigational therapy within 28 days prior to initiation of study treatment
-Documentation of known sensitizing mutation in the EGFR gene or ALK fusion oncogene
-Symptomatic, untreated, or actively progressing CNS metastases
-History of leptomeningeal disease
-Uncontrolled tumor-related pain
-Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (more frequently than once monthly)
-Uncontrolled or symptomatic hypercalcemia
-Any other active malignancy at the time of initiation of study treatment or diagnosis of another malignancy within 3 years prior to initiation of study treatment that requires active treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, incidental prostate cancer, or carcinoma in situ of the prostate, cervix, or breast
-Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
-Stroke, transient ischemic attack, myocardial infarction or other symptomatic ischemic events within 6 months of initiation of study treatment
-Active tuberculosis
-Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
-Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
-Current treatment with anti-viral therapy for HBV
-Major surgical procedure, other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
-Pregnant or lactating females, or intention of becoming pregnant during the treatment with atezolizumab in combination with cabozantinib in the experimental arm or during the treatment with docetaxel in the control arm, or within 5 months after the final dose of atezolizumab and/or 4 months after the final dose of cabozantinib, whichever is later.

Related Information

• Primary Sponsor: Clinical trials information
• Secondary ID(s): NCT04471428