This is a multi-center observational study of atezolizumab combination therapy in patients with unresectable, advanced and recurrent non-small cell lung cancer(NSCLC) or extensive disease small cell lung cancer(ED-SCLC). 800 patients in NSCLC cohort and 400 patients in ED-SCLC cohort will be enrolled in this trial to assess the efficacy and safety of this combination.
Primary endpoint: 12 months OS, Secondary endpoints: Overall Survival(OS), 6 months survival rate(6mo OS), 12 months survival rate(12mo OS), Progression-Free Survival(PFS), Time to treatment failure (TTF), Objective Response Rate(ORR), Disease Control Rate(DCR), Duration of Response(DOR) ,Safety and Comprehensive geriatric assessment(G8)
Study Type
OBSERVATIONAL
Enrollment
1,221
12 months survival rate
Percentage of participants alive 12 months after initiation of treatment
Time frame: Baseline up to 12 Months
Overall Survival
OS was defined as the time from the first day of study treatment to death due to any cause
Time frame: Up to death (up to 3 years)
6 moths survival rate
Percentage of participants alive 6 months after initiation of treatment
Time frame: Up to 6 months
18 moths survival rate
Percentage of participants alive 18 months after initiation of treatment
Time frame: Up to 18 months
Progression-Free Survival(PFS)
PFS based on disease status as evaluated by the investigator in accordance with Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 (v1.1)
Time frame: Up to disease progression or death whichever occurs first (up to 3 years)
Time to treatment failure (TTF)
TTF was defined as the time from the first day of study treatment to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient preference, or death
Time frame: Up to 3 years
Post-treatment transfer rate
Rate of patients who received drug therapy for primary disease after study treatment
Time frame: Up to post-treatment is started (up to 3 years)
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Akashi Medical Center
Akashi, Japan
Hyogo Cancer Center
Akashi, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Japan
Asahikawa Medical University Hospital
Asahikawa, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Japan
Juntendo University Hospital
Bunkyō City, Japan
Nippon Medical School Hospital
Bunkyō City, Japan
Tokyo Medical And Dental University, Medical Hospital
Bunkyō City, Japan
Chiba University Hospital
Chiba, Japan
National Cancer Center Hospital
Chūōku, Japan
...and 138 more locations
Objective Response Rate(ORR)
Percentage of participants with objective response as assessed by the investigator according to RECIST v1.1
Time frame: Up to disease progression or death whichever occurs first (up to 3 years)
Duration of Response(DOR)
Duration of Response as Assessed by the Investigator According to RECIST v1.1
Time frame: From date of first objective response up to disease progression or death whichever occurs first (up to 3 years)
Disease Control Rate(DCR)
Percentage of patients with controled disease as Assessed by the investigator according to RECIST v1.1
Time frame: Up to 3 years
Percentage of Participants with adverse events(Adverse Reactions)
The incidence of worst-grade adverse events on study as graded by NCI-CTCAE v5.0
Time frame: Up to 3 years
Comprehensive geriatric assessment (G8)
The G-8 screening tool was developed to identify elderly cancer patients who would benefit from comprehensive geriatric assessment
Time frame: At baseline