Skip to content

Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)

Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study) - Cohort study for investigating treatment reality in resectable and unresectable stage III non-small-cell lung carcinoma populations in Japan (SOLUTION study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000031385
Enrollment
1000
Registered
2018-02-20
Start date
2018-03-13
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage III non-small cell lung cancer

Interventions

None listed

Sponsors

AstraZeneca K.K
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [1st cohort] 1.Patients giving written informed consent to participate in this study (for patients who have died or been lost to follow up, the instructions of the ERB in each medical institution [e.g., general consent and opt-out] should be followed) 2.Male or female patients aged 20 years or older at the time of diagnosis of stage III NSCLC 3.Patients diagnosed with unresectable stage III NSCLC between January 1 2013 and December 31 2015 4.Patients who were received curative chemoradiotherapy including platinum (the patients diagnosed as unresectable who were received the salvage surgery after chemoradiotherapy are eligible) [2nd cohort] 5.Patients giving written informed consent to participate in this study (for patients who have died or been lost to follow up, the instructions of the ERB in each medical institution [e.g., general consent and opt-out] should be followed) 6.Male or female patients aged 20 years or older at the time of diagnosis of stage III NSCLC 7.Patients diagnosed with stage III NSCLC between January 1 2013 and December 31 2014 8.Patients who were received any aggressive treatment without supportive care or no treatment

Exclusion criteria

Exclusion criteria: 1. Patients receiving unapproved drugs for the treatment of NSCLC at the initiation of this study 2. Patients who are regarded as inappropriate to participate in the study by the primary investigators

Design outcomes

Primary

MeasureTime frame
[1st cohort] 1.To estimate OS in the overall cohort population [2nd cohort] 2.To estimate OS in the overall cohort population

Secondary

MeasureTime frame
[1st cohort] 1.To estimate PFS in the overall cohort populations and OS and PFS by treatment regimen 2.To estimate ORR and TTDM in the overall cohort populations and by treatment regimen 3.To evaluate safety profile of treatment for patients with stage III NSCLC in terms of treatment-related adverse events including pneumonitis/radiation pneumonitis 4.To summarize treatment outcomes stratified by clinical characteristics [2nd cohort] 5.To summarize the patient characteristics at initial diagnosis in overall cohort population and in type of initial treatments 6.To estimate OS, PFS, and DFS (in case of surgery) in type of initial treatment 7.To estimate ORR and TTDM in type of initial treatment, without surgery 8.To evaluate safety profile of treatment for patients with stage III NSCLC in terms of treatment-related adverse events including pneumonitis/radiation pneumonitis 9.To summarize treatment outcomes stratified by clinical characteristics

Countries

Japan

Contacts

Public ContactSatomi Kohata

A2 Healthcare Corporation Clinical Research Department

SOLUTION@a2healthcare.com03-3830-1075

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026