UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057827 |
|---|---|
| Receipt number | R000065965 |
| Scientific Title | An Observational Study Comparing the Efficacy of Carboplatin + Nab-paclitaxel + Atezolizumab and Platinum-based Chemotherapy + Pemetrexed + Pembrolizumab in Patients With TTF-1 Negative Advanced Non-squamous Non-small Cell Lung Cancer |
| Date of disclosure of the study information | 2025/05/12 |
| Last modified on | 2025/05/11 00:04:11 |
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Basic information
Public title
An Observational Study Comparing the Efficacy of Carboplatin + Nab-paclitaxel + Atezolizumab and Platinum-based Chemotherapy + Pemetrexed + Pembrolizumab in Patients With TTF-1 Negative Advanced Non-squamous Non-small Cell Lung Cancer
Acronym
Observational Study Comparing Two Regimens in TTF-1 Negative Advanced Non-squamous NSCLC
Scientific Title
An Observational Study Comparing the Efficacy of Carboplatin + Nab-paclitaxel + Atezolizumab and Platinum-based Chemotherapy + Pemetrexed + Pembrolizumab in Patients With TTF-1 Negative Advanced Non-squamous Non-small Cell Lung Cancer
Scientific Title:Acronym
Observational Study Comparing Carboplatin + Nab-paclitaxel + Atezolizumab and Platinum-based Chemotherapy + Pemetrexed + Pembrolizumab in TTF-1 Negative Advanced Non-squamous NSCLC
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the optimal chemotherapy plus immune checkpoint inhibitor regimen for TTF-1-negative non-squamous non-small cell lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
progression-free survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who have been registered in one of the following previous studies targeting TTF-1 negative advanced NSCLC and have received treatment with either Carboplatin + Nab-paclitaxel + Atezolizumab or Platinum-based chemotherapy + Pemetrexed + Pembrolizumab. These patients must have evaluable efficacy based on treatment results.
i) Phase II Trial of Carboplatin + Nab-paclitaxel + Atezolizumab Combination Therapy for TTF-1 Negative Advanced Non-squamous NSCLC (F1NE-TUNE)
ii) Multicenter Observational Study to Evaluate the Efficacy of Platinum-based Chemotherapy + Pemetrexed + Pembrolizumab in TTF-1 Negative Advanced Non-squamous NSCLC (KN189 Observational Study)
(2) PS of 0-1.
(3) Patients must meet one of the following conditions:
(i) Stage III or IV NSCLC that is not amenable to curative radiation therapy.
(ii) Post-surgical recurrence.
(iii) Recurrence after curative radiation therapy to the trunk, with at least 168 days having passed since the last radiation session.
(4) No previous systemic chemotherapy. Patients with no history of systemic pharmacological therapy for the cancer under investigation in this study. However, patients who have had recurrence after chemoradiation therapy are eligible if at least 168 days have passed since the last chemotherapy dose or the last chest radiation therapy. Furthermore, postoperative UFT treatment history is acceptable for registration regardless of the elapsed time from the last dose (excluding the drugs mentioned in Note 1).
Note 1: Drugs targeting T-cell co-stimulation or checkpoint pathways, such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.
(5) No history of chemotherapy using the drugs listed in Note 1 for other cancer types.
(6) The following criteria must be met for driver gene testing:
i) Negative for EGFR gene mutations.
ii) Negative or unknown for ALK fusion gene, ROS1 fusion gene, BRAF V600E mutation, MET exon 14 skipping mutation, RET fusion gene, or NTRK fusion gene.
Key exclusion criteria
(1) Patients with evident interstitial pneumonia identified on CT imaging.
(2) Patients with a current autoimmune disease or a history of autoimmune disease that required steroid therapy.
(However, patients with autoimmune-related hypothyroidism who are receiving a stable dose of thyroid hormone replacement therapy, or patients with well-controlled type 1 diabetes receiving a stable insulin regimen, are eligible.)
(3) Patients with serious comorbidities.
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Kohei |
| Middle name | |
| Last name | Otsubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Respiratory Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926425378
otsubo.kohei.231@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kohei |
| Middle name | |
| Last name | Otsubo |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Respiratory Medicine
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
TEL
0926425378
Homepage URL
otsubo.kohei.231@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research of Kyushu University Hospital and Medical Institutions
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka, Japan
Tel
092-642-5082
ijkseimei@jimu.kyushu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Data to be Collected]
Information on age, sex, performance status (PS), height, weight, and medical history (including smoking history, past medical history, and comorbidities); clinical stage; number of metastatic organs and presence or absence of adrenal, brain, and bone metastases at diagnosis; driver gene alterations; date of treatment initiation; treatment regimen; histological type of the tumor and results of immunohistochemistry including TTF-1; and clinical course including treatment history (progression-free survival, overall survival, sites of distant metastases, number and details of treatment cycles, and best overall response to treatment), among others.
Management information
Registered date
| 2025 | Year | 05 | Month | 11 | Day |
Last modified on
| 2025 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065965
