UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042333
Receipt number R000048326
Scientific Title Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer
Date of disclosure of the study information 2021/03/01
Last modified on 2023/07/02 22:47:27

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Basic information

Public title

Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer

Acronym

Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer

Scientific Title

Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer

Scientific Title:Acronym

Multicenter Retrospective Study to Evaluate Docetaxel plus Ramucirumab after Combination Therapy with PD-1 Inhibitor and Chemotherapyin Advanced Non-Small Cell Lung Cancer

Region

Japan


Condition

Condition

non-small cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To verify the effects and prognosis of docetaxel/ramucirumab secondary therapy following combination therapy with programmed cell death 1 (PD-1) inhibitor and chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Best response
Last date of survival confirmation/date of death

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

99 years-old >

Gender

Male and Female

Key inclusion criteria

1. The patients had received anti-PD-1/L1 antibody + chemotherapy (+bevacizumab) as the primary therapy, followed by secondary therapy with docetaxel/ramucirumab starting by August 31, 2020.
2. Patients aged 20 years or older

Key exclusion criteria

Patients judged by the principal investigator of each institution to be inappropriate for registration

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Ou
Middle name
Last name Yamaguchi

Organization

Saitama Medical University International Medical Center

Division name

respiratory medicine

Zip code

350-1298

Address

1397-1 Yamane, Hitaka City, Saitama Prefecture

TEL

042-984-4111

Email

ouyamagu@saitama-med.ac.jp


Public contact

Name of contact person

1st name Ou
Middle name
Last name Yamaguchi

Organization

Saitama Medical University International Medical Center

Division name

respiratory medicine

Zip code

350-1298

Address

1397-1 Yamane, Hitaka City, Saitama Prefecture

TEL

042-984-4111

Homepage URL


Email

ouyamagu@saitama-med.ac.jp


Sponsor or person

Institute

Saitama Medical University International Medical Center

Institute

Department

Personal name



Funding Source

Organization

Eli Lilly Japan

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

IRB, Saitama Medical University International Medical Center

Address

1397-1 Yamane, Hitaka City, Saitama Prefecture

Tel

042-984-4523

Email

chikens@saitama-med.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

2021 Year 03 Month 01 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/36905770/

Number of participants that the trial has enrolled

288

Results

The ORR and DCR of RD were 28.8% (95% CI, 23.7-34.4) and 69.8% (95% CI, 64.1-75.0), respectively. Median PFS was 4.1 months (95% CI, 3.5-4.6); median OS was 11.6 months (95% CI, 9.9-13.9). Univariate and multivariate Cox regression analysis of OS showed that bone metastases at diagnosis, poor PS (2-3), and non-adenocarcinoma were independent poor prognostic factors.

Results date posted

2023 Year 07 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

222 (77.1%) were male, 262 (91.0%) were under 75 years old, 199 (69.1%) had adenocarcinoma, 236 (81.9%) had stage III/IV, 52 (18.1%) had postoperative recurrence, 42 (14.6%) had pleural effusion, 40 (13.9%) had brain, 34 (11.8%) liver, 97 (33.7%) bone metastases, and 3 (1.0%) had interstitial lung disease. PD-L1 was measurable in 264 patients, of whom 123 (46.6%) were negative for PD-L1 expression. 56.3%, followed by pembrolizumab plus paclitaxel/nab-paclitaxel plus platinum (20.1%). Taxanes and bevacizumab were also used in combination in 32.6% and 12.8% of patients, respectively, for first-line therapy. 60 mg/m2 of docetaxel (DTX) was the highest dose in RD (93.8%). 19 patients (6.6%) had PS 2-3 included at the start of RD. In addition, 223 patients (77.4%) received prophylactic pegfilgrastim from the first cycle of RD.

Participant flow

288 patients who received anti-PD-1/L1 antibody + platinum-based chemotherapy as first-line treatment and RD as second-line treatment at 62 centers in Japan between January 2017 and August 31, 2020.

Adverse events

Hematologic toxicities included febrile neutropenia in 12.2%. Non-hematologic toxicities included pneumonitis of all grades in 10.8% and grade 3 or higher in 4.9%.

Outcome measures

Anti-tumor effect (ORR, DCR), overall survival (OS), progression-free survival (PFS), time to treatment failure (TTF), adverse events, etc.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2020 Year 07 Month 01 Day

Date of IRB

2021 Year 01 Month 13 Day

Anticipated trial start date

2021 Year 03 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Multicenter Retrospective Study


Management information

Registered date

2020 Year 11 Month 03 Day

Last modified on

2023 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048326


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name