UMIN-CTR Clinical Trial

Public title

The combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with advanced non-small-cell lung cancer harboring EGFR mutations: a phase 2 trial.

Acronym

Pemetrexed and continued EGFR-TKIs beyond progressive disease in elderly patients with EGFR-mutant advanced NSCLC.

Scientific Title

The combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with advanced non-small-cell lung cancer harboring EGFR mutations: a phase 2 trial.

Scientific Title:Acronym

Pemetrexed and continued EGFR-TKIs beyond progressive disease in elderly patients with EGFR-mutant advanced NSCLC.

Region

Japan

Condition

non-small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the efficacy and safety of combination therapy of pemetrexed and continued EGFR-TKIs beyond disease progression to first-line EGFR-TKIs treatments in elderly patients with EGFR-mutant advanced NSCLC.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Disease control rate

Key secondary outcomes

Progression free survival, overall survival, adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

The combination therapy of pemetrexed and continued EGFR-TKIs in elderly patients with EGFR-mutant advanced NSCLC that has developed acquired resistance to EGFR-TKIs is assessed.

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

Age-lower limit

75

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

All participants must meet the following criteria.
1: Histologically or pathologically proven non-squamous NSCLC.
2: Stage 3B, 4, or recurrence.
3: EGFR mutation positive.
4: Previously treated with EGFR-TKIs more than 8 weeks effectively (SD,PR, or CR), then acquired resistance.
5: Radiographically measurable lesion.
6: Age 75 years or older.
7: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2.
8: No major organ system dysfunction.
a. White blood cell count: more than 3,000/uL.
b. Neutrophil cell count: more than 1500/uL.
c. Hemoglobin: more than 9.0 g/dL.
d. Platelet count: more than 100,000/uL.
e. Aspartate transaminase (AST), alanine transaminase(ALT): less than 2.5 times the upper limit of normal of the institutional reference range.
f. Total bilirubin: less than 1.5 times the upper limit of normal of the institutional reference range.
g. Creatinine: less than 1.2 mg/dL.
h. Creatinine clearance: more than 45 ml/min.
i. SpO2: more than 90%.
9: No interstitial lung disease.
10: Life expectancy of more than 3 months.
11: Written informed.

Key exclusion criteria

Exclusion criteria are as follows
1: Symptomatic brain metastasis.
2: History of radiotherapy to primary lesion.
3: Severe and unstable medical comorbidities.
4: Difficulty in ingestion.
5: With third-space fluid to be drained.
6: Pregnant or breastfeeding women. Willing to get pregnant.
7: Contraindication for taking EGFR-TKIs.
8: Active double cancers.
9: History of severe allergy to drugs.
10: Judgment to attending physician.

Target sample size

22

Name of lead principal investigator

1st name
Middle name
Last name	Takafumi Suda

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan

TEL

053-435-2111

Email

suda@hama-med.ac.jp

Name of contact person

1st name
Middle name
Last name	Yusuke inoue

Organization

Hamamatsu University School of Medicine

Division name

Second Division, Department of Internal Medicine

Zip code

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu-city, Japan

TEL

053-435-2111

Homepage URL

Email

y.inoue@hama-med.ac.jp

Institute

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine

Institute

Department

Personal name

Organization

Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

06

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Terminated

Date of protocol fixation

2013

Year

04

Month

30

Day

Date of IRB

Anticipated trial start date

2013

Year

06

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

06

Month

12

Day

Last modified on

2016

Year

06

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012800