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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03071705
Date of registration:	01/03/2017
Prospective Registration:	No
Primary sponsor:	Instituto Nacional de Cancerologia de Mexico
Public title:	Metformin Plus TKI Use in Patients With Non-Small Cell Lung Carcinoma
Scientific title:	Effect of Metformin in Combination With Tyrosine Kinase Inhibitors (TKI) on Clinical, Biochemical and Nutritional in Patients With Non-Small Cell Lung Carcinoma (NSCLC): Randomized Clinical Trial
Date of first enrolment:	March 2016
Target sample size:	120
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03071705
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
Phase:	N/A

Countries of recruitment
Mexico

Contacts

Name:	Oscar Gerardo MD Arrieta, Oncology
Address:
Telephone:	015556280400
Email:	ogar@servidor.unam.mx
Affiliation:

Name:	Oscar Arrieta, MD, MSc
Address:
Telephone:	01 55 5628 0400
Email:	ogar@servidor.unam.mx
Affiliation:

Name:	Oscar Arrieta, MD, MSc
Address:
Telephone:
Email:
Affiliation:	Instituto Nacional de Cancerología

Key inclusion & exclusion criteria

Inclusion Criteria:

- NSCLC EGFR mutation-positive

- Use of only Metformin as oral hypoglucemic agent

- ECOG-PS 0-2

- Measurable disease

- Life expectancy >12 weeks

Exclusion Criteria:

- Systemic disease

- Patients with TKI treatment longer than 2 months

- History of other neoplasm in the past 5 years

- Breastfeeding women

Age minimum: 18 Years
Age maximum: 99 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tyrosine Kinase Mutation

Non-Small Cell Adenocarcinoma

EGFR Gene Mutation

Intervention(s)

Drug: TKI

Drug: Metformin

Primary Outcome(s)

Overall Survival [Time Frame: Start of treatment until 1-year follow-up]

Secondary Outcome(s)

Response Rate [Time Frame: 3 month evaluation after start of treatment]

Secondary ID(s)

016/018/ICI

Ethics Committe

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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