Trial Outcomes & Findings for Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) (NCT NCT02019979)

NCT ID: NCT02019979

Last Updated: 2018-05-04

Results Overview

Progress Free Survival (PFS) is defined as the time from the date of the first dose of treatment to the earlier of the dates of first disease progression per RECIST 1.1 or death from any cause.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 14 participants
• Primary outcome timeframe: Time after day 1 cycle 1 to first disease progression for up to 20 months
• Results posted on: 2018-05-04

Participant Flow

Recruitment began in December 2013 with enrollment from Jan 2014 to April 2016 at 3 sites. 17 initially enrolled, but 3 came off study prior to beginning therapy and not included in analysis.

Participant milestones

Measure	Metformin /Carbohydrate Restricted Diet metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
Overall Study STARTED	14
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Measure	Metformin /Carbohydrate Restricted Diet metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
Overall Study study terminated	14

Baseline Characteristics

Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC)

Baseline characteristics by cohort

Measure	Metformin /Carbohydrate Restricted Diet n=14 Participants metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
Age, Continuous	66.71 years STANDARD_DEVIATION 6.24 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Time after day 1 cycle 1 to first disease progression for up to 20 months

Progress Free Survival (PFS) is defined as the time from the date of the first dose of treatment to the earlier of the dates of first disease progression per RECIST 1.1 or death from any cause.

Outcome measures

Measure	Metformin /Carbohydrate Restricted Diet n=14 Participants metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
Progress Free Survival	3.9 months Interval 0.33 to 16.17

SECONDARY outcome

Timeframe: up to 30 months

Overall survival (OS) is defined as time from date of first dose to date of death from any cause.

Outcome measures

Measure	Metformin /Carbohydrate Restricted Diet n=14 Participants metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
Overall Survival	11.7 months Interval 0.33 to 28.9

SECONDARY outcome

Timeframe: 6 months

To evaluate LKBI mutations as a potential bio-marker to predict subjects who will benefit most from metformin in combination with a carbohydrate restricted diet

Outcome measures

Measure	Metformin /Carbohydrate Restricted Diet n=14 Participants metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
Number of Participants With LKBI Mutation	0 Participants

Adverse Events

Metformin /Carbohydrate Restricted Diet

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Metformin /Carbohydrate Restricted Diet n=14 participants at risk metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
General disorders Nausea	7.1% 1/14 • Number of events 2
Gastrointestinal disorders Reflux	7.1% 1/14 • Number of events 1

Other adverse events

Measure	Metformin /Carbohydrate Restricted Diet n=14 participants at risk metformin and carbohydrate restricted diet added to platinum based chemotherapy regimen metformin: Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy carbohydrate restricted diet: addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
General disorders Fatigue	7.1% 1/14 • Number of events 6
Blood and lymphatic system disorders Anemia	7.1% 1/14 • Number of events 4
General disorders Nausea	7.1% 1/14 • Number of events 4
Blood and lymphatic system disorders Leukopenia	7.1% 1/14 • Number of events 3
Metabolism and nutrition disorders Hypoalbuminemia	7.1% 1/14 • Number of events 3

Additional Information

Dr. Anish Parikh

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-4705

Email: anish.parikh@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place