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History of Changes for Study: NCT02115464
Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy (ALMERA)
Latest version (submitted April 21, 2020) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 14, 2014 None (earliest Version on record)
2 August 25, 2014 Study Status, Contacts/Locations and Oversight
3 September 24, 2014 Recruitment Status, Study Status and Contacts/Locations
4 October 6, 2014 Study Status and Contacts/Locations
5 December 8, 2014 Study Status and Contacts/Locations
6 February 3, 2015 Study Status and Contacts/Locations
7 June 12, 2015 Study Status
8 June 29, 2015 Contacts/Locations and Study Status
9 August 21, 2015 Study Status and Contacts/Locations
10 October 5, 2015 Study Status and Contacts/Locations
11 January 28, 2016 Study Status, Eligibility and Outcome Measures
12 June 6, 2016 Contacts/Locations and Study Status
13 December 12, 2016 Study Status
14 February 2, 2017 Study Status
15 March 6, 2017 Study Status, Arms and Interventions, Study Description and Eligibility
16 March 22, 2018 Study Status, Contacts/Locations and Oversight
17 November 2, 2018 Study Status and Contacts/Locations
18 March 8, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
19 April 24, 2019 Study Status
20 November 5, 2019 Study Status
21 December 2, 2019 Study Status
22 April 15, 2020 Study Status
23 April 21, 2020 Recruitment Status and Study Status
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Study NCT02115464
Submitted Date:  April 14, 2014 (v1)

Open or close this module Study Identification
Unique Protocol ID: OCOG-2014-ALMERA
Brief Title: Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy (ALMERA)
Official Title: A Phase II Study to Investigate a Combination of Metformin With Chemo-Radiotherapy in Patients With Locally Advanced Non-Small Cell Lung Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2014
Overall Status: Not yet recruiting
Study Start: June 2014
Primary Completion: December 2015 [Anticipated]
Study Completion: December 2017 [Anticipated]
First Submitted: April 14, 2014
First Submitted that
Met QC Criteria:
April 14, 2014
First Posted: April 16, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 14, 2014
Last Update Posted: April 16, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Ontario Clinical Oncology Group (OCOG)
Responsible Party: Sponsor
Collaborators: Canadian Institutes of Health Research (CIHR)
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: ALMERA is a randomized, phase II, open label study in patients with locally advanced non-small cell lung cancer (NSCLC) which will compare standard radiotherapy plus concurrent chemotherapy versus the same treatment plus concurrent Metformin continuing for 12 months. Metformin is a well tolerated and inexpensive drug that has the potential to improve cancer patient outcomes.
Detailed Description:

This is a randomized, phase II, open label study in patients with locally advanced NSCLC which will compare standard RT (60-63 Gy for 6 weeks) plus concurrent Cisplatin-based chemotherapy (CRT) (standard arm) vs the same CRT plus treatment with Metformin concurrent with CRT and continuing for a total of 12 months (experimental arm). Ninety-four eligible and consenting patients will be randomized to one of the two treatment arms. Patients randomized to the experimental arm will receive Metformin (2000 mg/day) for a period of 12 months. Patients will be continuously evaluated for toxicity, will be assessed weekly at clinic visits during concurrent CRT treatment and at follow up clinic visits at 3, 6, 9 and 12 months (from the date of randomization). Disease progression will be evaluated every 3 months for up to 12 months. All patients will be followed for up to 24 months (2 years) for survival.

The primary objective of this study is to determine the effect of Metformin on the proportion of patients free of disease progression at 12 months after initiation of drug treatment.

Open or close this module Conditions
Conditions: Lung Cancer
Keywords: Metformin
Non-small cell lung cancer
Locally advanced
Chemo-radiotherapy
Lung cancer treatment
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 94 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Metformin plus Chemo-radiotherapy
Metformin orally 500 mg twice daily for the first week, 1500 mg a day in week 2 and 2000 mg a day at week 3 and then for a period of 12 months. Cisplatin-based chemotherapy with standard radiotherapy of 60-63 Gy for 6 weeks.
Drug: Metformin plus Chemo-radiotherapy
Metformin 2000 mg a day for 12 months plus cisplatin-based chemotherapy with standard radiotherapy of 60-63 Gy for 6 weeks.
Other Names:
  • Metformin Hydrochloride
Active Comparator: Chemo-radiotherapy
Concurrent cisplatin based chemotherapy and radiotherapy of 60-63 Gy for 6 weeks.
Radiation: Chemo-radiotherapy
Cisplatin-based chemotherapy with standard radiotherapy of 60-63 Gy for 6 weeks.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Progression free survival
[ Time Frame: 12 months ]

Progression free survival illustrates loco-regional disease control and freedom from distant metastasis
Secondary Outcome Measures:
1. Overall survival
[ Time Frame: 18-24 months ]

Overall survival will be defined from the date of randomization until the date of death due to any cause.
2. Time to loco-regional progression
[ Time Frame: 18-24 months ]

Time to loco-regional progression is defined from the date of randomization until the date of confirmed loco-regional progression
3. Distant progression-free survival
[ Time Frame: 18-24 months ]

Distant progression-free survival is defined from the date of randomization until the date of distant progression, or death due to any cause.
4. Toxicities
[ Time Frame: 12 months plus 30 days ]

Adverse event reporting period begins from the time of the first dose of Metformin and ends 30 days after the last dose. Only adverse events assessed as Grade 3 or higher will be documented.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 80 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. Age >/=18 to </= 80 years of age.
  2. Unresected and pathologically (histologic) proven Stage 3a or Stage 3b NSCLC of adenocarcinoma, squamous cell, large cell or mixed histology, diagnosed within three months of study randomization.
  3. Non-metastatic disease staged by: physical examination, CT-chest and upper abdomen, brain MRI or contrast-enhanced CT and whole body Fluorodeoxyglucose (FDG)-PET/CT scan within two months of study randomization.

Exclusion Criteria:

  1. Eastern Cooperative Oncology Group (ECOG) performance status >2.
  2. More than 10% weight loss in the past 3 months.
  3. Diabetic patient or anyone currently taking Metformin, insulin or other anti-hyperglycemic therapy.
  4. Pulmonary Function Test (PFTs) (within the last 12 weeks) with Forced Expiratory Volume (FEV)1 < 1.2 litres per second or less than 50% of predicted.
  5. Complete Blood Count (CBC) and biochemical renal and liver function profiles that do not permit chemotherapy treatment (as per institutional standard of care).
  6. Fasting blood sugar levels of >/= 7.0 mmol per litre.
  7. Prior systemic chemotherapy for lung cancer.
  8. Prior radiotherapy that would overlap with the planned treatment area.
  9. Prior invasive malignancy within the past 3 years (except non-melanomatous skin cancer non-invasive carcinoma in-situ of the breast, oral cavity or cervix).
  10. Known Acquired Immune Deficiency Syndrome (AIDS).
  11. Patients with increased risk for lactic acidosis:
    • severe congestive heart failure (NYHA: class III or IV),
    • history of metabolic acidosis,
    • alcoholic intake of > 3 drinks daily,
    • severe liver disease,
    • renal failure
  12. Known hypersensitivity or allergy to Metformin.
  13. Known pregnancy or lactating female patient.
  14. Geographic inaccessibility for follow-up.
  15. Inability to provide informed consent.
Open or close this module Contacts/Locations
Central Contact Person: Kathryn Cline, BSc
Email: clinek@mcmaster.ca
Study Officials: Theodoros Tsakiridis, MD
Principal Investigator
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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