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Lung CancerPhase 2ALMERANCT02115464

Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy

A Phase 2 study testing Metformin plus Chemo-radiotherapy and Chemo-radiotherapy in people with Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 7 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 with or without consolidation versus the same treatment plus concurrent Metformin continuing for 12 months. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lung Cancer
What is being tested?
Metformin plus Chemo-radiotherapy and Chemo-radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
7 sitesCanada
Study dates
17 Dec 2014to 21 Apr 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >/=18 to </= 80 years of age.
  • 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.
  • Non-metastatic disease staged by: CT-chest and upper abdomen, brain MRI or contrast-enhanced CT within 12 weeks and physical examination and whole body FDG-PET/CT scan within 8 weeks prior to study randomization.

Who cannot join

  • Eastern Cooperative Oncology Group (ECOG) performance status >2.
  • More than 10% weight loss in the past 3 months.
  • Diabetic patient or anyone currently taking Metformin, insulin or other anti-hyperglycemic therapy.
  • 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.
  • Complete Blood Count (CBC) and biochemical renal and liver function profiles that do not permit chemotherapy treatment (as per institutional standard of care).
  • Fasting blood sugar levels of >/= 7.0 mmol per litre (within the last 12 weeks).
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  • Prior systemic chemotherapy for lung cancer.
  • Prior radiotherapy that would overlap with the planned treatment area.
  • 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).
  • Known Acquired Immune Deficiency Syndrome (AIDS).
  • 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
  • Known hypersensitivity or allergy to Metformin.
  • Known pregnancy or lactating female patient.
  • Geographic inaccessibility for follow-up.
  • Inability to provide informed consent.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Canada7 sites

  • Cross Cancer Institute

    Edmonton, Alberta

  • Juravinski Cancer Centre

    Hamilton, Ontario

  • Cancer Centre of Southeastern Ontario at Kingston General Hospital

    Kingston, Ontario

  • Grand River Regional Cancer Centre

    Kitchener, Ontario

  • Montreal General Hospital - McGill

    Montreal, Quebec

  • Walker Family Cancer Centre - Niagara Health System

    St. Catharines, Ontario

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

About this study

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

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 with or without consolidation 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.

Read the 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) with or without consolidation (standard arm) vs the same CRT with or without consolidation 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 with or without consolidation 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.

Conditions
Lung Cancer
Being tested
Metformin plus Chemo-radiotherapy, Chemo-radiotherapy
Keywords
Metformin, Non-small cell lung cancer, Locally advanced, Chemo-radiotherapy, Lung cancer treatment
Medical subject headings
Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Metformin plus Chemo-radiotherapyDrug

    Also called Metformin Hydrochloride

    Metformin 2000 mg a day for 12 months plus cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.

  • Chemo-radiotherapyRadiation

    Cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.

Study groups in NCT02115464
Study groupRoleWhat they receive
Metformin plus Chemo-radiotherapyExperimentalMetformin 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 or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.
Receives: Drug: Metformin plus Chemo-radiotherapy
Chemo-radiotherapyActive comparatorConcurrent cisplatin based chemotherapy with or without consolidation and radiotherapy of 60-63 Gy for 6 weeks.
Receives: Radiation: Chemo-radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Progression free survival illustrates loco-regional disease control and freedom from distant metastasis

    Measured: 12 months

Secondary outcomes (4)

  1. Overall survival

    Overall survival will be defined from the date of randomization until the date of death due to any cause.

    Measured: 18-24 months

  2. Time to loco-regional progression

    Time to loco-regional progression is defined from the date of randomization until the date of confirmed loco-regional progression

    Measured: 18-24 months

  3. Distant progression-free survival

    Distant progression-free survival is defined from the date of randomization until the date of distant progression, or death due to any cause.

    Measured: 18-24 months

  4. Toxicities

    The adverse event reporting period begins from the time of randomization and ends 30 days after the last treatment (concurrent chemo-radiotherapy plus or minus Metformin). Only adverse events assessed as Grade 3 or higher will be documented.

    Measured: 12 months plus 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Apr 2014 (estimated)
  2. Study start17 Dec 2014
  3. Primary completion9 Mar 2020
  4. Study completion21 Apr 2020

Why it stopped: The accrual rate was not high enough to reach the target sample size.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02115464
Sponsor's protocol ID
OCOG-2014-ALMERA
Acronym
ALMERA
Status last verified
Apr 2020
First submitted
14 Apr 2014
Last updated
22 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tsakiridis T, Pond GR, Wright J, Ellis PM, Ahmed N, Abdulkarim B, Roa W, Robinson A, Swaminath A, Okawara G, Wierzbicki M, Valdes M, Levine M. Metformin in Combination With Chemoradiotherapy in Locally Advanced Non-Small Cell Lung Cancer: The OCOG-ALMERA Randomized Clinical Trial. JAMA Oncol. 2021 Sep 1;7(9):1333-1341. doi: 10.1001/jamaoncol.2021.2328.

    PubMed 34323924

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin plus Chemo-radiotherapy and Chemo-radiotherapy in people with Lung Cancer, run by Ontario Clinical Oncology Group (OCOG) at 7 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The accrual rate was not high enough to reach the target sample size.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02115464, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.

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