Clinical trial · Interventional
Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy
A Phase II Study to Investigate a Combination of Metformin With Chemo-Radiotherapy in Patients With Locally Advanced Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The accrual rate was not high enough to reach the target sample size.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemo-radiotherapy | Radiation | — | UNRESOLVED |
| Metformin plus Chemo-radiotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Metformin plus Chemo-radiotherapy
- description
- 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 or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.
- interventionNames
- Drug: Metformin plus Chemo-radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- Chemo-radiotherapy
- description
- Concurrent cisplatin based chemotherapy with or without consolidation and radiotherapy of 60-63 Gy for 6 weeks.
- interventionNames
- Radiation: Chemo-radiotherapy
Primary outcomes (1)
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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: 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.
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 (within the last 12 weeks).
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.References
Publications (1)
- DERIVEDTsakiridis 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. PMID 34323924