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LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
Phase 3 trial testing docetaxel in Carcinoma, Non-Small-Cell Lung in 12 participants. Terminated before completion.
| Lead sponsor | Boehringer Ingelheim |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 14 October 2014 |
| Primary completion | 24 December 2015 |
| Estimated completion | 24 December 2015 |
| Sites | 13 locations across Georgia, Thailand, United States |
Boehringer Ingelheim — full company profile →
18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease.
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 66.7 | |
| Nintedanib | 50.0 |
| Group | Value | 95% CI |
|---|---|---|
| Placebo | 33.3 | |
| Nintedanib | 50.0 |
Time frame: From first drug administration until 28 days after last drug administration, up to 7 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Placebo | Nintedanib |
|---|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Cardio-respiratory arrest | Cardiac disorders | — | — |
| Tachycardia | Cardiac disorders | — | — |
| Clostridium difficile infection | Infections and infestations | — | — |
| Pneumonia | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Hypoglycaemia | Metabolism and nutrition disorders | — | — |
| Lactic acidosis | Metabolism and nutrition disorders | — | — |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | — | — |
| Metastases to skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Orthostatic hypotension | Vascular disorders | — | — |
| Reaction | System | Placebo | Nintedanib |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Neuropathy peripheral | Nervous system disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Leukopenia | Blood and lymphatic system disorders | — | — |
| Visual impairment | Eye disorders | — | — |
| Oral pain | Gastrointestinal disorders | — | — |
| Pain | General disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Lacrimation increased | Eye disorders | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Dry mouth | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Dysphagia | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Frequent bowel movements | Gastrointestinal disorders | — | — |
| Glossodynia | Gastrointestinal disorders | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Chest pain | General disorders | — | — |
| Chills | General disorders | — | — |
| Facial pain | General disorders | — | — |
| Mucosal inflammation | General disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Polyp | General disorders | — | — |
| Pyrexia | General disorders | — | — |
| Allergy to arthropod sting | Immune system disorders | — | — |
Most-reported serious reactions: Malignant neoplasm progression, Febrile neutropenia, Atrial fibrillation, Cardio-respiratory arrest, Tachycardia, Clostridium difficile infection, Pneumonia, Sepsis.
Data from ClinicalTrials.gov NCT02231164 adverse events section.
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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