LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

Boehringer Ingelheim

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: docetaxel; Drug: nintedanib; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02231164

1199.128

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients of at least 18 years of age
• Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.

Exclusion criteria

• More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.
• Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation
• Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time
• Prior monotherapy with an EGFR inhibitor except as maintenance therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups, including a placebo group

Docetaxel and placebo

Placebo Comparator group

Description:

patients to receive backbone chemotherapy and placebo

Treatment:

Drug: placebo

Drug: docetaxel

Drug: docetaxel

Docetaxel and Nintedanib

Experimental group

Description:

patients to receive backbone chemotherapy and nintedanib

Treatment:

Drug: nintedanib

Drug: docetaxel

Drug: docetaxel