A Phase I/II Study of Continuous Oral Treatment With BIBF 1120 Added to Standard Gemcitabine/Cisplatin Therapy in First Line NSCLC Patients With Squamous Cell Histology.

NCT01346540 | Completed Phase 1 Results

• 2 other identifiers: 1199.822010-019707-32
• Study Type: interventional
• Target: 16
• Locations: 4 countries
• Sites: 7

Brief Summary

The LUME-Lung3 study is in 2 parts: Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin. Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2 previous courses of the chemotherapy

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicities (DLTs) During First Cycle for the Determination of the Maximum Tolerated Dose (MTD)

  The following drug-related adverse events (AEs) qualified as a DLT: Non-hematological toxicity - Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥3 events excluding transient electrolyte abnormality, hyperuricemia and isolated elevation of gamma-glutamyl trans-peptidase. Gastrointestinal AEs (nausea, vomiting, diarrhoea, abdominal pain) or hypertension of CTCAE Grade ≥3 despite optimal supportive care/intervention. Alanine aminotransferase and or Aspartate aminotransferase elevation of CTCAE Grade ≥3. Haematological toxicity - Uncomplicated CTCAE Grade 4 neutropenia (that was not associated with fever of ≥38.5° Celsius) for \>7 days (except during Cycle 1). CTCAE Grade 4 febrile neutropenia associated with fever ≥38.5º Celsius. A decrease in platelet levels to CTCAE Grade 4 or CTCAE Grade 3 associated with bleeding or requiring transfusion. The inability to resume nintedanib dosing within 14 days of stopping due to a drug-related AE was also considered a DLT.

  Up to 21 days from first drug administration

• Maximum Tolerated Dose (MTD) of Nintedanib Added to Cisplatin/Gemcitabine Based on the Occurrence of DLTs During Treatment Cycle 1.

  The MTD was defined as the dose of nintedanib administered with gemcitabine/cisplatin at which no more than 1 of 6 patients experienced DLT (or one dose tier below that dose at which 2 or more of 6 patients experienced DLT) during the first 21-day treatment cycle. Any DLTs experienced after the start of the second treatment period were considered separately.

  Up to 21 days from first drug administration

Secondary Outcomes (1)

• Incidence of Adverse Events (AEs) According to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.00

  From the first drug administration until 28 days after last study drug administration, up to 804 days

Study Arms (2)

BIBF 1120

EXPERIMENTAL

VEGF inhibitor

Drug: BIBF 1120

Placebo

PLACEBO COMPARATOR

BIBF 1120 placebo

Drug: Placebo

Interventions

BIBF 1120 DRUG

VEGF inhibitor

BIBF 1120

Placebo DRUG

BIBF 1120 placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Run-in Phase I
• Histologically or cytologically confirmed diagnosis of stage IIIB/IV or recurrent Non Small Cell Lung Cancer (NSCLC) with squamous cell histology.
• Measurable disease according to Response Evaluation Criteria in Solid Tumours ( RECIST 1.1).
• Patient Eastern Cooperative Oncology Group (ECOG) score of 0-1.
• Male or female patients age = 18 years.
• Life expectancy of at least three (3) months.
• Written informed consent in accordance with International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) guidelines.
• Phase II - in addition to the above criteria:
• Radiologically-confirmed at least stable disease after 2 prior cycles of cisplatin / gemcitabine chemotherapy.

You may not qualify if:

• Prior therapy for advanced or metastatic or recurrent Non Small Cell Lung Cancer (NSCLC). One prior adjuvant, neoadjuvant or adjuvant + neoadjuvant treatment is allowed if at least 12 months have elapsed between the end of the treatment and randomization
• Prior treatment with other Vascular Endothelial Growth Factor Receptor (VEGFR) inhibitors (other than bevacizumab)
• Any contraindications for treatment with gemcitabine and/or cisplatin.
• Use of any investigational drug within 4 weeks of entering the 1199.82 study.
• History of major thrombotic or clinically relevant bleeding event in the past 6 months.
• Significant cardiovascular diseases (i.e. hypertension not controlled by medication.
• Surgery within 4 weeks (except tumour biopsy) prior randomisation and incomplete wound healing.
• Active brain metastases
• Radiotherapy (except extremities) within 3 months prior to baseline imaging and radiotherapy for brain metastasis \< 4 weeks prior baseline imaging.
• Any other current malignancy or malignancy diagnosed within the past five (5) years.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (7)

1199.82.39004 Boehringer Ingelheim Investigational Site

Milan, Italy

Location

1199.82.3102 Boehringer Ingelheim Investigational Site

Maastricht, Netherlands

Location

1199.82.3401 Boehringer Ingelheim Investigational Site

Barcelona, Spain

Location

1199.82.3406 Boehringer Ingelheim Investigational Site

Madrid, Spain

Location

1199.82.3410 Boehringer Ingelheim Investigational Site

Málaga, Spain

Location

1199.82.4401 Boehringer Ingelheim Investigational Site

London, United Kingdom

Location

1199.82.4402 Boehringer Ingelheim Investigational Site

Manchester, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

nintedanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

This trial was prematurely discontinued (Phase II was not conducted) following Sponsor's decision not to continue the trial in this indication.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2011
• First Posted: May 3, 2011
• Study Start: April 14, 2011
• Primary Completion: April 25, 2013
• Study Completion: January 17, 2017
• Last Updated: February 12, 2025
• Results First Posted: September 10, 2018

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); NL (1); ES (3); GB (2)