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A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Randomised Open-label Phase II Trial of BI 6727 Monotherapy and BI 6727 in Combination With Standard Dose Pemetrexed Compared to Pemetrexed Monotherapy in Second Line Non-small Cell Lung Cancer

Inclusion Criteria

Inclusion criteria:

1. Pathologic or cytologic confirmed diagnosis of NSCLC

2. Recurrent, advanced or metastatic NSCLC that has progressed following one prior
platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant
chemotherapy if completed more than 12 months prior to platinum based therapy)

3. Patients who are eligible for pemetrexed as second line chemotherapy

4. Measurable disease by one or more techniques (CT, MRI) according to RECIST

5. Patients aged 18 years or older

6. Life expectancy of at least three (3) months

7. Eastern Cooperative Oncology Group (ECOG) performance Score 0-2

8. Written informed consent that is consistent with ICH-GCP guidelines and local

Exclusion criteria:

1. Treatment with an investigational drug in another clinical study within the past 28
days prior to the start of therapy or concomitantly with this study

2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the
past 28 days prior to Treatment Day 1 of Cycle 1 of this trial

3. Any persisting toxicities which are deemed to be clinically significant from the
previous therapy

4. Patients who have received more than one prior chemotherapy regimen for advanced
disease (not including prior adjuvant therapy). Patients may have received prior
epidermal growth factor receptor tyrosine kinase inhibitors.

5. Patients who are unwilling or unable to take folic acid and vitamin B12

6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent
steroids). Patients who have received prior whole brain irradiation and whose brain
metastases are stable according to the criteria above will not be excluded.

7. Other active malignancy diagnosed within the past 3 years (other than non
melanomatous skin cancer and cervical intraepithelial neoplasia)

8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness or social situation that would limit compliance
with trial requirement or which are considered relevant for the evaluation of the
efficacy or safety of the trial drug

9. Patients unable or unwilling to interrupt concomitant administration of NSAIDS 5 days
prior to, the day of and 2 days after the administration of pemetrexed, with the
exception of lose dose aspirin 81mg daily

10. Patients who have received prior therapy with pemetrexed

11. Absolute neutrophil count (ANC) less than 1,500/mm3

12. Platelet count less than 100,000/mm3

13. Hemoglobin <90g/L

14. Total bilirubin >26┬Ámol/L

15. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than
2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is

16. Serum creatinine level >133┬Ámol/L and/or creatinine clearance (measured or
calculated) <45 ml/min

17. Clinically relevant QTc prolongation

18. Women and men who are sexually active and unwilling to use a medically acceptable
method of contraception

19. Pregnancy or breast feeding

20. Known or suspected active alcohol or drug abuse

21. Patients unable to comply with the protocol

22. Any known hypersensitivity to the trial drugs or their excipients

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival time (PFS) from the date of randomization to the earlier date of disease progression or death.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Boehringer Ingelheim

Investigator Role:

Study Chair

Investigator Affiliation:

Boehringer Ingelheim Pharmaceuticals



Study ID:




Start Date:

March 2009

Completion Date:

September 2012

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung