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Phase II Study to Investigate the Treatment of Patients With NSCLC Stage IIIB and IV Without the Option of Surgery With a Combination of Cisplatin, Docetaxel and Bevacizumab


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
NSCLC

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Trial Information

Phase II Study to Investigate the Treatment of Patients With NSCLC Stage IIIB and IV Without the Option of Surgery With a Combination of Cisplatin, Docetaxel and Bevacizumab


Inclusion Criteria:



- Histologically or cytologically documented inoperable, locally advanced, metastatic
or recurrent NSCLC other than squamous cell

- At least 1 measurable lesion according to RECIST criteria

- ECOG performance score 0 or 1

- Age between 18 and 70 years

Exclusion Criteria:

- Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a
predominant squamous component.

- History of haemoptysis

- Evidence of tumour invading major blood vessels on imaging.

- Previous neoadjuvant/adjuvant chemotherapy.

- Previous radiotherapy.

- Serious uncontrolled coagulation disorder or thrombo-embolic complications within 6
months prior to study start or history of serious bleeding complications.

- Major surgical procedures within 4 weeks prior to study entry.

- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior
to the first bevacizumab infusion.

- Non-healing wound, active peptic ulcer or bone fracture.

- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess
within 6 months of enrolment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response Rate

Outcome Description:

The primary objective of this proof-of-concept study is to determine the objective response rate in patients with unresectable, stage IIIB and IV non-small cell lung carcinoma treated with the combination cisplatin, docetaxel and bevacizumab. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials.

Outcome Time Frame:

4 years

Safety Issue:

Yes

Authority:

Austria: Federal Office for Safety in Health Care

Study ID:

AGMT_NSCLC 1

NCT ID:

NCT01368848

Start Date:

April 2010

Completion Date:

December 2014

Related Keywords:

  • NSCLC
  • AGMT
  • NSCLC
  • non-small cell lung cancer
  • bevacizumab
  • Avastin
  • Cisplatin
  • Docetaxel
  • Taxotere
  • Bevacizumab
  • Inoperable
  • stages IIIB and IV
  • Carcinoma, Non-Small-Cell Lung

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