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Clinical Trials/NCT00536640
NCT00536640
Completed
Phase 2

Inoperable Non-Squamous NSCLC Stage III/IV: A Randomised Phase II Study With Bevacizumab Plus Erlotinib Or Gemcitabin/Cisplatin Plus Bevacizumab

Aktion Bronchialkarzinom e.V.37 sites in 1 country224 target enrollmentNovember 2007
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ConditionsCarcinoma, Non-Small-Cell Lung
InterventionsErlotinibBevacizumabGemcitabineCisplatin
DrugsErlotinibBevacizumabGemcitabineCisplatin

Overview

Phase
Phase 2
Intervention
Erlotinib
Conditions
Carcinoma, Non-Small-Cell Lung
Sponsor
Aktion Bronchialkarzinom e.V.
Enrollment
224
Locations
37
Primary Endpoint
The main efficacy parameter is the progression free survival.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

This study wants to determine the activity of a non chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non Small Lung Cancer.

Detailed Description

Prospective, randomized multi-center, open label phase II study to determine the activity of a non-chemotherapy first line biological treatment with Erlotinib/Bevacizumab or Gemcitabine-Cisplatin/Bevacizumab in patients with the diagnosis of non-squamous advanced Non-Small-Lung-Cancer. * Duration of treatment/patient: up to 1,5 years * Follow Up: ≈ 6 month * Planned number of patients: 220 treated patients (110 patients/arm)

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
May 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aktion Bronchialkarzinom e.V.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Histological confirmed Non-Small Cell Lung Cancer that can not be treated within a defined radiological field
  • •Tumor stage IIIB (pleural effusion or pericardial effusion included) or IV
  • •The following histological tumor types are eligible:
  • •Adenocarcinoma (including adenocarcinomas with bronchioloalveolar differentiation)
  • •Large Cell Carcinoma (including large cell carcinomas with neuroendocrine differentiation)
  • •Mixed Cell Carcinoma without small cell fraction and without predominant squamous cell fraction (\< 50%)
  • •undifferentiated non-small-cell-carcinoma
  • •No previous chemotherapy within the last five years
  • •At least 4 weeks since last major surgery
  • •Age ≥ 18 years

Exclusion Criteria

  • •Histologic confirmed squamous cell carcinoma
  • •Pregnancy or lactation period
  • •Tumor extension treatable with radiotherapy
  • •Current clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan
  • •Evidence of tumor invading or abutting major blood vessels
  • •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of a CIS of the cervix or non-melanomatous skin cancer. Patients curatively treated and free of disease for at least 5 years will be discussed with the Principal Investigator (LKP) before inclusion
  • •Any previous chemotherapy within the last five years
  • •Any radiotherapy with exception of the following situations:
  • •concomitant small field radiotherapy in the case of solitary bone metastases or other solitary metastases
  • •in case of large field radiotherapy or multi-radiation fields due to multiple bone metastases or other metastases. The application of study medication then must be delayed at least for 24 h (after last radiotherapy)

Arms & Interventions

Arm A (Erlotinib, Bevacizumab)

Intervention: Erlotinib

Arm A (Erlotinib, Bevacizumab)

Intervention: Bevacizumab

Arm B (Gemcitabine, Cisplatin, Bevacizumab)

Intervention: Bevacizumab

Arm B (Gemcitabine, Cisplatin, Bevacizumab)

Intervention: Gemcitabine

Arm B (Gemcitabine, Cisplatin, Bevacizumab)

Intervention: Cisplatin

Outcomes

Primary Outcomes

The main efficacy parameter is the progression free survival.

Time Frame: Recruitment 1 year, Follow up 2 years

Secondary Outcomes

  • Overall survival(Recruitment 1 year, Follow up 2 years)
  • Quality of life(Screening, prior to next treatment cycle, treatment day 126, end of therapy)
  • Response rate(Screening, prior to treatment cycle 3, prior to treatment clycle 5, treatment day 126, every 6 weeks after treatment day 126, end of therapy)
  • Molecular investigations(Screening, prior to treatment cycle 3)

Study Sites (37)

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