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Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Stage III Non-small Cell Lung Cancer

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Trial Information

Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)


Inclusion Criteria:



- non-squamous stage III non-small cell lung cancer

- measurable disease (RECIST 1.1)

- ECOG performance status 0-1

- normal organ and marrow function

Exclusion Criteria:

- prior chest radiation therapy

- history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma
in situ of the cervix) within the last five years.

- Prior therapy with known specific inhibitors of the EGFR.

- history of severe allergic reaction to prior therapy with monoclonal antibodies

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease-Control Rate

Outcome Time Frame:

16 weeks after inclusion

Safety Issue:

No

Principal Investigator

Jean Trédaniel, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

IFCT, GH Paris Saint-Joseph

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

IFCT-0803

NCT ID:

NCT01102231

Start Date:

March 2010

Completion Date:

December 2013

Related Keywords:

  • Stage III Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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