Study of Pemetrexed Versus Pemetrexed Plus Erlotinib as Treatment of Nonsquamous Non-Small Cell Lung Cancer (NSCLC)

Lilly

Status and phase: Completed; Phase 2

Conditions: Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.

Treatments: Drug: Pemetrexed; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447057

10721

H3E-MC-S102 (Other Identifier)

Details and patient eligibility

About

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival [PFS], disease control rate, best response rate, time to treatment failure [TTTF], overall survival [OS] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Enrollment: 204 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological diagnosis of locally advanced or metastatic NSCLC that is of nonsquamous histology and not amenable to curative therapy.
• Failure of previous treatment with one prior platinum-based chemotherapy regimen.
• Good performance status.
• Adequate bone marrow reserve, renal and hepatic functions.

Exclusion criteria

• Serious concomitant systemic disease.
• Inability to take oral medication.
• Inability or unwillingness to take vitamin supplementation and corticosteroids.
• Pregnancy / Breast-feeding.
• Treatment with certain medicines that prevent blood from clotting.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 4 patient groups

Pemetrexed (Nonsquamous)

Experimental group

Description:

Group of participants with non-small cell lung cancer (NSCLC) of nonsquamous histology who were assigned to Pemetrexed arm

Treatment:

Drug: Pemetrexed

Drug: Pemetrexed

Pemetrexed + Erlotinib (Nonsquamous)

Experimental group

Description:

Group of participants with NSCLC of nonsquamous histology who were assigned to Pemetrexed + Erlotinib arm

Treatment:

Drug: Pemetrexed

Drug: Erlotinib

Drug: Erlotinib

Drug: Pemetrexed

Pemetrexed (Squamous)

Experimental group

Description:

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed arm

Treatment:

Drug: Pemetrexed

Drug: Pemetrexed

Pemetrexed + Erlotinib (Squamous)

Experimental group

Description:

Group of participants with NSCLC of squamous histology who were assigned to Pemetrexed + Erlotinib arm

Treatment:

Drug: Pemetrexed

Drug: Erlotinib

Drug: Erlotinib

Drug: Pemetrexed