A Study of MM-121 Combination Therapy in Patients With Advanced Non-Small Cell Lung Cancer

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: MM-121; Drug: Erlotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00994123

MM-121-01-101

Details and patient eligibility

About

A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Full description

Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with locally advanced or metastatic non-small cell lung cancer.
• Patients must be >/= 18 years of age.
• Patients must have adequate Performance Status (PS) as measured by ECOG and adequate end organ function.

Exclusion criteria

• Patients with a recent history (within 5 years) of another malignancy.
• Patients who are pregnant or nursing.
• Patients with clinically significant heart failure.
• Patients with clinically significant eye or gastrointestinal abnormalities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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162 participants in 3 patient groups

Phase 1: Dose-Escalation

Experimental group

Description:

Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO)

Treatment:

Drug: Erlotinib

Drug: MM-121

Phase 2: Control

Active Comparator group

Description:

Erlotinib (daily)

Treatment:

Drug: Erlotinib

Phase 2: Treatment

Experimental group

Description:

MM-121 (QOW IV) and erlotinib (daily PO)

Treatment:

Drug: Erlotinib

Drug: MM-121