Phase I Imaging Study Evaluating Dalotuzumab (MK0646) in Combination With Erlotinib for Patients With Non-Small Cell Lung Cancer (MK-0646-008)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Carcinoma, Non-small Cell Lung

Treatments: Drug: Comparator: erlotinib monotherapy; Drug: Comparator: erlotinib + dalotuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729742

0646-008

2008_518

CTRI/2009/091/000139 (Registry Identifier)

Details and patient eligibility

About

This study will use imaging to look at tumor response to erlotinib (Part I) and the combination of erlotinib and dalotuzumab (Part II).

Enrollment: 49 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has locally advanced or metastatic stage IIIB/IV Non-small cell lung cancer
• Patient has measurable disease
• Patient has accessible tumor and consents to undergo a tumor biopsy [Part II only]
• Patient is 18 years of age or older
• Patient has a performance status of 0-2 on ECOG scale
• Women of childbearing potential have a negative pregnancy test
• Patients in Part I must: 1. be a female non-smoker with non-squamous histology who has had one or two prior systemic chemotherapies or 2. have documented EGFR mutation or EGFR gene amplification, regardless of demographic or clinical characteristics, who have had no more than two prior systemic chemotherapies.
• Patients in Part II must have had one or two chemotherapy regimens for recurrent or metastatic disease

Exclusion criteria

• Patient has had chemotherapy within 2 weeks or biological therapy (e.g. bevacizumab) within 4 weeks
• Patient has not recovered from adverse events from previous therapy within 4 weeks
• Patient has received EGFR-TKI inhibitor/anti-EGFR mAb therapy
• Patient has received IGF1R-TKI inhibitor/anti-IGF1R mAB therapy
• Patient has untreated brain metastases
• Patient has had radiotherapy to a field that affects the chest or abdomen, or thoracic surgery within 3 months prior to entering the study
• Patient is taking part in another clinical study
• Patient abuses drugs or alcohol
• Patient is pregnant or breastfeeding
• Subject is HIV positive
• Patient has active hepatitis
• Patient is using growth hormone or growth hormone inhibitors
• Patient has poorly controlled diabetes mellitus

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

49 participants in 2 patient groups

Part 1

Experimental group

Description:

erlotinib

Treatment:

Drug: Comparator: erlotinib monotherapy

Part 2

Experimental group

Description:

erlotinib + dalotuzumab

Treatment:

Drug: Comparator: erlotinib + dalotuzumab