A Randomised Phase 2 Trial of Pemetrexed and Gefitinib Versus Gefitinib as First Line Treatment for Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer With Activating Epidermal Growth Factor Receptor Mutations

Phase 2

• Conditions: Carcinoma, Non Small Cell Lung

• Registration Number: JPRN-jRCT1080221763
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically or cytologically confirmed advanced (Stage IV) or recurrent non-squamous NSCLC.
-Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
-The participant's primary NSCLC tumor has an activating Epidermal Growth Factor Receptor (EGFR) mutation, as determined by any validated method.
-The participant has measurable disease at the time of study entry.
-The participant has not had any prior systemic chemotherapy, immunotherapy, or biological therapy (for example, targeted therapy, such as erlotinib or gefitinib) for Stage IV or recurrent non-squamous NSCLC.
-The participant has adequate organ function(hematopoietic function, liver function, renal function).
-The participant is able to take folic acid, vitamin B12, and dexamethasone, according to the protocol's requirements.
-Prior radiation therapy is allowed to <25% of the bone marrow.

Exclusion Criteria

-The participant is receiving concurrent treatment with any other anticancer therapy.
-The participant has untreated central nervous system (CNS) metastases.
-The participant has a serious illness or medical condition that would compromise their safety or impair their ability to comply with the protocol's requirements.
-Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose equal to or less than 1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed.
-Concomitant use of cytochrome P450 (CYP)3A4 inducers or CYP3A4 inhibitors.
-Any known significant ophthalmologic abnormalities of the surface of the eye. The use of contact lenses is not recommended during the study.
-The participant has previously received treatment with gefitinib, erlotinib or pemetrexed.
-Any evidence of clinically active interstitial lung disease.
-The participant is pregnant or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified