Non Squamous Non-Small Cell Lung Cancer treatment with the Inhibitor of Epidermal growth factor receptor

Phase 3

• Conditions: Advanced nonsquamous non small cell lung cancer

• Registration Number: CTRI/2010/091/001182
• Lead Sponsor: ImClone LLC ImClone

Brief Summary

This study is a randomized, multicenter, open-label phase 3 study comparing the first-line treatment of pemetrexed-cisplatin chemotherapy combined with IMC11F8 versus pemetrexed-cisplatin chemotherapy alone in 947 patients with advanced, nonsquamous (stage IIIb or IV) non-small cell lung cancer. Patients will be enrolled from 175 study centers in North America, South America, Europe, Australia, South Africa and India. The primary objective is to evaluate overall survival. Secondary objectives include progression free survival, objective response rate, time to treatment failure, safety profile, pharmacokinetics and immunogenicity of IMC-11F8, health status, and efficacy parameters as a function of EGFR gene copy number and mutation status. Tentative enrollment start in India will be in31 AUG 2010 after DCGI approval has been obtained. The tartgeted number of patients in India is 45 patients at 6 sites.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-11
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: Not Applicable
• Sex: All
• Target Recruitment: 947

Inclusion Criteria

• Histologically- or cytologically-confirmed nonsquamous (adenocarcinoma/large cell or other) NSCLC ?
• Advanced (Stage IIIB or Stage IV) disease at the time of study entry ?
• Measurable or nonmeasurable (ie, evaluable) disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0 ?
• Tumor tissue available for analysis of EGFR gene copy number and EGFR mutation status (minimum of eight slides, formalin-fixed, paraffin-embedded tissue).

Exclusion Criteria

• Squamous cell NSCLC.
• Prior therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, VEGF, or VEGFR ?
• Previous chemotherapy for advanced NSCLC (patients who have received adjuvant chemotherapy ≥ 1 year prior to randomization are eligible) ?
• Major surgery or any investigational therapy in the 4 weeks prior to randomization ?
• Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed) ?
• Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the overall survival (OS) in patients with nonsquamous Stage IIIb or IV NSCLC treated with IMC-11F8 plus pemetrexed-cisplatin chemotherapy (Arm A) versus pemetrexed-cisplatin chemotherapy alone (Arm B) in the first-line metastatic setting.	Nil

Secondary Outcome Measures

Name	Time	Method
To evaluate progression-free survival (PFS) in each arm.	Nil

Trial Locations

Locations (6)

Haemato-Oncology Clinic, Vedanta; 🇮🇳 Ahmadabad, GUJARAT, India

Indraprastha Apollo Hospital; 🇮🇳 Delhi, DELHI, India

Jaslok Hospital and Research Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

MNJ Institute of Oncology and Regional Cancer Center; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Shatabdi Superspeciality Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

SK Soni Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Haemato-Oncology Clinic, Vedanta

🇮🇳Ahmadabad, GUJARAT, India

Dr. Chirag Desai

Principal investigator

chiragdesai.oncology@gmail.com