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

A Randomized, Multicenter, Open-Label Phase 3 Study of Pemetrexed-Cisplatin Chemotherapy Plus IMC-11F8 Versus Pemetrexed-Cisplatin Chemotherapy Alone in the First-Line Treatment of Patients With Nonsquamous Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Acronym INSPIRE

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/001182
Enrollment
947
Registered
2010-10-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Advanced nonsquamous non small cell lung cancer

Interventions

Intervention1: Necitumumab IMC-11F8 (16mg/ml), intravenous infusion:: Patients will receive IMC-11F8 (2 x 800 mg per three week cycle) until there is documentation of Progression of Disease, unaccepta
per cycle for 6 three-week cycles Intervention3: Cisplatin ((0.5mg/ml):: intravenous infusion 75 mg/m&sup2
per cycle for 6 three-week cycles Control Intervention1: Nil: Nil

Sponsors

ImClone LLC ImClone
Lead Sponsor
PAREXEL INTERNATIONAL CLINICAL RESARCH PVT LTD
Collaborator

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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. Timepoint: Nil—

Secondary

MeasureTime frame
To evaluate progression-free survival (PFS) in each arm.Timepoint: Nil—

Countries

Australia, Austria, Belgium, Brazil, Canada, Croatia, France, Germany, Greece, Hungary, India, Italy, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, United Kingdom, United States of America

Contacts

Public ContactDenzil Benjamin
Nilam.Gawande@ppdi.com02242486932

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026