NGR-hTNF in Combination With Standard Chemotherapy to Treat Patients With Advanced Non-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT00994097
- Lead Sponsor
- AGC Biologics S.p.A.
- Brief Summary
The main objective of this study is to demonstrate superiority in progression-free survival (PFS) when NGR-hTNF is added to standard chemotherapy regimen (cisplatin/gemcitabine or cisplatin/pemetrexed) in locally advanced (stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (stage IV) or recurrent non-small cell lung cancer (NSCLC).
- Detailed Description
Eligible patients will be randomly assigned to a standard chemotherapy regimen plus low-dose (0.8 mcg/m\^2) NGR-hTNF or standard chemotherapy alone, through a centralized randomization process using the following stratification factors: performance status (0 vs 1) and histology (squamous vs non-squamous). In both arms the choice between the two chemotherapy regimens will be based on the histologic subtype: in patients with squamous histology (including also generic diagnosis of NSCLC without further subtype classification) is recommended cisplatin/gemcitabine regimen, in patients with nonsquamous histology (including adenocarcinoma and large-cell carcinoma) is recommended cisplatin/pemetrexed regimen.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 121
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed Gemcitabine NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed NGR-hTNF NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed Cisplatin NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology A: NGR-hTNF + cisplatin/gemcitabine or cisplatin/pemetrexed Pemetrexed NGR-hTNF with cisplatin/gemcitabine regimen in patients with squamous histology or with cisplatin/pemetrexed regimen in patients with nonsquamous histology B: cisplatin/gemcitabine or cisplatin/pemetrexed Gemcitabine Cisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology B: cisplatin/gemcitabine or cisplatin/pemetrexed Cisplatin Cisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology B: cisplatin/gemcitabine or cisplatin/pemetrexed Pemetrexed Cisplatin/gemcitabine regimen is administered in patients with squamous histology and cisplatin/pemetrexed regimen is administered in patients with nonsquamous histology
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD PFS evaluated according to Response evaluation criteria in solid tumors (RECIST)
- Secondary Outcome Measures
Name Time Method Objective response rate Every 6 weeks during study treatment and every 6 weeks during the follow-up before PD Antitumor activity defined as response rate evaluated according to Response evaluation criteria in solid tumors (RECIST)
Duration of response (DR) from the time of first recorded evidence of complete response or partial response until the progressive disease objectively documented defined as the time that measurement criteria are met for complete response or partial response (whichever status is recorded first) until the progressive disease is objectively documented.
Safety according to NCI-CTCAE criteria (version 3) from the date of randomization until 28 days after last treatment To evaluate safety profile related to NGR-hTNF in combination with standard chemotherapy
Overall survival (OS) from the randomization until to the date of patient death or discontinuation from the study Defined as the time from the date of randomization until the date of death due to any cause or the last date the patient was known to be alive
Trial Locations
- Locations (4)
Fondazione San Raffaele del Monte Tabor
🇮🇹Milan, Italy
Istituto Europeo Oncologico
🇮🇹Milan, Italy
Istituto Nazionale per la ricerca sul cancro
🇮🇹Genoa, Italy
Istituto Nazionale dei Tumori
🇮🇹Milan, Italy