Clinical Trials Logo
  1. Home
  2. Squamous Cell Lung Cancer
  3. NCT01082549

Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC) — ECLIPSE  

Squamous Cell Lung Cancer Clinical Trial

Official title:
Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

Clinical Trial Summary

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01082549
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 3
Start date March 2010
Completion date April 2013
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Withdrawn NCT03346304 - Photodynamic Therapy for the Prevention of Lung Cancer Phase 2/Phase 3
Recruiting NCT02288026 - Comparison of Different Types of Surgery in Treating Patients With Early-stage Non-small Cell Lung Cancer N/A
Terminated NCT01491633 - Dasatinib in Advanced Squamous Cell Lung Cancer Phase 2
Completed NCT00087412 - S0341: Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer Phase 2
Completed NCT00049543 - Gefitinib in Treating Patients With Stage IB, II, or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery Phase 3
Active, not recruiting NCT04357873 - Efficacy of Immunotherapy Plus a Drug in Patients With Progressive Advanced Mucosal Cancer of Different Locations Phase 2
Recruiting NCT02787473 - A Study of Pemetrexed Plus Cisplatin With Concurrent Radiation Therapy Followed by Docetaxel Consolidation in Patients With Inoperable Squamous Cell Lung Cancer Phase 2
Completed NCT00387374 - Radiation Therapy, Bevacizumab, Paclitaxel, and Carboplatin in Treating Patients With Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer at High Risk for Hemoptysis Caused by Bevacizumab Phase 2
Completed NCT00002852 - Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer Phase 3
Recruiting NCT05550961 - APOLLO 11, Consortium of Italian Centers Involved in Treatment of Patients With Lung Cancer Treated With Innovative Therapies: Real World Data and Translational Reaserch
Active, not recruiting NCT05292859 - Long-Term Follow-up Study of Subjects Treated With Autologous T Cells Using the Sleeping Beauty System to Express TCRs
Recruiting NCT05607108 - A Study of ZEN003694 in People With Squamous Cell Lung Cancer Phase 2
Terminated NCT03574818 - Necitumumab in the Neoadjuvant Setting With Gemcitabine in Surgically Resectable - 14X-US-I001 Phase 2
Suspended NCT00909558 - Safety and Effectiveness Study of Autologous Natural Killer and Natural Killer T Cells on Cancer Phase 1
Completed NCT00040794 - Combination Chemotherapy, Radiation Therapy, and Gefitinib in Treating Patients With Stage III Non-Small Cell Lung Cancer Phase 2
Terminated NCT00042835 - Erlotinib and Radiation Therapy Plus Combination Chemotherapy in Treating Patients With Inoperable Stage III Non-Small Cell Lung Cancer Phase 1
Terminated NCT03827850 - FGFR Inhibitor in FGFR Dysregulated Cancer Phase 2
Active, not recruiting NCT01345851 - Image-Guided Hypofractionated Radiation Therapy With Stereotactic Body Radiation Therapy Boost and Combination Chemotherapy in Treating Patients With Stage II-III Non-Small Cell Lung Cancer That Cannot Be Removed By Surgery N/A
Withdrawn NCT02059967 - Phase I IGART Study Using Active Breathing Control and Simultaneous Boost for Patients With NSCLC Phase 1