Non Small Cell Lung Cancer Clinical Trial
Official title:
Phase II, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy of AZD6244 in Combination With Docetaxel, Compared With Docetaxel Alone, in 2nd Line Patients With KRAS Mutation Positive Locally Advanced Metastatic NSCLC
Verified date | May 2018 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the efficacy of AZD6244 in combination with docetaxel versus docetaxel alone in patients with KRAS mutation positive locally advanced or metastatic non small cell lung cancer.
Status | Completed |
Enrollment | 88 |
Est. completion date | November 2, 2016 |
Est. primary completion date | May 11, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 130 Years |
Eligibility |
Inclusion Criteria: - Locally advanced or metastatic non small cell lung cancer (IIIB-IV) - Failure of first line anti-cancer therapy (either radiological documentation of disease progression or due to toxicity) in advanced disease or subsequent relapse of disease following first line therapy - Tumour sample confirmed as KRAS mutation positive (Note: Sample must be available upon enrolment to ship to AZ appointed central laboratory, or mutation status confirmed locally at AstraZeneca agreed local laboratory using agreed methodology, or mutation status confirmed by an accredited (eg CLIA certified) commercial laboratory (eg Genzyme or Lab 21). Exclusion Criteria: - Received >1 prior anti-cancer therapy for advanced or metastatic non small cell lung cancer (excluding radiotherapy) - Prior treatment with a MEK inhibitor or any docetaxel containing regimen (prior treatment with paclitaxel is acceptable) - Having received an investigational drug within 30 days of starting treatment, or have not recovered from side effects of an investigational drug - Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month |
Country | Name | City | State |
---|---|---|---|
Belgium | Research Site | Brussels | |
Belgium | Research Site | Charleroi | |
Belgium | Research Site | Edegem | |
Belgium | Research Site | Leuven | |
Belgium | Research Site | Liege | |
Belgium | Research Site | Liège | |
Brazil | Research Site | Belo Horizonte | |
Brazil | Research Site | Ijuí | |
Brazil | Research Site | Porto Alegre | |
Brazil | Research Site | Rio de Janeiro | |
Brazil | Research Site | Santo André | |
Brazil | Research Site | Sao Paulo | |
Brazil | Research Site | Sao Paulo | |
Brazil | Research Site | Sao Paulo | |
Bulgaria | Research Site | Plovdiv | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Sofia | |
Bulgaria | Research Site | Varna | |
Canada | Research Site | Oshawa | Ontario |
Canada | Research Site | Ottawa | Ontario |
Canada | Research Site | Toronto | Ontario |
Czechia | Research Site | Ostrava | |
Czechia | Research Site | Praha 8 | |
Czechia | Research Site | Znojmo | |
France | Research Site | Brest Cedex | |
France | Research Site | Clermont Ferrand | |
France | Research Site | Dijon | |
France | Research Site | Lyon Cedex 08 | |
France | Research Site | Marseille | |
France | Research Site | Rennes Cedex 9 | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Budapest | |
Hungary | Research Site | Györ | |
Hungary | Research Site | Mosdós | |
Hungary | Research Site | Székesfehérvár | |
Hungary | Research Site | Törökbálint | |
Italy | Research Site | Bologna | |
Italy | Research Site | Genova | |
Italy | Research Site | Milano | |
Italy | Research Site | Orbassano | |
Italy | Research Site | Perugia | |
Italy | Research Site | Roma | |
Italy | Research Site | Rozzano | |
Mexico | Research Site | Mexico | |
Mexico | Research Site | Morelia | |
Mexico | Research Site | Zacatecas | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Peru | Research Site | Lima | |
Spain | Research Site | A Coruña | |
Spain | Research Site | Badalona(Barcelona) | |
Spain | Research Site | Barcelona | |
Spain | Research Site | Madrid | |
Spain | Research Site | Malaga | |
Spain | Research Site | Málaga | |
United States | Research Site | Aurora | Colorado |
United States | Research Site | Boston | Massachusetts |
United States | Research Site | Columbus | Ohio |
United States | Research Site | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States, Belgium, Brazil, Bulgaria, Canada, Czechia, France, Hungary, Italy, Mexico, Peru, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival | OS was calculated as the interval from the date of randomisation to the date of patient death (any cause). Patients who had not died at the time of the final analysis, or who withdrew consent, were censored at the last date the patient was known to be alive. | At least 12 months since start of treatment. | |
Secondary | Progression Free Survival | PFS was defined as the interval between the date of randomisation and the earlier date of objective disease progression per RECIST criteria or death due to any cause in the absence of progression. Patients who did not progress or die at the time of analysis were censored at the time of their latest evaluable objective tumour assessment. This also included patients who withdrew consent. | At least 12 months after start of treatment | |
Secondary | Objective Response Rate | ORR is defined as the ratio of proportions, patients with at least one visit response of CR or PR in AZD6244 + Docetaxel vs Placebo + Docetaxel. | At least 12 months after start of treatment | |
Secondary | Duration of Response | Duration of response is defined as the time from the date of first documented response until date of documented progression or death in the absence of disease progression, the end of response should coincide with the date of progression or death from any cause used for the PFS endpoint. | At least 12 months after start of treatment | |
Secondary | Change From Baseline in Tumour Size at 6 Week. | Percentage change from baseline in tumour size at 6 week. Values calculated as tumour sizes at 6 weeks minus value at baseline. | 6 weeks after first dose of treatment | |
Secondary | Change From Baseline in Tumour Size at Week 12 | Percentage change from baseline in tumour size at Week 12. Values calculated as tumour sizes at 12 weeks minus value at baseline. | 12 weeks | |
Secondary | Alive and Progression-Free at 6 Months | Percentage of patients alive and progression-free at 6 months | 6 months after first dose of treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
Recruiting |
NCT05707286 -
Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
|
||
Recruiting |
NCT04258137 -
Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study
|
N/A | |
Completed |
NCT01945021 -
Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC
|
Phase 2 | |
Completed |
NCT04487457 -
Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
|
||
Terminated |
NCT04022876 -
A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection)
|
Phase 1 | |
Recruiting |
NCT05898763 -
TEIPP Immunotherapy in Patients With NSCLC
|
Phase 1/Phase 2 | |
Recruiting |
NCT05532696 -
Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients
|
Phase 1/Phase 2 | |
Completed |
NCT04311034 -
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03177291 -
Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC
|
Phase 1 | |
Terminated |
NCT03257722 -
Pembrolizumab + Idelalisib for Lung Cancer Study
|
Phase 1/Phase 2 | |
Completed |
NCT00349089 -
Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy
|
Phase 2 | |
Completed |
NCT05116891 -
A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04571632 -
Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors
|
Phase 2 | |
Terminated |
NCT03599518 -
DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer
|
Phase 1 | |
Not yet recruiting |
NCT06020989 -
Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy
|
Phase 2 | |
Withdrawn |
NCT03982134 -
PDR001 + Panobinostat for Melanoma and NSCLC
|
Phase 1 | |
Withdrawn |
NCT03574649 -
QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer
|
Phase 2 | |
Withdrawn |
NCT02844140 -
DE-CT in Lung Cancer Proton Therapy
|
N/A | |
Completed |
NCT03780010 -
Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC
|
Phase 1 |