Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase III, International, Randomised, Double Blind, Parallel-Group Study to Assess the Efficacy of Zactima™ Versus Tarceva® in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Failure of at Least One Prior Chemotherapy
| Verified date | January 2018 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To determine if ZD6474 a new investigational drug, is effective in treating Non Small Lung Cancer and if so, how it compares with another type of anti cancer therapy chemotherapy, Erlotinib
| Status | Completed |
| Enrollment | 1574 |
| Est. completion date | November 2016 |
| Est. primary completion date | September 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Confirmed locally advanced or metastatic NSCLC - Failure of at least one but not more than two prior chemotherapy regimens Exclusion Criteria: - Prior treatment with erlotinib (Tarceva), gefitinib (IRESSA), sunitinib (Sutent), sorafenib (Nexavar) - Chemotherapy or other type of anti cancer therapy within 4 weeks of study start |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Ciudad de Buenos Aires | |
| Argentina | Research Site | Córdoba | |
| Argentina | Research Site | Gonnet | |
| Argentina | Research Site | Ramos Mejía | |
| Argentina | Research Site | Rosario | |
| Argentina | Research Site | Santa Fe | |
| Australia | Research Site | Ashford | |
| Australia | Research Site | Bedford Park | |
| Australia | Research Site | Chermside | |
| Australia | Research Site | Geelong | |
| Australia | Research Site | Hornsby | |
| Australia | Research Site | Kogarah | |
| Australia | Research Site | Malvern | |
| Australia | Research Site | Prahran | |
| Australia | Research Site | Wodonga | |
| Brazil | Research Site | Belo Horizonte | |
| Brazil | Research Site | Caxias do Sul | |
| Brazil | Research Site | Curitiba | |
| Brazil | Research Site | Goiânia | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Santo André | |
| Brazil | Research Site | Sao Paulo | |
| Canada | Research Site | Charlottetown | Prince Edward Island |
| Canada | Research Site | Kelowna | British Columbia |
| Canada | Research Site | Laval | Quebec |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Oshawa | Ontario |
| Canada | Research Site | Ottawa | Ontario |
| Canada | Research Site | Sault Ste. Marie | Ontario |
| Canada | Research Site | Thunder Bay | Ontario |
| Canada | Research Site | Toronto | Ontario |
| Canada | Research Site | Vancouver | British Columbia |
| Canada | Research Site | Winnipeg | Manitoba |
| Canada | Research Site | York | Ontario |
| China | Research Site | Beijing | |
| China | Research Site | Dalian | |
| China | Research Site | Hangzhou | |
| China | Research Site | Nanjing | |
| China | Research Site | Nanning | |
| China | Research Site | Shanghai | |
| China | Research Site | Shenyang | |
| China | Research Site | Wuhan | |
| Denmark | Research Site | Herlev | |
| Denmark | Research Site | København Ø | |
| Denmark | Research Site | Næstved | |
| France | Research Site | Caen | |
| France | Research Site | Clermont Ferrand | |
| France | Research Site | Marseille | |
| France | Research Site | Paris Cedex 12 | |
| France | Research Site | RENNES Cedex 9 | |
| France | Research Site | Vesoul Cedex | |
| Germany | Research Site | Göttingen | |
| Germany | Research Site | Großhansdorf | |
| Germany | Research Site | Hannover | |
| Germany | Research Site | Heidelberg | |
| Germany | Research Site | Karlsruhe | |
| Germany | Research Site | Löwenstein | |
| Germany | Research Site | Mainz | |
| Germany | Research Site | Mönchengladbach | |
| Germany | Research Site | Ulm | |
| Hong Kong | Research Site | Hong Kong | |
| India | Research Site | Bangalore | |
| India | Research Site | Karnataka | |
| India | Research Site | New Delhi | |
| India | Research Site | Pune | |
| India | Research Site | Trivandrum | |
| Indonesia | Research Site | Bandung | |
| Indonesia | Research Site | Jakarta | |
| Indonesia | Research Site | Solo | |
| Italy | Research Site | Ancona | |
| Italy | Research Site | Avellino | |
| Italy | Research Site | Catania | |
| Italy | Research Site | Genova | |
| Italy | Research Site | Mantova | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Orbassano | |
| Italy | Research Site | Parma | |
| Italy | Research Site | Perugia | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Rozzano | |
| Korea, Republic of | Research Site | Seoul | |
| Mexico | Research Site | Juchitan | |
| Mexico | Research Site | Monterrey | |
| Mexico | Research Site | Morelia | |
| Mexico | Research Site | Puebla | |
| Mexico | Research Site | Saltillo | |
| Mexico | Research Site | Zacatecas | |
| Netherlands | Research Site | Harderwijk | |
| Netherlands | Research Site | Nieuwegein | |
| Netherlands | Research Site | Rotterdam | |
| Netherlands | Research Site | Zwolle | |
| Norway | Research Site | Bergen | |
| Norway | Research Site | Haugesund | |
| Norway | Research Site | Kristiansand | |
| Norway | Research Site | Oslo | |
| Norway | Research Site | Stavanger | |
| Norway | Research Site | Tromsø | |
| Norway | Research Site | Trondheim | |
| Philippines | Research Site | Cebu City | |
| Philippines | Research Site | Davao City | |
| Philippines | Research Site | Manila | |
| Philippines | Research Site | Pasay City | |
| Philippines | Research Site | Quezon City | |
| Spain | Research Site | Elche(Alicante) | |
| Spain | Research Site | Jaén | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Málaga | |
| Spain | Research Site | Mataró(Barcelona) | |
| Spain | Research Site | Pamplona | |
| Taiwan | Research Site | Taichung | |
| Taiwan | Research Site | Tainan | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Tao-Yuan | |
| Thailand | Research Site | Bangkok | |
| Thailand | Research Site | Chiang Mai | |
| Thailand | Research Site | Lampang | |
| Thailand | Research Site | Songkla | |
| United Kingdom | Research Site | Birmingham | |
| United Kingdom | Research Site | Cambridge | |
| United Kingdom | Research Site | Leicester | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | Nottingham | |
| United Kingdom | Research Site | Sheffield | |
| United Kingdom | Research Site | Wolverhampton | |
| United States | Research Site | Amarillo | Texas |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Berkeley | California |
| United States | Research Site | Boynton Beach | Florida |
| United States | Research Site | Burien | Washington |
| United States | Research Site | Canton | Ohio |
| United States | Research Site | Chattanooga | Tennessee |
| United States | Research Site | Cincinnati | Ohio |
| United States | Research Site | Columbia | Missouri |
| United States | Research Site | Fairfax | Virginia |
| United States | Research Site | Fort Myers | Florida |
| United States | Research Site | Garland | Texas |
| United States | Research Site | Greenville | South Carolina |
| United States | Research Site | Hickory | North Carolina |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Latham | New York |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Metairie | Louisiana |
| United States | Research Site | Nashville | Tennessee |
| United States | Research Site | Norfolk | Virginia |
| United States | Research Site | Port Saint Lucie | Florida |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Saint Louis | Missouri |
| United States | Research Site | Santa Rosa | California |
| United States | Research Site | Webster | Texas |
| United States | Research Site | Wichita | Kansas |
| United States | Research Site | Yakima | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Genzyme, a Sanofi Company |
United States, Argentina, Australia, Brazil, Canada, China, Denmark, France, Germany, Hong Kong, India, Indonesia, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Philippines, Spain, Taiwan, Thailand, United Kingdom,
Natale RB, Thongprasert S, Greco FA, Thomas M, Tsai CM, Sunpaweravong P, Ferry D, Mulatero C, Whorf R, Thompson J, Barlesi F, Langmuir P, Gogov S, Rowbottom JA, Goss GD. Phase III trial of vandetanib compared with erlotinib in patients with previously tre — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable Response Evaluation Criteria In Solid Tumors (RECIST) assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions. |
progressionRECIST tumour assessments carried out every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed. | |
| Secondary | Overall Survival (OS) | Overall survival is defined as the time from date of randomization until death. Any patient not known to have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie their status must be known at the censored date and should not be lost to follow up or unknown). | Time to death in months | |
| Secondary | Objective Response Rate (ORR) | The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere and PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions. | RECIST tumour assessments every 4 weeks up to week 16 then every 8 weeks thereafter from randomisation until the date of first documented objective disease progression or date of death from any cause, whichever came first, assessed up to 21 months | |
| Secondary | Disease Control Rate (DCR) | Disease control rate is defined as the number of patients who achieved disease control at least 8 weeks following randomisation. Disease control is defined as a best objective response of complete response (CR), partial response (PR) or stable disease (SD) >= 8 weeks as determined according to RECIST 1.0. CR is defined as the disappearance of all target lesions with no evidence of tumour elsewhere, PR is defined as at least a 30% reduction in the total tumour size of measurable lesions with no new lesions and no progression in the non-target lesions and SD >= 8 is assigned to patients who have not responded and have no evidence of progression at least 8 weeks after randomisation. | RECIST tumour assessments carried out every 4 weeks until week 16 then every 8 weeks thereafter (+/- 3 days) from randomisation until objective progression | |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Pain | Pain was assessed as the average score of two items: Question 9 ("Have you had pain") and 19 ("Did pain interfere with your daily activities") of the QLQ-C30. Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. |
Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Dyspnoea | Dyspnea was assessed as the average score of four items: Question 8 of the QLQ-C30 ("Were you short of breath") and Question 3 of the QLQ-C30 ("Were you short of breath when you rested"), Questions 4 ("Were you short of breath when you walked") and 5 ("Were you short of breath when you climbed stairs") of the QLQ-LC13 (or, equivalently, Questions 33, 34 and 35 of the combined QLQ-C30 and QLQ-LC13 questionnaires). Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. |
Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit | |
| Secondary | Time to Deterioration of Disease-related Symptoms (TDS) by EORTC Quality of Life Questionnaire - Cough | Cough was assessed using Question 1 ("How much did you cough") of the QLQ-LC13 (or, equivalently, Question 31 of the combined QLQ-C30 and QLQ-LC13 questionnaires). Time to deterioration in symptoms is defined as the interval from the date of randomization to the first assessment of worsened without an improvement in the next 28 days. A patient is defined as having a deterioration in symptoms if they have a single visit assessment of 'worsened' with no visit assessment of 'improved' within the next 28 days. |
Disease-related symptom assessments are to be administered at screening (within 7 days before the first dose of study medication), every 4 weeks thereafter, at discontinuation of study treatment and at the 30-day follow-up visit |
| 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 | |
| Terminated |
NCT02628535 -
Safety Study of MGD009 in B7-H3-expressing Tumors
|
Phase 1 |