Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC

Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV Clinical Trial

— SELECT-1  

Official title:

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination With Docetaxel, in Patients Receiving Second Line Treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT 1)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01933932
• Other study ID #: D1532C00079
• Secondary ID: 2013-001676-38
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: September 25, 2013
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Description:

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 510
• Est. completion date: December 31, 2024
• Est. primary completion date: June 7, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 130 Years

Eligibility

Inclusion Criteria:

• Provision of signed, written and dated informed consent prior to any study specific procedures
• Male or female, aged 18 years or older
• Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
• KRAS mutation positive tumour sample as determined by the designated testing laboratory
• Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy

Exclusion Criteria:

• Mixed small cell and non-small cell lung cancer histology.
• Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
• Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
• Other concomitant anti-cancer therapy agents excepts steroids
• Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
• Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced or Metastatic Non Small Cell Lung Cancer Stage IIIb - IV
• Lung Neoplasms

Intervention

Drug:
• Selumetinib
Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
• Docetaxel
Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
• Placebo
Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
• Pegylated G-CSF
All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Cordoba
Argentina	Research Site	Rosario
Australia	Research Site	Camperdown
Australia	Research Site	Chermside
Australia	Research Site	Darlinghurst
Australia	Research Site	Fitzroy
Australia	Research Site	Kogarah
Australia	Research Site	Kurralta Park
Australia	Research Site	Malvern
Australia	Research Site	Wendouree
Australia	Research Site	Woodville South
Austria	Research Site	Innsbruck
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	Vienna
Austria	Research Site	Wien
Belgium	Research Site	Brussels
Belgium	Research Site	Bruxelles
Belgium	Research Site	Bruxelles
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Roeselare
Brazil	Research Site	Barretos
Brazil	Research Site	Ijui
Brazil	Research Site	Pelotas
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	São José do Rio Preto
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Bulgaria	Research Site	Vratza
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Halifax	Nova Scotia
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Oshawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	Regina	Saskatchewan
Canada	Research Site	Saskatoon	Saskatchewan
Canada	Research Site	Surrey	British Columbia
Canada	Research Site	Toronto	Ontario
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
France	Research Site	Brest Cedex
France	Research Site	Caen
France	Research Site	Clermont Ferrand
France	Research Site	Dijon
France	Research Site	Lille
France	Research Site	Marseille Cedex 20
France	Research Site	Paris
France	Research Site	Pierre Benite Cedex
France	Research Site	RENNES Cedex 9
France	Research Site	Toulouse Cedex 09
Germany	Research Site	Augsburg
Germany	Research Site	Bad Berka
Germany	Research Site	Dortmund
Germany	Research Site	Gerlingen
Germany	Research Site	Grosshansdorf
Germany	Research Site	Halle
Germany	Research Site	Heidelberg
Germany	Research Site	Homburg
Germany	Research Site	Köln
Germany	Research Site	Löwenstein
Germany	Research Site	Moers
Germany	Research Site	München
Germany	Research Site	Ulm
Germany	Research Site	Wiesbaden
Germany	Research Site	Würzburg
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Edelény
Hungary	Research Site	Gyor
Hungary	Research Site	Kaposvár
Hungary	Research Site	Miskolc
Hungary	Research Site	Nyíregyháza
Hungary	Research Site	Törökbálint
Israel	Research Site	Beer Sheva
Israel	Research Site	Haifa
Israel	Research Site	Kfar Saba
Israel	Research Site	Petah Tikva
Israel	Research Site	Tel Hashomer
Israel	Research Site	Tel-Aviv
Italy	Research Site	Bari
Italy	Research Site	Genova
Italy	Research Site	Livorno
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Orbassano
Italy	Research Site	Parma
Italy	Research Site	Perugia
Italy	Research Site	Roma
Italy	Research Site	Roma
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Bergen Op Zoom
Netherlands	Research Site	Den Bosch
Netherlands	Research Site	Maastricht
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Miraflores
Poland	Research Site	Brzozow
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdansk
Poland	Research Site	Gdansk
Poland	Research Site	Grudziadz
Poland	Research Site	Kraków
Poland	Research Site	Lubin
Poland	Research Site	Olsztyn
Poland	Research Site	Opole
Poland	Research Site	Sucha Beskidzka
Poland	Research Site	Szczecin
Poland	Research Site	Warszawa
Portugal	Research Site	Amadora
Portugal	Research Site	Coimbra
Portugal	Research Site	Lisboa
Portugal	Research Site	Lisboa
Portugal	Research Site	Porto
Portugal	Research Site	Porto
Portugal	Research Site	Vila Nova de Gaia
Romania	Research Site	Cluj Napoca
Romania	Research Site	Cluj Napoca
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint Petersburg
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Volgograd
Spain	Research Site	Barcelona
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Sevilla
Spain	Research Site	Vigo(Pontevedra)
Spain	Research Site	Zaragoza
Sweden	Research Site	Linköping
Sweden	Research Site	Örebro
Sweden	Research Site	Uppsala
Turkey	Research Site	Ankara
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Izmir
Turkey	Research Site	Manisa
Ukraine	Research Site	Chernivts?
Ukraine	Research Site	Dnipro
Ukraine	Research Site	Kharkiv Region
Ukraine	Research Site	Kryvyi Rih
Ukraine	Research Site	Kyiv
Ukraine	Research Site	Sumy
Ukraine	Research Site	Uzhhorod
Ukraine	Research Site	Zaporizhzhia
United Kingdom	Research Site	Aberdeen
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Sutton
United Kingdom	Research Site	Wolverhampton
United States	Research Site	Atlanta	Georgia
United States	Research Site	Aurora	Colorado
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boston	Massachusetts
United States	Research Site	Chicago	Illinois
United States	Research Site	Danvers	Massachusetts
United States	Research Site	Durham	North Carolina
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Metairie	Louisiana
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Nashville	Tennessee
United States	Research Site	Nashville	Tennessee
United States	Research Site	New York	New York
United States	Research Site	New York	New York
United States	Research Site	Pembroke Pines	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  France,  Germany,  Hungary,  Israel,  Italy,  Mexico,  Netherlands,  Peru,  Poland,  Portugal,  Romania,  Russian Federation,  Spain,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)	Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary	Overall Survival (OS)	Overall Survival is defined as the time from the date of randomisation until death due to any cause.	Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Secondary	Objective Response Rate (ORR)	ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)	Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary	Duration of Response (DoR)	Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)	Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary	Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)	The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline =10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.	Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
Secondary	Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)	Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline =10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.	Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

External Links

•   CSP_redacted