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)

Not Applicable

• Conditions: -C34 Malignant neoplasm of bronchus and lung; Malignant neoplasm of bronchus and lung; C34

• Registration Number: PER-071-13
• Lead Sponsor: ASTRAZENECA PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-02-26
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

1. Provision of informed consent prior to any study specific procedures
2. Male or female, aged 18 years or older
3. Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
4. Failure of 1st line anti-cancer therapy (either radiological documentation of disease
progression or due to toxicity) in advanced disease or subsequent relapse of disease following 1st line therapy. Patients who received adjuvant/neoadjuvant chemotherapy and develop a recurrence, with evidence of stage IIIB-IV disease within 6 months of completing chemotherapy, may be eligible. See Appendix G for further details
5. WHO Performance Status 0 – 1
6. Patients must be eligible to receive treatment with docetaxel in accordance with local prescribing information
7. At least one lesion, not previously irradiated, that can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes which must have
short axis ≥ 15 mm) with computed tomography (CT) or magnetic resonance
imaging (MRI) and which is suitable for accurate repeated measurements.
8. KRAS mutation positive tumour sample as determined by the designated testing
laboratory
More details in page 53 of protocol in english, not enough room to include it in this section

Exclusion Criteria

1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
2. Previous randomisation in the present study
3. Mixed small cell and non-small cell lung cancer histology
4. 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
5. Having received an investigational drug within 30 days of first dose of study treatment or within five half-lives of the compound (whichever is the most appropriate is at the discretion of the investigator), or have not recovered from side effects of an investigational drug
6. Receiving or have received systemic anti-cancer therapy within 4 weeks prior to
starting study treatment (6 weeks for nitrosoureas, mitomycin, and suramin), or any
anticancer therapy which has not been cleared from the body by the time of starting study treatment
7. Prior treatment with a MEK inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable)
8. Any unresolved toxicity > or equal CTCAE Grade 2 from previous anti-cancer therapy, apart from alopecia
More details in page 54 of protocol in english, not enough room to include it in this section

Study & Design

• Study Type: Interventional
• Study Design: Not specified