Selumetinib + Docetaxel for Lung Cancer

(SELECT-1 Trial)

Recruiting at 165 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Pasi Jänne, MD

Principal Investigator

Dana-Faber Cancer Institute, USA

Gabriella Mariani, MD

Principal Investigator

AstraZeneca UK, MSD

Eligibility Criteria

This trial is for adults over 18 with advanced or metastatic non-small cell lung cancer (NSCLC) that's KRAS mutation positive. They must have had one failed anti-cancer therapy but can't have had MEK inhibitors, docetaxel regimens, other recent cancer treatments, or certain types of radiation.

Inclusion Criteria

Provision of signed, written and dated informed consent prior to any study specific procedures

You are 18 years old or older.

You have been diagnosed with advanced or metastatic non-small cell lung cancer.

Exclusion Criteria

Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment

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

You have a type of lung cancer that is a mix of small cell and non-small cell types.

Treatment Details

Interventions

• Docetaxel (Taxane)
• Placebo (Other)
• Selumetinib (MEK Inhibitor)

Trial Overview The study tests the effectiveness of Selumetinib combined with Docetaxel against a placebo plus Docetaxel in patients with KRAS mutated NSCLC. It will also evaluate how the body processes the drugs, their safety, and patient-reported outcomes.

Participant Groups

Group I: Selumetinib + Docetaxel Experimental Treatment 3 Interventions

Three 25mg Selumetinib 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

Group II: Placebo + Docetaxel Experimental Treatment 3 Interventions

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.

Docetaxel is already approved in Canada, Japan for the following indications:

Approved in Canada as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Approved in Japan as Taxotere for:

• Breast Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Head and Neck Cancer
• Prostate Cancer

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology