Savolitinib + Osimertinib for Lung Cancer

(CoC Trial)

Recruiting at 24 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: Osimertinib

Must not be taking: CYP3A4 inducers, CYP1A2 inhibitors

Disqualifiers: Cardiac diseases, Active infection, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare the activity of the combination of savolitinib and osimertinib against the combination of savolitinib with placebo to osimertinib in patients with Epidermal Growth Factor Receptor Mutation Positive and MET amplified, locally advanced or metastatic non-small cell lung cancer who have progressed following treatment with osimertinib.

Eligibility Criteria

Adults with advanced non-small cell lung cancer (NSCLC) that has specific mutations (EGFRm+) and MET amplification, who have seen their disease progress after osimertinib treatment. They should have tried no more than three prior therapies, be in relatively good health with a life expectancy of at least 12 weeks, and agree to use contraception. Those with certain heart conditions, active infections like hepatitis or HIV, other cancers within the last five years, or severe illnesses are excluded.

Inclusion Criteria

You have a visible and measurable area of the disease that can be monitored during the trial.

I can care for myself and have not gotten worse in the past 2 weeks. Doctors expect me to live at least 12 more weeks.

My cancer progressed after treatment with osimertinib.

Exclusion Criteria

You currently have active hepatitis B or C.

I haven't taken any cancer drugs for my advanced lung cancer in the last 14 days, except for osimertinib.

I am allergic to osimertinib, savolitinib, or similar drugs.

Treatment Details

Interventions

• Osimertinib
• Savolitinib

Trial Overview The trial is testing if adding Savolitinib to Osimertinib is better than adding a placebo for patients whose NSCLC has worsened despite previous Osimertinib therapy. Participants will receive either both drugs or one drug plus a placebo to see which combination is more effective in controlling cancer growth.

Participant Groups

Group I: Arm B Experimental Treatment 1 Intervention

Savolitinib 300 mg oral QD Placebo to Osimertinib 80mg oral QD

Group II: Arm A Experimental Treatment 1 Intervention

Savolitinib 300 mg oral QD Osimertinib 80 mg oral QD

Osimertinib is already approved in United States, European Union for the following indications:

Approved in United States as Tagrisso for:

• Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
• Metastatic EGFR T790M mutation-positive NSCLC

Approved in European Union as Tagrisso for:

• Locally advanced or metastatic non-small-cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R mutations
• Metastatic EGFR T790M mutation-positive NSCLC

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