Osimertinib for Non-small Cell Lung Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Non-small Cell Lung CancerOsimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying how well the combination of these two drugs works in treating patients with NSCLC that has an EGFR mutation.

Eligible Conditions
  • Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 2 years

2 years
Best Objective Response
Overall Survival
Progression Free Survival
Tolerability
Tolerability Proportion
Toxicity
Toxicity Grading

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Single Arm
10%Blood creatine phosphokinase increased
10%Fatigue
8%Decreased appetite
8%Diarrhoea
8%Cough
7%Thrombocytopenia
7%Pain in extremity
7%Constipation
7%Rash
7%Mucosal inflammation
7%Paronychia
3%Dyspnoea
2%Cataract
2%Cardio-respiratory arrest
2%Deep Vein Thrombosis
2%Mouth Ulceration
2%Dengue fever
2%Disease progression
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT03853551) in the Single Arm ARM group. Side effects include: Blood creatine phosphokinase increased with 10%, Fatigue with 10%, Decreased appetite with 8%, Diarrhoea with 8%, Cough with 8%.

Trial Design

1 Treatment Group

Osimertinib + Selumetinib
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: Osimertinib · No Placebo Group · Phase 2

Osimertinib + SelumetinibExperimental Group · 2 Interventions: Selumetinib, Osimertinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
FDA approved
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

National Comprehensive Cancer NetworkNETWORK
108 Previous Clinical Trials
5,513 Total Patients Enrolled
2 Trials studying Non-small Cell Lung Cancer
76 Patients Enrolled for Non-small Cell Lung Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,017 Previous Clinical Trials
393,803 Total Patients Enrolled
8 Trials studying Non-small Cell Lung Cancer
435 Patients Enrolled for Non-small Cell Lung Cancer
Pasi A Janne, MD, PhDPrincipal InvestigatorDana-Farber Cancer Institute
5 Previous Clinical Trials
756 Total Patients Enrolled
2 Trials studying Non-small Cell Lung Cancer
137 Patients Enrolled for Non-small Cell Lung Cancer

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Participants must have histologically confirmed stage IV NSCLC (per AJCC 7th edition) with either the L858R or exon 19 deletion activating EGFR mutation as identified in a CLIA-approved laboratory.
You are eligible if you have no prior history of EGFR-directed therapy, including TKIs or antibodies, and are also chemotherapy and immunotherapy naïve for metastatic disease.
You have an ECOG performance status of 0-1.
You have a platelet count of at least 100,000/mcL.
Patients with hemoglobin >9.0 g/dL are eligible.