Osimertinib for Non-Small Cell Lung Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Non-Small Cell Lung Carcinoma+7 More
Osimertinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies the side effects and best dose of osimertinib and navitoclax when given together to treat patients with EGFR-positive non-small cell lung cancer.

Eligible Conditions
  • Non-Small Cell Lung Carcinoma
  • Lung
  • Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Baseline
Biomarkers of apoptosis such as BCL2-like 1 (BCL-XL) and BCL2-like 11 (apoptosis facilitator) (BIM) levels in tumor tissue
Year 2
Change in plasma concentration of EGFR T790M and other EGFR mutations
Day 30
Objective response rate
Day 3
Pharmacokinetics parameters (maximum observed plasma drug concentration, area-under-the concentration-time-curve, trough drug concentration at steady state, and half-life) of osimertinib in combination with navitoclax
Week 12
Feasibility of the combination therapy in T790M+ lung cancer (dose expansion)
Up to 2 years
Incidence of toxicity (dose escalation)

Trial Safety

Safety Progress

1 of 3

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

Treatment (navitoclax, osimertinib)
1 of 1

Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Osimertinib · No Placebo Group · Phase 1

Treatment (navitoclax, osimertinib)Experimental Group · 2 Interventions: Navitoclax, Osimertinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Navitoclax
Not yet FDA approved
Osimertinib
FDA approved

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,005 Previous Clinical Trials
41,301,877 Total Patients Enrolled
Pasi A JannePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
188 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have histologically confirmed non-squamous NSCLC, with incurable advanced or metastatic disease.
Patient must have a tumor which is EGFR-T790M positive and be treatment naive to T790M-directed EGFR TKI (e.g
You have measurable disease per RECIST 1.1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.