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Bcl-2 inhibitor

Osimertinib + Navitoclax for Lung Cancer

Phase 1
Waitlist Available
Led By Pasi A Janne
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Histologically confirmed non-squamous NSCLC, with incurable advanced or metastatic disease
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upup to 2 years
Awards & highlights
No Placebo-Only Group

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 Cancer
  • Non-Small Cell Lung Cancer

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have a tumor that can be measured by a standard method called Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
You have a type of lung cancer called non-squamous non-small cell lung cancer that has spread and cannot be cured.
You have been tested positive for specific mutations in your EGFR gene, which can activate cancer cells.
You have had a previous biopsy that shows your disease has progressed after treatment with a specific medication. If you do not have a recent biopsy, you must be willing to have one done before starting the trial. In some cases, if you have already been tested for a specific gene mutation, a new biopsy may not be necessary for a certain part of the trial.
For the second part of the study, you must have a specific type of tumor that tests positive for EGFR-T790M and have not received a certain type of medication for it before.
You have already undergone treatment for your condition with a medication called EGFR TKI, and your disease has progressed. You may have had other treatments before or after EGFR TKI, but you cannot have had a specific type of EGFR TKI called third-generation EGFR TKI for the expansion phase of the trial.
You can swallow pills or tablets.
There are no limits on the number of treatments you have received in the past.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Feasibility of the combination therapy in T790M+ lung cancer (dose expansion)
Incidence of toxicity (dose escalation)
Secondary outcome measures
Biomarkers of apoptosis such as BCL2-like 1 (BCL-XL) and BCL2-like 11 (apoptosis facilitator) (BIM) levels in tumor tissue
Change in plasma concentration of EGFR T790M and other EGFR mutations
Objective response rate
+1 more

Side effects data

From 2020 Phase 4 trial • 60 Patients • NCT03853551
Blood creatine phosphokinase increased
Decreased appetite
Mucosal inflammation
Pain in extremity
Cardio-respiratory arrest
Mouth Ulceration
Dengue fever
Disease progression
Deep Vein Thrombosis
Study treatment Arm
Single Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (navitoclax, osimertinib)Experimental Treatment2 Interventions
Patients receive navitoclax PO QD on days 1-28 and osimertinib PO QD on days 4-28 (days 1-28 during dose-expansion). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4
Completed Phase 2

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,486 Previous Clinical Trials
41,264,827 Total Patients Enrolled
Pasi A JannePrincipal InvestigatorDana-Farber - Harvard Cancer Center LAO
1 Previous Clinical Trials
188 Total Patients Enrolled

Media Library

Navitoclax (Bcl-2 inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02520778 — Phase 1
Lung Carcinoma Research Study Groups: Treatment (navitoclax, osimertinib)
Lung Carcinoma Clinical Trial 2023: Navitoclax Highlights & Side Effects. Trial Name: NCT02520778 — Phase 1
Navitoclax (Bcl-2 inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02520778 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At what number of institutions is this research experiment being conducted?

"This research is actively enrolling patients at Duke University Medical Center, UC Davis Comprehensive Cancer Center, and UPCI with an additional 18 sites."

Answered by AI

Has this medical experiment been conducted before?

"Since 2009, research has been conducted on the effectiveness of Osimertinib. The initial clinical trial was organised by AbbVie (previously Abbott) and included 29 participants. Subsequent to this study, Phase 1 drug approval for osimertinib was granted; presently there are 112 active trials located across 54 countries in over 1000 cities."

Answered by AI

Are new participants being accepted for this trial at present?

"This clinical trial has ceased to accept enrollment, having initially gone live on March 31st 2016 and last updated on August 2nd 2022. Fortunately for those seeking other studies, there are 3,657 non-small cell lung carcinoma trials currently recruiting as well as 112 osimertinib studies with available spots."

Answered by AI

What prior research has been conducted concerning the efficacy of Osimertinib?

"Presently, 19 trials for Osimertinib are in the third phase of development and 112 studies researching this drug exist. Though most of these tests take place at Uniondale in New York State, there is a total of 5506 clinical trial sites that offer it."

Answered by AI

What is the quota for enrollees of this research endeavor?

"This clinical trial has ended, with the initial post on March 31st 2016 and last update dated August 2nd 2022. If you are seeking other trials for non-small cell lung carcinoma, 3657 studies are presently recruiting patients while 112 research projects include Osimertinib as a prospective treatment option."

Answered by AI

Is Osimertinib associated with any unfavorable side effects?

"Due to the limited data on osimertinib's safety and efficacy, our team evaluated its risk as a 1 on a scale of one to three."

Answered by AI

What are the intended outcomes of this research project?

"The primary outcome of this trial, to be measured over a 12 week period (3 cycles), is the incidence of toxicity during dose escalation. Secondary outcomes include biomarkers of apoptosis such as BCL-XL and BIM levels in tumor tissue, pharmacokinetics parameters related to osimertinib with navitoclax dosing changes, and an exploration into change in plasma concentration of EGFR T790M mutations relative to imaging responses."

Answered by AI
~4 spots leftby Jul 2024