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Tyrosine Kinase Inhibitor
Erlotinib for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Led By Ramaswamy Govindan
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
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Patients with known resistant mutations in the EGFR tyrosine-kinase (TK) domain (T790M) are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Pivotal Trial
Summary
This trial compares erlotinib hydrochloride to observation in treating patients with resected stage IB-IIIA non-small cell lung cancer. Erlotinib hydrochloride may stop tumor cell growth by blocking enzymes needed for cell growth.
Who is the study for?
This trial is for patients with stage IB-IIIA non-small cell lung cancer that's been surgically removed. They must have specific EGFR mutations, be fully recovered from surgery, and not pregnant or breastfeeding. No recent chemo or radiotherapy allowed, and they should have good organ function and no history of certain eye abnormalities.
What is being tested?
The study compares the effectiveness of Erlotinib Hydrochloride (a drug blocking enzymes needed for tumor growth) against a placebo in patients after surgery. It aims to see if this treatment can prevent cancer from returning.
What are the potential side effects?
Erlotinib may cause side effects like rash, diarrhea, liver problems, breathing difficulties, fatigue, mouth sores, loss of appetite and infection risk due to its action on cellular enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My cancer does not have the T790M mutation in the EGFR gene.
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My lung cancer was surgically removed, it was stage IB (>= 4 cm), II or IIIA, and I didn't receive chemo or radiotherapy before surgery.
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I have fully recovered from my surgery and it's been the right amount of time since then.
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I have no history of cornea abnormalities.
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I haven't had any cancer that spread or needed whole-body treatment in the last 5 years, nor have I been diagnosed with a new lung cancer in the last 2 years.
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My lung cancer has a specific EGFR mutation, confirmed by a central lab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS)
Secondary study objectives
Disease free survival (DFS) rate
Incidence of adverse events associated with each treatment arm
Overall disease free survival (DFS) between the erlotinib hydrochloride and observation arms
+2 moreSide effects data
From 2018 Phase 2 trial • 29 Patients • NCT0166489748%
Pneumonia
45%
Neutropenic Fever
38%
Shortness of breath
34%
Fatigue
34%
Diarrhea
31%
Lung Infection
28%
Nausea
24%
Rash
17%
Edema
17%
Muscle Aches
17%
Watery eyes
14%
Dizziness
10%
Sepsis
10%
Death
10%
Fever
3%
Tumor Lysis Syndrome
3%
Thromboembolic Event
3%
Pleuritic Pain
3%
Skin Infection
3%
Oral Mucositis
3%
Pain
3%
Seizure
3%
Blood and Lymphatic System disorder - other
3%
Espohageal Ulcer
3%
Hematoma
3%
Hyperbilirubinemia
3%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Erlotinib Hydrochloride)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Arm C (unblinded erlotinib hydrochloride)Experimental Treatment2 Interventions
Unblinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (blinded erlotinib hydrochloride)Experimental Treatment2 Interventions
Blinded patients receive erlotinib hydrochloride PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)
Group III: Arm D (observation)Active Control2 Interventions
Patients (including patients previously randomized to placebo) undergo observation at least every 6 months for 2 years.
Group IV: Arm B (placebo)Placebo Group2 Interventions
Patients receive placebo PO QD on days 1-21. Treatment repeats every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity. (CLOSED 06/14/17)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Erlotinib Hydrochloride
2010
Completed Phase 2
~2900
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,016,484 Total Patients Enrolled
Ramaswamy GovindanPrincipal InvestigatorAlliance for Clinical Trials in Oncology
2 Previous Clinical Trials
99 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My cancer does not have the T790M mutation in the EGFR gene.My lung cancer was surgically removed, it was stage IB (>= 4 cm), II or IIIA, and I didn't receive chemo or radiotherapy before surgery.I have fully recovered from my surgery and it's been the right amount of time since then.I have no history of cornea abnormalities.I haven't had any cancer that spread or needed whole-body treatment in the last 5 years, nor have I been diagnosed with a new lung cancer in the last 2 years.Your total bilirubin level is not higher than 1.5 times the upper limit of normal.Your SGOT blood test result is not more than 1.5 times the normal level.My lung cancer has a specific EGFR mutation, confirmed by a central lab.Your serum creatinine level is not more than 1.5 times the upper limit of normal.You have a healthy level of a type of white blood cell called granulocytes.You must have at least 100,000 platelets per microliter of blood.My cancer has both EGFR mutation and ALK rearrangement.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (blinded erlotinib hydrochloride)
- Group 2: Arm B (placebo)
- Group 3: Arm C (unblinded erlotinib hydrochloride)
- Group 4: Arm D (observation)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Non-Small Cell Lung Cancer Patient Testimony for trial: Trial Name: NCT02193282 — Phase 3
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