Your session is about to expire
← Back to Search
Platinum-based Chemotherapy
Chemotherapy + Erlotinib for Non-Small Cell Lung Cancer
Phase 1
Waitlist Available
Led By Tina Cascone, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
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 must have surgically resectable disease and may not be treated with prior chemotherapy or radiation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post-treatment
Awards & highlights
Study Summary
This trial is testing a combination of drugs to see if they are effective in treating non-small cell lung cancer.
Who is the study for?
This trial is for patients with stage I-III non-small cell lung cancer who've had surgery. They must have normal kidney and liver function, no prior chemotherapy or radiation, be able to handle chemo before more surgery, not be pregnant or breastfeeding, agree to use contraception, and have no severe infections or illnesses that could interfere with the study.Check my eligibility
What is being tested?
The trial tests a combination of chemotherapy drugs (docetaxel and cisplatin) with erlotinib hydrochloride on patients post-surgery. The goal is to see if this mix can better stop tumor growth by killing cells directly or blocking enzymes tumors need to grow.See study design
What are the potential side effects?
Possible side effects include reactions from the infusion of drugs like fatigue and nausea; damage to organs such as kidneys and liver due to toxicity; nerve pain from neuropathy; allergic reactions; increased risk of infection; blood disorders like low white cell count.
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.
Select...
My cancer can be removed with surgery and I haven't had chemotherapy or radiation before.
Select...
My kidney function is normal or nearly normal.
Select...
My lung cancer is confirmed and is at stage I, II, or III.
Select...
I am currently not suffering from any sudden illnesses or infections.
Select...
I can undergo chemotherapy before surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes of EGFR expression (i.e., EGFR modulation) between buccal smears and bronchial tissue
Rate of grade 3 or greater toxicities (hematologic or non-hematologic)
Secondary outcome measures
Evaluation of immune-based biomarkers
Incidence of EGFR mutations
Time to progression
Side effects data
From 2012 Phase 3 trial • 256 Patients • NCT0100568051%
Neutropenia
47%
Leukopenia
46%
Nausea
43%
Vomiting
35%
Anaemia
31%
Decreased appetite
26%
Haemoglobin decreased
26%
Fatigue
25%
Constipation
25%
White blood cell count decreased
24%
Neutrophil count decreased
19%
Alanine aminotransferase increased
13%
Platelet count decreased
12%
Rash
10%
Aspartate aminotransferase increased
10%
Thrombocytopenia
9%
Blood sodium decreased
8%
Hypokalaemia
7%
Insomnia
7%
Pyrexia
6%
Hyponatraemia
6%
Blood creatinine increased
6%
Lymphopenia
6%
Diarrhoea
6%
Dyspepsia
6%
Red blood cell count decreased
6%
Cough
4%
Dizziness
2%
Bone marrow failure
1%
Ischaemic stroke
1%
Cerebral infarction
1%
Dyspnoea
1%
Pulmonary embolism
1%
Embolism venous
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gemcitabine Plus Cisplatin (GC)
Pemetrexed Plus Cisplatin (PC)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (docetaxel, cisplatin, erlotinib hydrochloride)Experimental Treatment5 Interventions
Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning within 90 days following definitive surgical resection, patients receive erlotinib hydrochloride PO daily for up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Erlotinib Hydrochloride
2010
Completed Phase 2
~2850
Docetaxel
1995
Completed Phase 4
~5620
Erlotinib
2011
Completed Phase 4
~2290
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,458 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,321 Total Patients Enrolled
Tina Cascone, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.My cancer can be removed with surgery and I haven't had chemotherapy or radiation before.My kidney function is normal or nearly normal.My lung cancer is confirmed and is at stage I, II, or III.I am currently not suffering from any sudden illnesses or infections.I have had chemotherapy or radiotherapy for lung cancer before.I haven't taken any experimental drugs or anti-EGFR drugs in the last 30 days.I do not have any serious ongoing illnesses that would stop me from following the study's requirements.I am currently experiencing an infection that needs treatment with medication.I refuse to sign the informed consent for the trial.I am not pregnant or breastfeeding and will use birth control during and up to two months after the study.I can undergo chemotherapy before surgery.I had cancer other than melanoma over 5 years ago and have been cancer-free since.I have severe nerve damage in my hands or feet.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (docetaxel, cisplatin, erlotinib hydrochloride)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Share this study with friends
Copy Link
Messenger