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Alkylating Agent
Chemotherapy + Nintedanib for Lung Cancer
Phase 1
Waitlist Available
Led By Tina Cascone
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 score 0-1
All patients must have lymph node evaluation of contralateral stations 2 and/or 4 to exclude N3 disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial studies the safety and best dose of drugs to treat lung cancer before surgery.
Who is the study for?
This trial is for adults with previously untreated stage IB-IIIA non-small cell lung cancer who are fit for surgery, have good performance status (able to carry out daily activities), and no history of significant bleeding or clotting events. They must not have had prior treatments for their lung cancer, no serious infections or illnesses that could interfere with the study, and they should be willing to use contraception if applicable.Check my eligibility
What is being tested?
The trial tests how well patients respond to a combination of chemotherapy drugs Cisplatin and Docetaxel along with Nintedanib—an enzyme inhibitor—before undergoing surgery. The aim is to shrink the tumor and limit the amount of normal tissue removed during surgery.See study design
What are the potential side effects?
Possible side effects include nausea, fatigue, increased risk of infection due to low blood counts, liver function changes, bleeding or clotting issues. There may also be specific reactions related to Nintedanib such as high blood pressure and gastrointestinal symptoms.
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 lymph nodes in specific areas have been checked to rule out advanced cancer.
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My cancer is at a specific stage and hasn't spread to more than one lymph node near my lungs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Major pathologic response rate, defined as less than or equal to 10% viable tumor cells in the resected specimen using the methods described by Pataer
Maximum tolerated dose (MTD) of nintedanib
Secondary outcome measures
Change in tumor size (Expansion phase)
Response rate after single-agent nintedanib (Expansion phase)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (cisplatin, docetaxel, nintedanib)Experimental Treatment4 Interventions
RUN-IN PHASE: Patients receive induction therapy comprising cisplatin IV over 2 hours on day 1, docetaxel IV over 1 hour on day 1, and nintedanib PO BID from day 2 of course 1 to day 7 of course 3. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.
EXPANSION PHASE: Patients receive single-agent nintedanib PO BID on days 1-28. Patients then receive 3 courses of induction chemotherapy and undergo surgery as above. Treatment continues even if patients experience disease progression, unless treatment is judged to be not in the best interest of the patient by the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Docetaxel
1995
Completed Phase 4
~5620
Nintedanib
2015
Completed Phase 4
~3980
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,975 Previous Clinical Trials
1,789,493 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,675 Previous Clinical Trials
40,926,951 Total Patients Enrolled
Tina CasconePrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
103 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a major injury within the last 10 days and my wound has not fully healed.I do not have serious heart conditions such as uncontrolled high blood pressure, recent heart attacks, or severe heart failure.I have not had serious bleeding or blood clot issues in the last 6 months.My kidney function is within the required range for the study.I do not have any serious illness or condition that could make this study unsafe for me.Your prothrombin time (PT) and partial thromboplastin time (PTT) are more than 50% higher than the normal limits at the hospital.Your white blood cell count is too low, or your platelet count is too low.I am fully active or can carry out light work.Your bilirubin or AST levels are too high.I do not have any serious infections requiring antibiotics.I have or had hepatitis B or C.My lymph nodes in specific areas have been checked to rule out advanced cancer.I have signed and understand the consent form according to international and local laws.I have received treatments like chemotherapy or radiation for my current lung cancer.My tumor is near the center of my body and is affecting major blood vessels.I have a genetic condition that affects my blood clotting.My cancer is at a specific stage and hasn't spread to more than one lymph node near my lungs.My lung cancer is confirmed and not a neuroendocrine type.My doctor thinks I am a good candidate for surgery.I have had cancer treatment within the last year.Things like personal, family, or location issues that might make it difficult for you to follow the study's rules and schedule.Your blood clotting test result is higher than 2.I do not have stomach or intestine problems that affect medication absorption.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cisplatin, docetaxel, nintedanib)
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.
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